Celgene's Apremilast Achieves Statistical Significance In Psoriasis Patients

By RTT News, March 02, 2013, 11:29:00 AM EDT

(RTTNews.com) - Celgene International Srl, a part of Celgene Corp. ( CELG ), Saturday presented the results from ESTEEM 1, the company's first phase III study in psoriasis, at the American Academy of Dermatology annual meeting in Miami, Florida.

The company previously announced statistical significance for the primary and major secondary endpoint of PASI-75 at Week 16 and the Static Physician Global Assessment for patients receiving apremilast in the ESTEEM 1&2 phase III studies.

ESTEEM 1&2 are the phase III registrational randomized, placebo-controlled studies evaluating the Company's oral small-molecule inhibitor of phosphodiesterase-4 (PDE4) in patients with moderate-to-severe chronic plaque psoriasis.

ESTEEM 1, presented today, evaluated efficacy and safety in a range of patients. Approximately one-third of the study population was systemic and/or phototherapy treatment-nave. Nearly 30 percent of the overall study population had prior biologic therapy, which included biologic-failures.

In the ESTEEM 1 study, a significantly higher percentage of apremilast-treated patients demonstrated PASI-75 at week 16 than did placebo patients (33.1% vs. 5.3%; P<0.0001).

Significantly higher PASI-75 scores at week 16 were demonstrated across all patient segments enrolled in this study, including systemic-nave and biologic-nave patients receiving apremilast 30 mg BID compared with placebo.

Apremilast demonstrated maintenance of effect over time, as measured by the Mean Percent Change from Baseline in PASI score over 32 weeks, with apremilast demonstrating a 54.9% reduction at week 16 and a 61.9% reduction at week 32.

The overall safety and tolerability profile was consistent with results from previously reported phase III psoriatic arthritis trials. No cases of tuberculosis or lymphoma were observed through week 16, and there was no increased risk of cardiovascular events or serious opportunistic infection. Apremilast was generally well tolerated.

The most common adverse events greater than placebo were diarrhea, nausea and headache. Greater than 96% of patients in the study reported no AEs or mild to moderate AEs.

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Celgene's Apremilast Achieves Statistical Significance In Psoriasis Patients