Oral Apremilast Significantly Improved Nail and Scalp Psoriasis and Health-Related Quality-of-Life Measures in Phase …

BOUDRY, Switzerland--(BUSINESS WIRE)--

Celgene International Srl, a wholly-owned subsidiary of Celgene Corporation (CELG), today announced results of pre-specified sub-analyses from ESTEEM 1 on nail and scalp psoriasis, as well as health-related quality-of-life outcomes, from the Companys first phase III study in psoriasis, at the 22nd Congress of the European Academy of Dermatology and Venereology annual meeting in Istanbul, Turkey.

ESTEEM 1 is the largest of two registrational, randomized, placebo-controlled studies evaluating apremilast, an oral small-molecule specific inhibitor of phosphodiesterase 4 (PDE4), in more than 1,200 patients with moderate-to-severe plaque psoriasis. Previously reported findings from ESTEEM 1 showed that apremilast significantly improved general signs and symptoms of psoriasis across a wide-range of patient types.

Up to 55 percent of patients with psoriasis at any given time have nail involvement, and more than half have scalp psoriasis, which can be particularly debilitating for individuals dealing with this difficult-to-treat disease, said Professor Kristian Reich, M.D., SCIderm Research Institute and Dermatologikum, Hamburg, Germany. These analyses demonstrate that apremilast may improve these conditions and may offer a much-needed new oral treatment option for psoriasis patients. Moreover, the encouraging health-related quality-of-life findings suggest that long-term treatment with oral apremilast may improve the mental and physical well-being of these patients.

New analyses (abstract #2033) assessed the effects of apremilast on 558 patients in ESTEEM 1 with nail psoriasis and on 563 patients with at least moderate scalp psoriasis.

After 16 weeks of treatment, patients in the apremilast 30 mg twice daily (BID) group had significantly greater improvements in the Nail Psoriasis Severity Index (NAPSI) scores than the patients treated with placebo, showing an improvement of 22.5% vs. a worsening of 6.5%, respectively; P

Psoriasis of the scalp, another difficult-to-treat area, was also improved by treatment with apremilast 30 mg BID. After 16 weeks of therapy, significantly more patients treated with apremilast 30 mg achieved a ScPGA score of 0-1 (clear or almost clear) compared with those in the placebo group (46.5% vs. 17.5%, respectively; P

As shown in a separate analysis (abstract #0237), the treatment of 844 patients in ESTEEM 1 with apremilast also significantly improved health-related quality-of-life, as assessed by a variety of standardized measurements, including the Dermatology Quality of Life Index (DLQI), the Patient Health Questionnaire (PHQ-8), the European Quality of Life 5 Dimensions Questionnaire (EQ-5D), and the 36-item Short-Form Health Survey (SF-36) mental component summary (MCS).

Significant improvements in these measurement tools were seen after 16 weeks of treatment with apremilast; improvements were maintained through 32 weeks of treatment. Patients initially treated with placebo for 16 weeks who were then treated with apremilast for a subsequent 16 weeks also showed improvements in these measures.

In these analyses, the overall safety and tolerability profile of apremilast in patients with moderate to severe psoriasis was consistent with previously reported findings. The most commonly observed adverse events included diarrhea, nausea, upper respiratory tract infection, nasopharyngitis, tension headache, and headache. Adverse events were generally mild to moderate in severity. Nausea, vomiting, and diarrhea tended to occur most frequently during the first week of dosing and subsequently decreased. The discontinuation rate due to these AEs was low.

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Oral Apremilast Significantly Improved Nail and Scalp Psoriasis and Health-Related Quality-of-Life Measures in Phase ...