Celgene Announces Will Offer Findings from Long-Term Post-Hoc Analysis of Pooled Data from PALACE Phase III Trial of Otezla at EULAR

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation

, today announced that the findings from a long-term (104-week) post-hoc analysis of pooled data from the PALACE phase III clinical trial program of Otezla® (apremilast) will be presented at the European League Against Rheumatism (EULAR) Annual Congress in Rome, Italy. OTEZLA is the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4) approved for the treatment of adults with active psoriatic arthritis. "Dactylitis and enthesitis are common, painful manifestations of psoriatic arthritis that can be difficult to treat," said Dafna Gladman, M.D., FRCPC, Professor of Medicine, University of Toronto. "Oral OTEZLA can improve these challenging manifestations." Dr. Gladman, the lead investigator of the study, will present the analysis of pooled data from the PALACE 1, 2 and 3 phase III clinical trials in which patients with enthesitis and dactylitis at baseline were allowed to be evaluated for the therapeutic benefit of OTEZLA on enthesitis and dactylitis over 104 weeks. In the PALACE trials, patients were randomized to receive either OTEZLA 20 mg twice daily, OTEZLA 30 mg twice daily or identically appearing placebo for the first 16 weeks. At week 16, some placebo-treated patients were randomized to one of the two OTEZLA groups, while others remained on placebo through week 24. At week 24, patients either continued on OTEZLA or were switched from placebo to OTEZLA 20 mg or 30 mg twice daily in a long term, open-label, active treatment phase. Although enthesitis and dactylitis involvement were not required for patients to enter the study, and patients were not stratified according to baseline enthesitis or dactylitis, approximately 63 percent (945/1,493) of patients had pre-existing enthesitis at baseline and approximately 42 percent (633/1,493) of patients had pre-existing dactylitis at baseline. A post-hoc analysis on the effect of OTEZLA on enthesitis and dactylitis in patients with pre-existing enthesitis or dactylitis was performed on as-observed pooled data from PALACE 1, 2 and 3. The study abstract states that treatment with OTEZLA 30 mg twice daily in patients with pre-existing enthesitis (inflammation at sites where tendons or ligaments insert into bone) or dactylitis (inflammation of an entire digit) — two distinct manifestations of psoriatic arthritis — demonstrated improvements in these symptoms at 52 weeks and that improvements were sustained through week 104. For patients taking OTEZLA 30 mg twice daily, the mean Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) was reduced by 43.5 percent at week 52 (n=377) and by 57.5 percent at week 104 (n=302). A score of 0, indicating no pain at any of the sites assessed, was achieved by 37.7 percent of patients at week 52 and 48.7 percent at week 104. OTEZLA 30 mg twice daily also resulted in a mean 67.9 percent decrease in dactylitis count at week 52 (n=249) and 80.0 percent decrease at week 104 (n=200). A dactylitis count of 0, indicating no signs of dactylitis, was achieved by 67.5 percent of patients at week 52 and 77.5 percent of patients at week 104. During weeks 0 to 52, adverse events (AEs) occurring in at least five percent of patients treated with OTEZLA were diarrhea, nausea, headache, upper respiratory tract infection (URTI) and nasopharyngitis. Rates of URTI, nasopharyngitis, diarrhea, nausea and headache between weeks 52 and 104 were 6.5 percent, 5.8 percent, 2.9 percent, 1.8 percent and 3.0 percent, respectively. No new safety concerns were identified, and no increases were seen in AE incidence or severity with longer exposure.