Daily Archives: February 9, 2024

A New Hope in the Treatment of Plaque Psoriasis

A recent study published in the New England Journal of Medicine has shed light on a potentially effective treatment for moderate-to-severe plaque psoriasis. The study investigated the efficacy of JNJ-77242113, a novel interleukin-23-receptor antagonist peptide developed by Janssen Research and Development. The results offer promising implications for patients suffering from this chronic skin condition.

The study involved a total of 255 patients with moderate-to-severe plaque psoriasis. These patients were randomly assigned to receive various doses of JNJ-77242113 or a placebo over a course of 16 weeks. The primary endpoint of the study was to observe a reduction of at least 75% in the Psoriasis Area and Severity Index (PASI) score at week 16. This score is a widely accepted measure for the severity of psoriasis.

The study demonstrated that JNJ-77242113 showed greater efficacy than the placebo, with a significant dose-response relationship observed. This means that as the dosage of JNJ-77242113 increased, the reduction in PASI score also increased significantly. Specifically, in the highest dose group tested of 100 mg twice daily, 79% of patients achieved a PASI 75 response. This is indeed a promising result for a phase 2 trial.

As with any clinical trial, understanding the safety profile and potential adverse events of the tested drug is critical. The most common adverse events reported during this study were COVID-19 and nasopharyngitis, also known as the common cold. However, its important to note that the percentage of patients with at least one adverse event was similar in both the combined JNJ-77242113 dose group and the placebo group, suggesting that the drug may have a comparable safety profile to the placebo.

JNJ-77242113 is an orally administered peptide that selectively blocks interleukin-23 signaling and downstream cytokine production. The role of interleukin-23 in the body is to regulate inflammatory responses and immune system function. By blocking its signaling, JNJ-77242113 can potentially control the overactive immune responses seen in psoriasis, thereby reducing inflammation and the severity of the condition.

Following the positive results from the phase 2 trial, Johnson & Johnson has initiated the pivotal Phase 3 ICONIC clinical development program of JNJ-77242113 in adult and adolescent patients with moderate to severe plaque psoriasis. This next phase will further evaluate the drugs efficacy and safety profile in a larger patient population.

The phase 2 trial results for JNJ-77242113 are indeed encouraging. With its potential efficacy and favorable safety profile, JNJ-77242113 could soon offer a new, effective oral treatment option for patients suffering from moderate-to-severe plaque psoriasis. As we await further results from the Phase 3 trial, the current findings certainly provide a beacon of hope for those affected by this chronic skin condition.

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New Hope in Treatment of Plaque Psoriasis: Study Shows Promising Results - Medriva

There is a high level of similarity in ex-vivo cellular immune responses among moderate-to-severe chronic plaque psoriasis patients, regardless of exclusively receiving reference product adalimumab (Humira) or switching between adalimumab and AVT02, according to new findings.1

These findings represent the conclusion of an analysis of ex vivo exploratory data drawn from a comparative clinical trial. The trial had been conducted to look into the interchangeability between monoclonal antibody AVT02 and the reference product.

This was led by Kathleen Richter, from Alvotech Germany GmbH in Jlich, Germany. Richter and colleagues noted the prior confirmation of AVT02s biosimilarity to adalimumab in a pharmacokinetic study and then in follow-up research confirming safety and efficacy.2,3

The aim was to compare the cell-mediated immunogenicity in participants with moderate-to-severe chronic plaque psoriasis in the AVT02-GL-302 study who received either the RP alone or switched between the RPand AVT02 after ex vivo exposure of isolated PBMCs with the reference product, AVT02, or Keyhole limpet hemocyanin (KLH), using the novel ex vivo comparative immunogenicity assessment (EVCIA), Richter and colleagues wrote.

During the AVT02-GL-302 study, the investigators carried out an ex vivo comparative immunogenicity assessment (EVCIA) to determine cellular immunogenicity among subjects of the study that had chronic cases of psoriasis. The subjects were randomly assigned using a 1:1 ratio by week 12 to be part of the non-switching cohort (given the reference product) or the switching cohort (alternating between adalimumab and AVT02).

The research team gathered peripheral blood mononuclear cells (PBMCs) and they cryopreserved the cells at the week 1 point of baseline, at the week 12 pre-randomization period, and at weeks 16 and 28 among both cohorts. By the time the team began thawing, the cells were re-exposed to several different types of stimuli, some of which included medium alone (negative control), AVT02, reference product, keyhole limpet hemocyanin (KLH) (positive control), RP+KLH, or AVT02+KLH.

The investigators then assessed cytokine release and Th-cell proliferation through the samples collected from 10 subjects per arm. The team thereby ensured a predetermined average cell viability of 75% over all of the different points in time.

The research team found that the cytokine release and Th-cell proliferation continued to be comparable at each of the different points in time between the group that switched and the group that did not switch until the 28-week mark. A notable finding was that in all time points, the overall cellular immune response ended up being heightened post-KLH re-exposure.

This research, which had been derived from the AVT02-GL-302 study, was shown by the team to have reinforced the confirmation of interchangeability seen in the main trial. This may allow for helpful data on the effects of switching treatments on patients cellular immunogenicity.

The innovative EVCIA methodology employed by the investigators in their research here may provide a distinct assessment of both qualitative and quantitative shifts occurring in the cellular immunogenic response caused by switching conditions in vivo.

Initial cellular response could be a valuable additional outcome to predict overall immune response to biologic medicines, currently typically measured by the later development of ADAs and Nabs, they concluded.

The investigators also noted the importance of interpreting the results and considering the research limitations. They noted that the rapid treatment of blood samples was important due to EVCIA sensitivity, adding that delays could impact cell responses and data quality.

In addition, the research team acknowledged that additional confirmation may be needed as the studys small sample sizes and analysis do not have the same needs as larger, prospective, randomized clinical trials.

References

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No Difference in Psoriasis Immune Response Despite Switch Between AVT02, Adalimumab - MD Magazine

Robert Bissonnette, MD

Credit: International Psoriasis Council

Once and twice-daily oral administration of interleukin (IL)-23receptor antagonist peptide JNJ-77242113 met its primary endpoint of achieving a Psoriasis Area and Severity Index (PASI) score reduction of at least 75% or greater among those with moderate-to-severe plaque psoriasis, according to new findings.1

These findings were the results of a study published in The New England Journal of Medicine, conducted with the aim of assessing the performance of JNJ-77242113 as an oral drug. The studys investigators noted the value of effective oral treatment options, as apremilast is known to be only moderately-effective compared to biologics.2

This new research was led by Robert Bissonnette, MD, dermatologist and president of Innovaderm Research Inc. in Montral.

The science behind advanced treatments for immune-mediated inflammatory diseases like PsO has advanced over the last few decades and patients desire treatment options that combine standard of care efficacy, an acceptable safety profile and flexible routes of administration, said Robert Bissonnette, MD, chief executive officer and medical director at Innovaderm Research, Montreal, Canada.3 The Phase 2b FRONTIER 1 data, as reported in NEJM, are very encouraging for the ongoing clinical development program and offer a reason to look forward to the continued research of investigational JNJ-2113 as an oral therapy that may offer an attractive and convenient treatment option for patients.

The study, known as the FRONTIER 1 trial, was led by Janssen Research and Development in collaboration with external medical experts. The research team looked into the efficacy of JNJ-77242113 versus placebo in adult individuals 18 years of age and older that had diagnoses of moderate-to-severe plaque psoriasis.

The trial design, data analysis, treatment administration, and manuscript formation involved the input and participation of the investigators. Individuals deemed to be eligible as subjects met specific criteria, including a diagnosis of psoriasis at minimum a half a year beforehand and suitability for phototherapy or systemic therapy.

Patients were excluded if they had non-plaque or drug-induced psoriasis, or had previously received certain biologic treatments. Enrollment occurred across 60 sites globally, with the trial being a phase 2, double-blind, randomized, placebo-controlled study.

The investigators randomized the participants to distinct doses of JNJ-77242113 or placebo for 16 total weeks, with the groups being given 25 mg once or twice-per-day, 50 mg once-per-day, 100 mg once, or 100 mg twice-per-day.

The research team determined their main endpoint to be a reduction of 75% or more in subjects PASI score from the point of baseline at the 16-week mark. After completion, the participants were given the option to take part in a long-term extension phase known as FRONTIER 2 or to be given their final safety follow-up.

Among their secondary endpoints, the team looked at Dermatology Life Quality Index (DLQI) and Psoriasis Symptoms and Signs Diary (PSSD) scores. The investigators also noted that concomitant treatments had been restricted during the trial period.

The research team ended up randomizing a total of 255 subjects, noting that there was a mean PASI score of 19.1 at the point of baseline. The team also found that the participants average duration of their psoriasis was shown to be 18.2 years, adding that 78% of those featured in all trial cohorts had had previous systemic therapy.

PASI 75 response rates at the 16-week mark were shown to be substantially higher in JNJ-77242113-treated groups. They reported rates of 37%, 51%, 58%, 65%, and 79% for 25-mg once-daily, 25-mg twice-daily, 50-mg once-daily, 100-mg once-daily, and 100-mg twice-daily groups versus 9% for placebo, respectively.

These results demonstrated a substantial doseresponse relationship (P<0.001). The investigators did find that adverse events included coronavirus disease 2019 for 12% of those in the placebo group and 11% in each of the JNJ-77242113 groups.

Additionally, the team noted that nasopharyngitis (among 5% and 7%, respectively) was an adverse event reported by subjects. They did add, however, that there was not evidence of a dose-related adverse event increase among those treated with the drug, as incidence of was comparable between each of the JNJ-77242113 dose groups (52%) and the placebo (51%).

In this phase 2 trial, JNJ-77242113showed a doseresponse relationship and greater efficacy than placebo, as measured by the PASI 75 response at week 16, in patients with moderate-to-severe plaque psoriasis, they wrote. Overall, there was no evidence of a relationship between the JNJ-77242113 dose and the incidence of adverse events.

References

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Oral IL-23 Receptor Antagonist Peptide Effective in PASI Reduction for Psoriasis - MD Magazine

A Breakthrough in Psoriasis Treatment

Plaque psoriasis, a chronic skin condition characterized by patches of abnormal skin, often brings about significant discomfort and distress to those affected. The search for an effective treatment has led to a promising discovery: JNJ-77242113, an interleukin-23-receptor antagonist peptide. According to a study published in the New England Journal of Medicine, this innovative oral medication has shown greater efficacy than a placebo in patients suffering from moderate-to-severe plaque psoriasis.

The phase 2 dose-finding trial involved 255 patients and revealed a significant dose-response relationship. This means that higher doses of JNJ-77242113 resulted in a greater therapeutic effect. Remarkably, a higher percentage of patients receiving JNJ-77242113 showed a Psoriasis Area and Severity Index (PASI) 75 response compared to those in the placebo group. PASI 75 response refers to a 75% reduction in the PASI score, a tool used to measure the severity and extent of psoriasis. This achievement serves as the primary endpoint of the trial, marking a significant milestone in psoriasis treatment.

The potency of JNJ-77242113 was clearly demonstrated, with 79 percent of patients in the highest dose group achieving a PASI 75 response at Week 16. This impressive result signals a potential game-changer for those battling moderate to severe plaque psoriasis. Furthermore, the study found no evidence of a dose-related increase in adverse events across the JNJ-77242113 dose groups, suggesting that even at higher doses, the treatment maintains a favourable safety profile.

The most common adverse events reported during the trial were COVID-19 and nasopharyngitis, a common infection resulting in inflammation of the nasal passages and throat. Its important to note that similar percentages of patients experienced adverse events in both the JNJ-77242113 and placebo groups. The occurrence of these events is not surprising given the ongoing COVID-19 pandemic and the common nature of nasopharyngitis.

The positive results from this phase 2 trial have spurred further research and development. Janssen Research and Development, the company behind JNJ-77242113, has initiated the Phase 3 ICONIC clinical development program. This program, which includes two studies, aims to further assess the efficacy and safety of JNJ-77242113 in adults and adolescents suffering from moderate to severe plaque psoriasis.

Overall, the results of this study are promising. The development and successful trial of JNJ-77242113 mark a significant advancement in the treatment of moderate-to-severe plaque psoriasis. With ongoing research, there is hope that this medication may revolutionize treatment options and bring much-needed relief to those affected by this often debilitating skin condition.

The rest is here:
Breakthrough in Psoriasis Treatment: JNJ-77242113 Shows Promising Results - Medriva

Plaque psoriasis, a chronic autoimmune condition that results in thick, patchy, red skin, affects millions of people worldwide. The search for more effective, targeted treatments is ongoing. Recently, a prospective phase II trial for an oral interleukin (IL)-23 inhibitor, JNJ-77242113, has shown promising results for moderate-to-severe plaque psoriasis patients.

The study revealed response rates as high as 79% at 16 weeks for JNJ-77242113, significantly higher than the placebo response rate of 9%. The drug achieved response rates of 37% to 79% across five dose levels, and there was no evidence of a dose-related increase in adverse events.

Adverse events included COVID-19 and nasopharyngitis, with the most common occurrences being COVID-19, nasopharyngitis, and diarrhea. However, the incidence of serious adverse events across all dose groups was low, at 1%.

The study suggested that the drugs effectiveness could be influenced by body weight and required to be taken on an empty stomach. More extensive trials are needed to confirm these results and determine the optimal dosage for different body weights and health conditions.

The study also indicated a significant increase in Psoriasis Area and Severity Index (PASI) 75 rates across the five doses of JNJ-77242113 versus placebo. Similar response patterns were seen for PASI 90 and PASI 100, which measure the severity of psoriasis symptoms.

Patients on JNJ-77242113 showed improvements in disease-related symptoms and quality of life outcomes. This is particularly important as psoriasis can significantly impact a persons quality of life, causing physical discomfort and emotional distress.

Following the positive results from the Phase 2b trial, Janssen has initiated the pivotal Phase 3 ICONIC clinical development program for JNJ-2113 in adult and adolescent patients. This next phase will provide more extensive data and confirm the safety and efficacy of this promising new treatment.

Compared to injectable biologics, the oral IL-23 inhibitor JNJ-77242113 showed a similar PASI 90 response rate of 60% at 16 weeks. This suggests that oral therapies could provide a viable alternative to injectables, offering greater flexibility and convenience for patients.

The positive results from the Phase II trial of JNJ-77242113 demonstrate significant progress in psoriasis treatment. The development of oral therapies like JNJ-77242113 and deucravacitinib, which has shown effectiveness and safety in real-world clinical practice in Japan, suggest a promising future for psoriasis treatment, marked by greater flexibility, convenience, and effectiveness.

While larger trials are needed to confirm these findings, the current studies provide hope for people living with moderate-to-severe plaque psoriasis, a condition that until now has had limited treatment options.

Excerpt from:
Promising Results from Phase II Trial of Oral Interleukin Inhibitor for Psoriasis Treatment - Medriva

Introduction to the FRONTIER 1 Trial

The FRONTIER 1 trial has recently revealed exciting news for patients suffering from moderate-to-severe plaque psoriasis. The study focused on the efficacy of the oral interleukin-23receptor antagonist peptide, JNJ-77242113. The results demonstrated a clear dose-response relationship, with the compound proving more effective than a placebo within a 16-week timeframe. This article will delve into the details of the FRONTIER 1 trial, its results, and what they mean for the future of psoriasis treatment.

JNJ-77242113 is the first and only targeted oral peptide that selectively blocks the IL-23 receptor. It has shown positive results in a Phase 2b study for moderate-to-severe plaque psoriasis, achieving the primary and all secondary endpoints. These endpoints included PASI 100 and IGA 0 responses of 40.5 percent and 45.2 percent respectively. The study showed a significant dose response on PASI 75 at Week 16 for adult patients who received JNJ-77242113 compared to patients treated with placebo. This makes it a promising candidate for future oral therapies that may offer an attractive and convenient treatment option for patients.

The drug JNJ 77242113 showed high response rates of 37 to 79 in moderate-to-severe plaque psoriasis in the FRONTIER 1 phase II trial. Patients treated with a placebo had a 9% response rate at 16 weeks. The most common adverse events were COVID 19 and nasopharyngitis. However, promising progress was shown in the treatment of moderate-to-severe psoriasis. The percentage of patients who had a PASI 90 response with JNJ 77242113 100 mg twice daily at week 16 was 60%. Despite these positive results, two occurrences of infection and a suicide attempt were reported as serious adverse events, indicating the necessity for larger trials to determine the cause of these events and the effectiveness of JNJ 77242113 in real-world settings.

The Phase II trial results of JNJ-77242113 have instigated the pivotal Phase 3 ICONIC clinical development program. This program aims to confirm the safety and efficacy of this promising new treatment in adult and adolescent patients. In comparison to injectable biologics, JNJ-77242113 showed a similar PASI 90 response rate of 60% at 16 weeks. This suggests that oral therapies could provide a viable alternative to injectables, offering greater flexibility, convenience, and effectiveness. Other oral therapies, like deucravacitinib, are also under development and show promise in revolutionizing psoriasis treatment.

The future of psoriasis treatment looks promising, particularly with the development of oral therapies such as JNJ-77242113. The results of the FRONTIER 1 trial offer a beacon of hope for patients dealing with moderate-to-severe plaque psoriasis. As we anticipate the results of the ICONIC clinical development program, the potential benefits of introducing an oral route of medication administration for patients with psoriasis is an exciting prospect. As research continues, the goal remains to provide safe, effective, and convenient treatment options for all psoriasis patients.

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Promising Results from the FRONTIER 1 Trial - An Exploration of JNJ-77242113 in the Treatment of Moderate-to ... - Medriva

Personal Experience with Psoriatic Arthritis

Maarten de Wit, diagnosed with Psoriatic Arthritis (PsA) during his teenage years, has firsthand experience of the difficulties involved in diagnosing PsA, especially in younger patients. PsA is a chronic inflammatory disease primarily characterized by plaque psoriasis but also has less common variants. It can lead to various comorbidities such as metabolic syndrome, cardiovascular disease, and mental health disorders. Despite the prevalence of PsA, affecting approximately 3% of the US population and causing an estimated healthcare expenditure of over 35 billion annually, its diagnosis is often complex and challenging.

To combat these challenges, the HIPPOCRATES project aims to improve PsA detection and prevent its onset. Similarly, the BIOMAP project seeks to understand and classify PsA and Atopic Dermatitis (AD) subtypes. Both projects utilize advanced molecular techniques in their pursuit of developing more effective treatments.

Atopic Dermatitis (AD) is another skin condition that requires attention, with numerous studies and articles discussing its treatment strategies, patient management, and potential therapeutic avenues. While conventional treatment methods have shown efficacy, managing patients with AD remains a challenge due to varying patient responses and the complex nature of the disease.

Genomic testing in dermatology is emerging as a promising approach to improve medical diagnoses and treatment. It explores the entire genome, including genetic and epigenetic factors, and has made significant advancements in analyzing skin microbiome and mutational analyses of inherited skin diseases. Genomic tests have emerged for various skin conditions like pigmented lesions, melanoma, and cutaneous squamous cell carcinoma and have also expanded into inflammatory skin diseases, offering insights through tape strips for AD and psoriasis.

Recent research has pointed towards a strong connection between gut health and dermatological diseases. The gut microbiome, consisting of over 1014 microorganisms, plays a significant role in human health. Dysbiosis, or imbalance in the gut microbiome, has been strongly associated with AD, psoriasis, acne, and alopecia areata. This has led to the examination of probiotics to correct gut microbiome dysbiosis as a potential treatment avenue for skin diseases.

While the diagnosis and treatment of PsA and AD continue to pose challenges, advancements in molecular techniques, genomic testing, and understanding the role of gut health in skin diseases are paving the way for more accurate diagnosis and effective treatment strategies. Initiatives like the HIPPOCRATES and BIOMAP projects are making strides in understanding these diseases at a molecular level, bringing hope for patients suffering from these conditions.

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Personal Experience with Psoriatic Arthritis and Atopic Dermatitis - Medriva

Stelara, a top-selling psoriasis drug by Johnson & Johnson (@JNJNews), has seen a consistent price increase since its introduction to the market. Since 2012, the drugs price has increased by at least 4.8% annually, leading to an overall price rise of 184%. This escalating cost has raised serious concerns about the drugs affordability for patients. The issue has been a hot topic of discussion among the Health, Education, Labor, and Pensions (HELP) Committee Democrats (@HELPCmteDems) and the GOP HELP Committee (@GOPHELP).

According to data from Simply Wall St, Johnson & Johnsons stock price, market cap, and recent performance are highlighted. The report also includes insights from equity analysts on the companys drug pipeline and revenue growth. Despite being a significant player in the pharmaceutical industry, JNJ has underperformed in the US Pharmaceuticals industry and the US Market over the past year. The Consumer Health segment of the company is also profiled on the site.

Despite the underperformance in certain sectors, Johnson & Johnson announced a strong finish to 2023. As reported on Investing.com, their fourth-quarter worldwide sales reached $21.4 billion, marking a 7.2% increase. The companys quarterly results just slightly exceeded Wall Street expectations.

The consistent price increase of Stelara has been a cause for concern among patients and healthcare advocates. Psoriasis is a chronic condition, and many patients require long-term medication such as Stelara to manage their symptoms. The significant increase in the drugs price puts a financial burden on patients, particularly those without comprehensive medical insurance.

The HELP Committee Democrats and the GOP HELP Committee have been engaged in discussions about the rising cost of Stelara. The committees are concerned about the impact of the price increase on patients and are exploring potential solutions to address this issue. While these discussions are ongoing, it is clear that the rising cost of Stelara is an issue that requires immediate attention.

The rising cost of medication is a pressing issue that affects patient accessibility to necessary treatments. For chronic conditions like psoriasis, the affordability of long-term medication is crucial. As discussions continue among various stakeholders, it is hoped that effective solutions will be found to ensure that patients can access and afford the medication they need.

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Rising Cost of Stelara: Impact on Patients and Johnson & Johnson's Market Performance - Medriva

Psoriatic Arthritis (PsA) Treatment Market

The global psoriatic arthritis (PsA) treatment market is poised for significant expansion, with Future Market Insights, a leading pharmaceutical entity, at the forefront of innovation. According to recent projections, the PsA treatment industry, valued at over US$ 10.3 billion in 2022, is expected to soar to US$ 15.6 billion by 2028, representing a robust compound annual growth rate (CAGR) of 7.1%.

Psoriatic arthritis, a chronic autoimmune disorder often accompanied by psoriasis, poses substantial challenges for patients and healthcare providers alike. However, recent advancements in medical research have paved the way for transformative treatments targeting the underlying immunological dysfunction and inflammation associated with PsA.

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Among these breakthroughs are small molecule targeted therapies, such as Janus kinase (JAK) inhibitors, which have demonstrated promising efficacy in managing PsA symptoms by interfering with specific inflammatory pathways. These medications offer patients alternative options for controlling their condition and improving their quality of life.

Future Market Insights remains committed to driving innovation in the field of PsA treatment, said Sabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.). We recognize the urgent need for effective therapies that address the complex nature of this debilitating condition. Through ongoing research and development efforts, we aim to provide healthcare professionals and patients with advanced treatment options that offer tangible clinical benefits.

The burgeoning demand for PsA treatments reflects both the growing prevalence of the condition and increasing awareness among patients and healthcare professionals. As the market continues to evolve, Future Market Insights is dedicated to leveraging its expertise and resources to deliver innovative solutions that address the unmet needs of individuals living with PsA.

Key Takeaways Psoriatic Arthritis (PsA) Treatment Market:

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Future Market Insights, Inc. (ESOMAR certified, recipient of the Stevie Award, and a member of the Greater New York Chamber of Commerce) offers profound insights into the driving factors that are boosting demand in the market. FMI stands as the leading global provider of market intelligence, advisory services, consulting, and events for the Packaging, Food and Beverage, Consumer Technology, Healthcare, Industrial, and Chemicals markets. With a vast team of over 5000 analysts worldwide, FMI provides global, regional, and local expertise on diverse domains and industry trends across more than 110 countries.

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Global Psoriatic Arthritis (PsA) Treatment Market to achieve a remarkable US$ 15.6 Billion by 2028, - PharmiWeb.com