Category Archives: Psoriasis

NORTH CHICAGO, Ill., March 17, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplementalNew Drug Application (sNDA) for upadacitinib in the treatment of adult patients with active psoriatic arthritis. The updated Prescription Drug User Fee Act (PDUFA) action date has been extended three months to late Q2 2021.

AbbVie recently received an information request from the FDA for an updated assessment of the benefit-risk profile for upadacitinib in psoriatic arthritis. AbbVie responded to the request and the FDA will require additional time for a full review of the submission.

Separately, AbbVie received a similar request from the FDA related to the sNDA for upadacitinib in atopic dermatitis, which is being prepared and will be submitted to the FDA shortly.

"We remain confident in the sNDA and are committed to working with the FDA to bring upadacitinib to patients living with psoriatic arthritis and other immune-mediated diseases," saidMichael Severino, M.D., vice chairman and president, AbbVie.

About Upadacitinib (RINVOQ)

Discovered and developed by AbbVie scientists, RINVOQ is an oral, once daily, selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases.It was engineered to have greater inhibitory potency for JAK1 versus JAK2, JAK3 and TYK2.InAugust 2019, RINVOQ received U.S. Food and Drug Administration approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is also approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs); active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs and active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. The approved dose for RINVOQ in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is 15 mg. Phase 3 trials of RINVOQ in ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis and giant cell arteritis are ongoing.

Important Safety Information about RINVOQ (upadacitinib)

RINVOQ U.S. Use and Important Safety InformationRINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.

What is the most important information I should know about RINVOQ?RINVOQ is a medicine that can lower the ability of your immune system to fight infections. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay.

What should I tell my HCP BEFORE starting RINVOQ?Tell your HCP if you:

Tell your HCP about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

Especially tell your HCP if you take:

Ask your HCP or pharmacist if you are not sure if you are taking any of these medicines.

What should I tell my HCP AFTER starting RINVOQ?Tell your HCP right away if you:

What are the common side effects of RINVOQ?These include: upper respiratory tract infections (common cold, sinus infections), nausea, cough, and fever. These are not all the possible side effects of RINVOQ.

RINVOQ is taken once a day with or without food. Do not split, break, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it.

This is the most important information to know about RINVOQ. For more information, talk to your HCP.You are encouraged to report negative side effects of prescription drugs to the FDA. Visithttp://www.fda.gov/medwatchor call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. VisitAbbVie.com/myAbbVieAssistto learn more.

Please click here for theFull Prescribing InformationandMedication Guide.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVieAbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com/. Follow @abbvie on Twitter, Facebook, Instagram, YouTubeand LinkedIn.

Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2020 Annual Report on Form 10-K, which has been filed with theSecurities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

SOURCE AbbVie

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AbbVie Announces Extension of Review for Supplemental New Drug Application of Upadacitinib for the Treatment of Adults with Active Psoriatic Arthritis...

Introduction

Psoriasis is a chronic, inflammatory, recurrent, and noninfectious skin disease affecting 24% of the global population. It can occur in both sexes at any age, and the development of the disease is stimulated by various genetic, immunological and environmental factors, which could be interrelated to some degree. Psoriasis is manifested by increased proliferation of the epidermis, which, along with inflammation, leads to skin lesions of varying severity.1,2 Nowadays, patients with moderate-to-severe psoriasis are treated with conventional immunosuppressants or with new biological agents, with milder cases being most often treated topically. Phototherapy is the first-line treatment for patients for whom topical therapy is insufficient.3

Various types of phototherapy have been developed. Among them broadband ultraviolet (UV) B light (UVB, range: 290315 nm) was the first to be used. However, it was later replaced by more effective narrowband (NB)-UVB (311313 nm) phototherapy. Nowadays, NB-UVB treatment is still extensively used for plaque psoriasis.4,5 Moreover, NB-UVB is a highly economical and safe treatment that could avoid or delay starting more expensive third-line treatments for psoriasis.6

Although numerous studies have been carried out, it is difficult to predict the outcome of phototherapy in individual patients. There are numerous suggestions that machine learning models developed in recent years could estimate the outcome of treatment without predetermining medical pathways for psoriasis. Random forest (RF) methodology and the related free access RF software appear very promising when searching for complex heterogeneous and high dimensionless data when a link between input and output variables could not be revealed due to unrecognized relationships among the models predictors and their complicated influences on output variables.7,8 RF could deal with a large number of input parameters, even larger than the number of output samples, without the need for deleting some input variables to reduce dimensionality. RF models have been used to solve various biological/medical problems and have also found applications in dermatology.912

The objectives of this study are prediction of outcome of the phototherapy in terms of good (or bad) response to NB-UVB phototherapy, short (or long) duration of remission, and identifying patients who will resign from further follow-up visits and possible treatments after completing the first phototherapy course. These objectives are important for making clinical decisions based on output of the RF classifier.

Eighty-two adult patients with plaque-type psoriasis, for whom the NB-UVB phototherapy was recommended, were recruited for the study. There were 42 men and 40 women with a mean age of 55 years and seven months (range: 2476 years). Patients with a moderate-to-severe psoriasis, ie having Psoriasis Area and Severity Index (PASI) >10 and awaiting NB UVB therapy, were selected for the study. The patients voluntarily agreed to take part in additional blood tests. All the participants were advised not to apply active topical treatment during the phototherapy sessions, not to use sunbeds, and to avoid sunbathing. The study was conducted in accordance with the Declaration of Helsinki. Data acquisition and analysis were performed in compliance with protocols approved by the Ethical Committee at the Medical University of d (MUL), ethical approval number RNN/219/18/KE. Written informed consent was obtained from all participants prior to the study.

Outcomes of psoriatic patients treated with NB-UVB phototherapy at the Department of Dermatology MUL were examined. Fluorescent tubes (Phillips TL01) were used to expose patients in a medical cabinet. All patients underwent the same standard phototherapy procedure with 20 treatments.

The mean initial dose was ~0.15 Jul cm2 (depending on the patients phototype) at the start of phototherapy and was gradually increased by approximately 10% with each subsequent treatment to avoid the development of erythema depending on the patients skin reaction. The maximum dose reached ~1.5 Jul cm2. NB-UVB phototherapy was administrated three times weekly, typically for six to eight weeks.

The MUL phototherapy cabinet needed to be calibrated due to the expected aging of the discharge tubes. It was done twice a year by the outer calibration campaigns. Independent occasional measurements by the handheld radiometer ILT 1400, Quantum Design, confirmed the accuracy of the calibration procedure.

The database includes all psoriatic patients (n=82) attending NB-UVB phototherapy. It consists of three parts: the firstanswers to a questionnaire, the secondresults of medical tests carried out before and after each round of the cabinet exposures, the thirdvalues of Psoriatic Severity Measures (PSM): PASI, body surface area (BSA), and Physician Global Assessment (PGA), obtained before and after each course of the exposures. Data can be shared with other users upon request.

The first part of the database (n=82) contains the answers from the questionnaire grouped into following categories:

The second part of database (n=71) contains numerical values obtained from various medical blood tests collected during the study. These were as follows:

The third part of the database contains PSM scores and their changes due to the therapy. The following values are stored:

The effectiveness of NB-UVB phototherapy is determined from changes of PASI, BSA, and PGA, after the first (n=71) and second (n=21) course of the NB-UVB treatment. For all these metrics, the percentage change relative to the baseline value at the start of new course of the 20 exposures is calculated (denoted as PASI, BSA, and PGA). The phototherapy outcome is compared after each course of the exposures and separately for two sub-groups: present in both successive courses or only in the first course.

Standard statistical parameters (mean value, standard deviation, median, and the minimum-maximum range) are calculated to find out the metrics differences between two successive rounds of NB-UVB exposure. Moreover, the statistical significance of the differences between the outcomes are calculated using:

Descriptive statistics and testing are from analytic software package, Statistica, TIBCO Software Inc. (https://www.tibco.com/products/data-science).

Answers to the questionnaire prior to the first course of phototherapy and results of various medical tests at the beginning and end of each course of NB-UVB treatments provide a set of potential predictors to be used by the RF classifier. PASI is the best rating scale for assessing the psoriasis severity and it is well correlated with other scales.13 Thus, for the purpose of the RF classification of the NB-UVB phototherapy outcome, only the PASI scores are considered.

All PASI values after the first exposure round and duration of remission were ordered (from the poorest to the best outcome). The ordered PASI data (n=71) were divided into two groups below (n=25) and above (n=46) the threshold of PASI=50%. For examination of the duration of remission, the threshold was set as the median value (eight weeks), so there were two sub-groups with short (below the median with the median inclusive) and long duration of remission (above the median). Some patients missed the second course of the NB-UVB exposures after completing the first course. Two sub-groups thus emerged, absent (n=44) and present (n=27) in the second course of the therapy. RF classifier is used to predict in advance (before phototherapy) which patients belong to the above mentioned sub-groups.

The RF classification was optimized by examining different sets of the initial setup parameters. We decided to use the model with the greatest accuracy and with the smallest possible number of the explanatory variables. The classification of the psoriatic patients is carried out implementing RF source programs available on public web page: https://www.stat.berkeley.edu/~breiman/RandomForests/cc_software.htm

Figure 1 and Table 1 show results of statistical analyses of relative changes (in % of values at the beginning of phototherapy) of PASI, BSA, and PGA, due to the phototherapy. Improvement in psoriasis could be seen in all considered indices. The mean values of the relative changes are: ~60% (PASI), ~4050% (BSA and PGA).

Figure 1 Box and whisker plot for the relative change in psoriatic severity measure (as a percentage of the value at the start of phototherapy), after the first and second rounds of 20 narrowband UVB exposures.

Abbreviations: BSA, body surface area; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment.

Table 1 Statistical Characteristics of the Phototherapy After the First and Second Courses of NB-UVB Phototherapy for Various Groups of Patients

The statistical tests confirm the hypothesis that there is no change of the statistical distribution for each PSM when comparing outputs of the first and the second rounds of the NB-UVB exposures (see Table 1 for all probability values >0.05).

The patients, who attended only the first course of phototherapy, had almost a similar outcome of phototherapy (for all psoriatic severity measures) when compared to patients continuing phototherapy after relapse. There was no significant difference in therapy outcomes after the first and second courses.

The mean duration of remission was about two months. The first patient returns for the next round of phototherapy after two weeks, but the last one after eight months. It is unlikely that duration of remission was longer than the project duration of three years.

Two versions of the RF model, ie with all possible and limited number of the predictors (excluding the cytokine data), are considered. The latter model is a low-cost option for the classification as only standard blood tests are examined. Its performance (Table 2) is shown for the following groups: the bad (PASI 50) or good (PASI >50) effectiveness of the therapy, short (8 weeks) or long duration (>8 weeks) of remission, and presence or absence in the second course of phototherapy. Statistics used to quantify the results of the RF model are in line with the 22 contingency table analysis standard, including: sensitivity, specificity, predictive values, likelihood ratios, and overall accuracy.14

Table 2 Statistical Characteristics of the RF Classification, without Cytokine Input, for Various Sub-Groups of the Psoriatic Patients

RF classifier appears as a useful tool for identifying in advance the patients sub-groups. Its sensitivity is over 84%, and accuracy is of 75% (for good and bad outcome), 85% (short and long remission), and 79% (absence and presence in the second course). Positive and negative likelihood ratios are significantly larger and lower than one, respectively. If a value of 1.0 is within the 95%CI, the prediction is no better than a coin toss. Moreover, for all cases, positive prediction value (PPV) is of ~80% and the 95%CI is over the 50% level of random forecast. This confirms the usefulness of the prediction of the positive effect by RF classifier. In only one case, ie prediction of a bad result of the phototherapy, the 95%CI of negative predictive value (NPV) contains 50%, ie the prediction can be like a coin toss. Positive effects are better predicted then negative ones in terms of smaller range of 95%CI and larger sensitivity (>84%) compared to specificity (~5570%). Using a larger number of possible predictors (ie blood tests including cytokine data) at the start of the RF classification surprisingly did not improve its accuracy.

Improvement in psoriasis due to NB-UVB phototherapy was found. However, the vast majority of the patients (~70%) attending the first course of therapy did not return to the department for further appointments. The comparison of the psoriasis severity scores in patients who participated in two successive phototherapy courses with those completing only the first course of treatment showed that their worse outcome of phototherapy was not a reason to quit follow-up appointments.

The RF classifier is able, ie both PPV and NPV are significantly >50%, to identify in advance the patients who will attend phototherapy courses or quit after the first course. The classification by RF can also effectively identify those who will have a short or long duration of relapse. The RF classification only fails (ie 95%CI of NPV contains 50%) to identify patients with a bad outcome of the phototherapy. However, in this case, the RF tool helps to select the patients to be closely supervised during phototherapy as they may need a different form of therapy.

RF classifier selects the best set of predictors (Table 3) from initial large set of potential predictors and provides the ranking of the predictors (from the best to the worst). The accuracy of RF classifier using a limited number of starting predictors (without cytokine data) is even better than the RF classifier with more potential predictors (with cytokine data) at the start. Thus, it is enough to use a few standard medical tests and a questionnaire for building a limited database to serve as RF input. However, the model response to the selected single predictor cannot be quantified. This requires the use of other models (eg logistic regression for modelling binary outcome).

Table 3 Ranking of Explanatory Variables from Most Important to Least Important

The list of potential variables explaining outcome of the NB-UVB therapy is not fixed and could be extended and adapted to local circumstances and the patients profile (by entering additional medical tests and questions to the questionnaire). Therefore, before any psoriatic therapy, the artificial intelligence tool will be able to identify patients for whom NB-UVB phototherapy should be the first choice. This method requires further validation in a larger and a more diverse cohort but seems to be very promising. Despite the small number of patients enrolled in this study, the RF classifier shows that many predictions are much better than a coin toss.

We present the method that helps to identify psoriatic patients in whom phototherapy will significantly improve their skin, or those in whom other therapies should be recommended beforehand. For patients who may avoid subsequent follow-up visits, some preventive actions can be taken to change their attitude toward the treatment.

RF classification tool does not yet have practical applications in todays standard of the psoriasis treatment. The article presents preliminary results that individual patients data (from low-cost blood tests and patients questionnaire) can be transformed, using the RF tool, into valuable information-facilitating decision-making by doctors.

BMI, body mass index; BSA, body surface area; DLQI, dermatology life quality index; NB-UVB, narrow band ultraviolet B; NPV, negative predictive value; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PPV, positive prediction value; PSM, psoriatic severity measure; RF, random forest.

This research was funded by the Polish National Science Centre grant project no. UMO-2013/11/B/NZ5/00037. JN, AL, MS, and MN are supported by statutory activities no. 503/5-064-04/503-01. JK, PS, and BR are supported by statutory activities no. 3841/E-41/S/2019.

The authors report no conflicts of interest in this work.

1. Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009;361:496509. doi:10.1056/NEJMra0804595

2. World Health Organization (WHO). Global report on psoriasis. 2016. Available from: https://apps.who.int/iris/handle/10665/204417. Accessed February 1, 2021.

3. Wan J, Abuabara K, Troxel AB, et al. Dermatologist preferences for first-line therapy of moderate to severe psoriasis in healthy adult patients. J Am Acad Dermatol. 2012;66(3):376386. doi:10.1016/j.jaad.2011.03.012

4. Higgins E. Psoriasis. Medicine. 2017;45(6):368378. doi:10.1016/j.mpmed.2017.03.010

5. Zhang P, Wu MX. A clinical review of phototherapy for psoriasis. Lasers Med Sci. 2018;33(1):173180. doi:10.1007/s10103-017-2360-1

6. Boswell K, Cameron H, West J, et al. Narrowband ultraviolet B treatment for psoriasis is highly economical and causes significant savings in cost for topical treatments. Br J Dermatol. 2018;179(5):11481156. doi:10.1111/bjd.16716

7. Breiman L. Random forest. Mach Learn. 2001;45:532. doi:10.1023/A:1010933404324

8. Breiman L, Cutler A. Random forests. Available from: https://www.stat.berkeley.edu/users/breiman/RandomForests/. Accessed February 1, 2021.

9. Inza I, Calvo B, Armaanzas R, Bengoetxea E, Larraaga P, Lozano JA. Machine learning: an indispensable tool in bioinformatics. Methods Mol Biol. 2010;593:2548. doi:10.1007/978-1-60327-194-3_2

10. Lebedev AV, Westman E, Van Westen GJ, et al. Random forest ensembles for detection and prediction of alzheimers disease with a good between-cohort robustness. NeuroImage Clin. 2014;6:115125. doi:10.1016/j.nicl.2014.08.023

11. Denisko D, Hoffman MD. Classification and interaction in random forests. Proc Natl Acad Sci U S A. 2018;115(8):16901692. doi:10.1073/pnas.1800256115

12. Janney JB, Roslin S. Classification of melanoma from dermoscopic data using machine learning techniques. Multimedia Tools Appl. 2020;79:37133728. doi:10.1007/s11042-018-6927-z

13. Bachmann F. Evaluation of disease severity: clinical scores and questionnaires. In: Sterry W, Sabat R, Phillipp S, editors. Psoriasis, Diagnosis and Management. UK: Publishers John Wiley & Sons Ltd; 2014:129139. doi:10.1002/9781118661796.ch14

14. Parshall MB. Unpacking the 2 x 2 table. Heart Lung. 2013;42(3):221226. doi:10.1016/j.hrtlng.2013.01.006

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[Full text] A Priori Estimation of the Narrow-Band UVB Phototherapy Outcome for Mo | CCID - Dove Medical Press

Guselkumab was a safe and effective treatment for biologic-nave patients with psoriatic arthritis (PsA), according to one-year data from a phase 3 study.

Guselkumab, a human monoclonal antibody specific to interleukin23p19, demonstrated efficacy and safety versus placebo through week 24 of the phase III DISCOVER2 trial in biologicnaive patients with PsA. Here we report 1year DISCOVER2 findings, the researchers explained.

The study included adult patients with PsA who had at least five swollen and five tender joints as well as Creactive protein level 0.6 mg/dl despite nonbiologic treatment. Patients were randomized to receive guselkumab 100 mg every four weeks; guselkumab 100 mg at week zero, week four, and every eight weeks thereafter; or placebo with crossover to guselkumab 100 mg every four weeks at week 24.

A total of 739 patients were randomized and treated, and 93% completed the study up to week 52. The proportions of patients who achieved at least a 20% improvement in American College of Rheumatology criteria (ACR20) was maintained after week 24; by week 52, in the treatment every four weeks group, it was 71%, and in the every eight weeks group, 75%. The proportions of patients who achieved ACR50, ACR70, skin responses, minimal or very low disease activity, and dactylitis or enthesitis resolution by week 24 also maintained through week 52. Continued treatment was associated with low levels of radiographic progression and improved physical function and health-related quality of life through week 52. The rates of serious infections through week 52 were low. There were no opportunistic infections or deaths reported.

The study was published in Arthritis & Rheumatology.

In conclusion, guselkumab 100 mg every 4 weeks or every 8 weeks effectively treated the diverse manifestations of active PsA in biologicnaive patients. The overall treatment effect observed during the 24week placebocontrolled period was well maintained, and the riskbenefit profile remained favorable for both guselkumab regimens, through week 52 of DISCOVER2, the researchers summarized in their conclusion.

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Guselkumab Safe, Effective in Biologic-nave Patients with Psoriatic Arthritis - DocWire News

A phase 3 clinical trial of mirikizumab in ulcerative colitis has met its primary endpoint, boosting Eli Lillys hopes of establishing the anti-IL-23p19 antibody in gastrointestinal disorders.

Lilly has ceded a head start to AbbVies anti-IL-23 antibody Skyrizi and Johnson & Johnsons Stelara, which hits IL-12 and IL-23, in plaque psoriasis. Faced with a competitive market, which also features Novartis IL-17 drug Cosentyx, Lilly embarked on a broad R&D program that positioned it to establish mirikizumab as a late entrant to the psoriasis space and an early mover in gastrointestinal disorders.

The top-line phase 3 results provide partial validation of Lillys big bet on mirikizumab. In LUCENT 1, Lilly set out to compare intravenous mirikizumab to placebo in patients with moderately to severely active ulcerative colitis who had been failed by conventional or biologic therapies.

After 12 weeks, the rate of clinical remission was significantly higher in the mirikizumab arm, causing the trial to hit its primary endpoint with a p-value of less than 0.0001. Subjects were classed as being in clinical remission when the control or resolution of colon inflammation led to the normalization, or near-normalization, of symptoms such as stool frequency and bleeding.

Mirikizumab also beat placebo against all key secondary endpoints including bowel urgency and endoscopic remission with highly statistically significant p-values, Lilly said. Symptoms stopped as early as four weeks after treatment. The responders to mirikizumab included patients failed by JAK inhibitors and biologic therapies.

The top-line readout suggests mirikizumab improves outcomes in ulcerative colitis patients who have exhausted existing treatment options. However, the lack of numbers in the Lilly release make it hard to gauge how big an impact mirikizumab could have on the market.

Lilly plans to disclose the full data in the future but for now is still working to gather evidence on the effects of mirikizumab in ulcerative colitis. A placebo-controlled maintenance study of mirikizumab in patients who have completed the 12-week LUCENT-1 induction is ongoing, as is a long-term efficacy and safety trial. The trials will give Lilly 52-week data on the effects of mirikizumab.

Full results from the studies are expected early next year. The timeline gives Lilly a shot at getting mirikizumab to market in ulcerative colitis before developers of other anti-IL-23 antibodies. AbbVie is running a phase 2/3 trial of Skyrizi in ulcerative colitis but last year delayed the estimated primary completion. ClinicalTrials.gov lists the new primary completion as September 2022. J&Js IL-23 drug Tremfya is in a phase 2/3 ulcerative colitis trial with a primary completion date of June 2022.

Stelara is cleared for use in ulcerative colitis but appears to be less effective than pure IL-23 inhibitors in psoriasis. If Lilly shows pure IL-23 inhibitors have a similar edge over Stelara in ulcerative colitis, it could carve out a piece of the market before facing competition from Skyrizi and Tremfya.

Continued here:
Lilly's Skyrizi rival hits goal in ulcerative colitis phase 3, as it ups the ante against AbbVie - FierceBiotech

The Psoriasis Drug Market is expected to grow at a CAGR of 6.67% and is poised to reach US$XX Billion by 2027 as compared to US$XX Billion in 2020. The factors leading to this extraordinary growth is attributed various market dynamics discussed in the report. Our experts have examined the market from a 360 degree perspective thereby producing a report which is definitely going to impact your business decisions.

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Psoriasis Drug Market Evolving Opportunities with Innovative Ideas by Key Players Pfizer, Bayer, LEO Pharma KSU | The Sentinel Newspaper - KSU | The...

Read on to find out the latest about AbbVie, GBT, a small global biopharma company with a potentially monster drug, and impactful studies from the world of COVID-19 research.

AbbVie Stock Trips Upon FDA Delay of Rinvoq

AbbVie and its investors will have to practice the virtue of patience as the Food and Drug Administration (FDA) extended its review of upadacitinib, or Rinvoq, for the treatment of adults with active psoriatic arthritis.

The top U.S. regulator made the decision to extend the supplemental New Drug Application (sNDA) on Wednesday, requesting further information and an updated benefit-risk profile for this indication. AbbVie will have three months to compile the data, putting the new action date close to the end of Q2 2021.

Rinvoq, an oral, once-daily selective, and reversible JAK inhibitor being studied for the treatment of many immune-mediated inflammatory diseases was approved in 2019 for rheumatoid arthritis.

It is one of two medicines under development that AbbVie investors are betting on to allay the loss when patent protection for Crohn's disease drug, Humira, expires in 2023. Analysts believe that expanded authorization for Rinvoq would go a long way toward that goal.

"We remain confident in the sNDA and are committed to working with the FDA to bring upadacitinib to patients living with psoriatic arthritis and other immune-mediated diseases," said AbbVie vice chairman and president, Michael Severino, M.D.

AbbVies other long-term hopeful to replace the lost revenue from Humira is Skyrizi (risankizumab-rzaa), a treatment for moderate-to-severe plaque psoriasis. AbbVie is teamed up on this one with Boehringer Ingelheim Pharmaceuticals, Inc., and leads the development and commercialization worldwide.

Apellis, the Little Biopharma that Could Transform PNH Treatment

Apellis Pharmaceuticals, a small clinical-stage biopharmaceutical company located in Watertown, Massachusetts, is hoping to leap headfirst into an uphill battle against Alexion Pharmaceuticals soon to beAstraZenecas Soliris and successor, Ultomiris, with its C3 drug for rare paroxysmal nocturnal hemoglobinuria (PNH).

PNH is a rare, acquired life-threatening disorder that occurs when this out-of-control cascade leads to the destruction of red blood cells, blood clots, and impaired bone marrow function.

Systemic Pegcetacoplan (APL-2), which has a PDUFA date of May 14, targets complement proteins centrally at the level of the C3 protein and aims to regulate the uncontrolled or excessive complement cascade that manifests in debilitating diseases in hematology, ophthalmology, nephrology, and neurology.

Swedish Orphan Biovitrum AB, Sobi, holds global co-development and ex-US commercialization rights to Pegcetacoplan.

Soliris (Eculizumab) is a first-in-class C5 complement inhibitor that reduces both the destruction of red blood cells and the need for blood transfusion in patients with PNH.

Yesterday, the New England Journal of Medicine (NEJM) published a comparison of Phase IIIPEGASUS study results of pegcetacoplan comparing the two treatments.

The study demonstrated the superiority of pegcetacoplan in improving hemoglobin levels, along with improvements in key clinical outcomes in adult PNH patients who suffered from persistent anemia after treatment with eculizumab.

The results published in the NEJM state that pegcetacoplan met the studys primary endpoint for efficacy, demonstrating an advantage over eculizumab with a statistically significant improvement in adjusted means of 3.8 g/dL of hemoglobin at week 16 (p<0.001). An impressive 85% of patients were transfusion free at 16 weeks, in contrast to only 15% of eculizumab-treated patients.

Meaningful improvements in fatigue were also noted, all inspiring hope for an improved standard of care in PNH.

The data published in the New England Journal of Medicine underscore the potential of pegcetacoplan to be a significant advancement for people living with PNH, said Peter Hillmen, M.B., Ch.B., Ph.D., professor of experimental hematology at Leeds Teaching Hospitals NHS Trust and PEGASUS study author. There is still a need for new treatments because many patients with PNH treated with C5 inhibitors today remain anemic, resulting in moderate to severe fatigue, with a proportion continuing to require transfusions.

Apellis Chief Medical Officer, Federico Grossi, M.D., Ph.D., also reflected on the results:

The PEGASUS study results demonstrate that, if approved, pegcetacoplan has the potential to elevate the standard of care for PNH by providing more complete disease control. We are working to quickly bring this potential new treatment to PNH patients and to advance development of pegcetacoplan for many other serious, complement-driven diseases.

Getting to The Heart of COVID-19 Fatalities

Further insight is beginning to emerge into COVID-19s most lethal mechanisms of action. The latest? A study showing that three-quarters of people who died from the illness were found to have the SARS-CoV-2 virus in their hearts.

There is a debate surrounding whether heart damage including elevated levels of troponins, inflammation of the sac surrounding the heart, and inflammation of the muscle itself are caused directly by the virus or the overactive immune response it elicits.

The study, published yesterday in Modern Pathology, in which scientists utilized in situ hybridization and NanoString transcriptomic profiling to study the hearts of 41 victims of the virus, revealed its existence in 30 of them.

Unlike the more common real-time polymerase chain reaction (RT-PCR), this approach does not have to make DNA copies first and can identify viral RNA even after it is broken down into smaller pieces. The team also analyzed about 1,000 pieces of heart tissue, which James Stone, a cardiovascular pathologist at Massachusetts General Hospital and contributing scientist, stated is double the amount of most studies.

Stone explained that chemicals used in RT-PCR can break down the RNA, leaving the virus undetectable in tissues.

Despite the intensive study, it is still unclear whether the damage was inflicted by a direct attack on the heart, as most of the cardiac cells affected were immune cells, allowing for the possibility that SARS-CoV-2 could have traveled from another part of the body.

Still, it could help to paint a picture of why the steroid, dexamethasone, is so effective in some patients and thus bring more clarity to the treatment landscape. Stone said that the virus was only found in 50% of patients who were treated with the drug as opposed to 90% who did not enjoy its potential anti-inflammatory benefits.

Could an Old Leprosy Drug Provide New Hope in COVID-19?

An international alliance of scientists is gung-ho on the potential of repurposing leprosy mainstay, clofazimine, as a treatment for COVID-19.

The researchers, from Sanford Burnham Prebys Medical Discovery Institute and the University of Hong Kong published results from a study in Nature on Tuesday showing that clofazimine significantly reduced viral load and shedding in hamsters infected with the SARS-CoV-2 virus.

Clofazimine was also shown to have a synergistic effect when used in combination with Gilead Sciences remdesivir, which is currently FDA approved for hospitalized COVID-19 patients.

Adding to its potential in the global fight against COVID-19, Clofazimine, which is included in the World Health Organizations List of Essential Medicines, is also attractively affordable.

Clofazimine is an ideal candidate for a COVID-19 treatment. It is safe, affordable, easy to make, taken as a pill, and can be made globally available, said study co-senior author, Professor Sumit Chandra, Ph.D., director of the immunity and pathogenesis program at Sanford Burnham Prebys. We hope to test clofazimine in a Phase II clinical trial as soon as possible for people who test positive for COVID-19 but are not hospitalized.

GBT Adds More Punch to Sickle Cell Disease Portfolio

Global Blood Therapeutics (GBT), born in 2011 with the goal of transforming the treatment and care of sickle cell disease, announced Tuesday that it has added two novel small molecules from Sanofi S.A. to its pipeline.

Under the agreement, GBT will hold worldwide in-license rights to the two early-stage research programs, one which is aiming for a novel anti-sickling mechanism, while the other takes a new approach to reduce inflammation and oxidative stress. The two programs are the brainchildren of Sanofis Bioverativ subsidiary.

GBT hopes that the mechanisms, while distinct, may complement its Oxbryta (voxelotor) tablets which are designed to block sickle hemoglobin polymerization, the root cause of sickle cell disease, and won accelerated approval in 2019.

We envision a future in which sickle cell disease is a well-managed condition with the potential for a functional cure in the form of patient-friendly oral therapies. As we work toward this vision and our goal to transform the treatment and care of people living with this devastating disease, we are advancing our robust internal research programs with disease-modifying potential while continually exploring partnership opportunities across a variety of mechanisms, said Jung E. Choi, chief business and strategy officer of GBT. These novel discovery programs represent promising approaches that we believe may have the potential to lead to meaningful improvements for patients.

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ICYMI: A Closer Look at News You Might Have Missed This Week - BioSpace

Dry skin is more common in the winter than in the warmer months. The changes in humidity and temperature at this time of the year can irritate the skin.

Dry skin can affect many people during the winter, and the severity of the symptoms can vary significantly. Various treatments can replenish the moisture of the skin and relieve the symptoms. People can also take certain steps to prevent the skin from becoming dry.

This article looks at dry winter skin in more detail, including its causes, symptoms, prevention, and treatment.

Winter brings changes in humidity and temperature that create perfect conditions for causing dry skin, also known as xerosis.

The outermost layer of the skin is called the epidermis. The thin outer surface of the epidermis is the stratum corneum, also known as the skin barrier.

A combination of lipids and dying or dead skin cells makes up the skin barrier. The skin barrier forms a layer of protection that prevents harmful toxins from entering the body. When the skin barrier sustains damage, the skin appears dry or irritated.

Moisture is essential for the skin barrier to perform well. Research has shown that there is less moisture in the skin during winter than in the summer, as well as fewer lipids in the skin barrier. These differences contribute to dryness and irritation.

During the winter months, people often turn their indoor heating up high, which reduces humidity and affects how much moisture is available to the skin.

At the same time, the cold outdoor weather, harsh winds, and rain can strip the skin of its natural, moisturizing oils.

Taking hot baths or showers can also damage the surface of the skin, leading to dryness, according to the Baylor College of Medicine. Using harsh soaps and rubbing the skin vigorously when drying it can contribute to skin damage.

The level of moisture in the skin also varies with age, gender, ethnicity, and environmental factors. Other medical conditions can also contribute to dry skin.

Dryness that results from damage to the skin barrier during winter can lead to:

People may experience several of these symptoms at the same time. The right treatment should reduce their severity.

Dry and damaged skin needs moisture replenishment. It is best to keep a skin care regimen as simple as possible when treating dry skin. A simple regimen avoids overloading the skin with unnecessary products, such as toners, serums, and heavy makeup.

Using a moisturizer is the best way to rehydrate the epidermis and prevent water loss from the skin. Thick, greasy moisturizers without perfumes are generally the best option. Thinner gels, lotions, and creams can cause stinging when a person uses them on irritated skin.

Moisturizers containing emollients, which include linoleic, linolenic, and lauric acids, can help smooth the surface of the skin. They fill the spaces between skin cells where there has been a loss of moisture.

Humectants in moisturizers help attract moisture to the skin. Examples of humectants include:

Other ingredients, such as lanolin, silicone, and mineral oil, help seal moisture into the skin. They also form a protective barrier to reduce damage from environmental factors.

According to the American Academy of Dermatology Association, it is very important to apply moisturizer as soon as possible after patting the skin dry following a shower or bath. This approach will seal in as much moisture as possible.

When the seasons start to change, people can avoid getting dry winter skin by taking the following steps:

The use of home remedies can improve most cases of dry skin. If they have no effect, a person can contact a healthcare professional, such as a pharmacist, doctor, or dermatologist. These professionals can prescribe the right products or recommend next steps.

Dry winter skin is not an inevitable consequence of the coldest season. Being conscious of the skin barrier and what it needs to stay healthy can help people take the necessary steps to prevent this uncomfortable condition.

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Winter dry skin: Causes, treatment, and more - Medical News Today

DataIntelo has included a latest report on the Global Psoriasis Drug Market into its archive of market research studies. The report is an amalgamation of detailed market overview based on the segmentations, applications, trends and opportunities, mergers and acquisitions, drivers, and restraints. The report showcases the current and forthcoming technical and financial details of the Psoriasis Drug market. The research study attracts attention to a detailed synopsis of the market valuation, revenue estimation, and market statistics. The study on the emerging trends in the global and regional spaces on all the significant components, such as market capacity, cost, price, demand and supply, production, profit, and competitive landscape. The report also explores all the key factors affecting the growth of the global market, consisting of the demand-supply scenario, pricing structure, profit margins, production, and value chain analysis.

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Impact of COVID-19

The report also talks about the impact of the ongoing global crisis i.e., COVID-19 on the Psoriasis Drug market and explains how the future is going to unfold for the global market. Our analysts have researched thoroughly about the effects of the pandemic on the global economy. The outbreak has directly affected production and demand disrupted the demand and supply chain. The report also computes the financial impact on firms and financial markets. DataIntelo has accumulated insights from several delegates of the industry and got involved in the primary and secondary research to offer the clients data & strategies to combat the market challenges during and after the COVID-19 pandemic.

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The market scenario is likely to be fairly competitive. To analyze any market with simplicity the market is fragmented into the following segments:

By Applications:

By Types:

By Regions:

Segmenting the market into smaller components helps in analyzing the dynamics of the market with more clarity. Another key component that is integrated into the report is the regional analysis to assess the global presence of the Psoriasis Drug market. You can also opt for a yearly subscription of all the updates on the Psoriasis Drug market.

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Below is the TOC of the report:

Executive Summary

Assumptions and Acronyms Used

Research Methodology

Psoriasis Drug Market Overview

Global Psoriasis Drug Market Analysis and Forecast by Type

Global Psoriasis Drug Market Analysis and Forecast by Application

Global Psoriasis Drug Market Analysis and Forecast by Sales Channel

Global Psoriasis Drug Market Analysis and Forecast by Region

North America Psoriasis Drug Market Analysis and Forecast

Latin America Psoriasis Drug Market Analysis and Forecast

Europe Psoriasis Drug Market Analysis and Forecast

Asia Pacific Psoriasis Drug Market Analysis and Forecast

Asia Pacific Psoriasis Drug Market Size and Volume Forecast by Application

Middle East & Africa Psoriasis Drug Market Analysis and Forecast

Competition Landscape

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Psoriasis Drug Market 2021 Will Reflect Significant Growth in Future with Size, Share, Growth, and Key Companies Analysis- AbbVie, Johnson &...

PETACH TIKVA, Israel--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced an interview with CEO Dr. Pnina Fishman will air on The RedChip Money Report on the Bloomberg Network in the U.S. on Saturday, March 20th, at 7 p.m. local time in 73M homes across the United States. The RedChip Money Report also airs on Bloomberg International in Europe in 100M homes at 6 pm local time on Sundays.

In the exclusive interview, Dr. Fishman discusses the Companys upcoming milestones, updates on the pipeline of proprietary small molecule drugs addressing inflammatory, cancer and liver diseases.

To view the interview segment, please visit: https://youtu.be/T6ccv539s4I

The RedChip Money Report" delivers insightful commentary on small-cap investing, interviews with Wall Street analysts, financial book reviews, as well as featured interviews with executives of public companies.

About Piclidenoson

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies. It is currently being evaluated in a multinational Phase III study as a treatment for moderate to severe psoriasis and a Phase II U.S. study for the treatment of moderate to severe COVID-19.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, inflammatory disease and COVID-19. The Company's lead drug candidate, Piclidenoson, is currently in a Phase III trial for psoriasis and a Phase II study in the treatment of moderate COVID-19. Can-Fite's liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and successfully achieved its primary endpoint in a Phase II trial for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information please visit: http://www.can-fite.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fites expectations, beliefs or intentions regarding, among other things, market risks and uncertainties, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as believe, expect, intend, plan, may, should or anticipate or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fites authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Can-Fites actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fites actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the impact of the COVID-19 pandemic; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; statements as to the impact of the political and security situation in Israel on our business; and risks and other risk factors detailed in Can-Fites filings with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.

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Can-Fite BioPharma Interview to Air on Bloomberg Television U.S. on the RedChip Money Report - Business Wire

What is Psoriasis?

Psoriasis is a chronic disorder causing red, scaly patches on the skin. It usually occurs on the limbs, trunk, and scalp but can show up on other parts of the body as well. It is not contagious but it can flare up causing the symptoms to get worse. The rash associated with psoriasis goes through cycles of improvement before it gets worse. Psoriasis is usually the result of a problem with the immune system. It is most likely to occur in members of the same family. At times, psoriasis can be disfiguring, uncomfortable, and even painful.

Symptoms of psoriasis appear as red, thickened areas of the skin with silvery scales. It most often appears on the scalp, elbows, knees, legs, arms, genitals, nails, palms, and lower back. The skin usually replaces itself after about a month. When psoriasis is present, the process speeds up and the skin is replaced in 3-4 days causing the skin cells to multiply quickly and accumulate on the surface in silvery scales. Psoriasis comes in many forms. Each differs in severity, duration, location, shape, and pattern of the scales. The most common form, called plaque psoriasis, begins with little red bumps. Gradually these become larger, and scales form.

Unfortunately, there is no cure for psoriasis but there are many different psoriasis treatments available that can clear the symptoms and bring relief. Your doctor may prescribe medications applied directly to the skin. These contain cortisone compounds, synthetic vitamin D analogs, retinoids, tar, or anthralin used to ease the discomfort caused by the skin patches. Other types of treatment include coal tar, Goeckerman treatment, light therapy, ultraviolet light B (UVB), PUVA, methotrexate, cyclosporine, and biologic agents. Controlling triggers that bring on bouts of psoriasis, such as stress, and taking care of your skin will help keep symptoms in control. The goal is to reduce inflammation and to control shedding of the skin. Moisturizing creams and lotions loosen scales and help control itching.

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Psoriasis Specialist - Katy, TX & Cypress, TX: Texas ...