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Oral Apremilast Demonstrated Long-Term Clinical Benefits for Patients with Psoriatic Arthritis
BOUDRY, Switzerland - Monday, October 28th 2013 [ME NewsWire]

Up to 63 percent of patients achieved ACR 20 at week 52, generally consistent with PALACE 1

Clinically meaningful improvements demonstrated in all key manifestations of psoriatic arthritis at week 52

Apremilast demonstrated a consistent safety profile across three long-term PALACE phase III studies of 1493 patients over 52 weeks

Tolerability improved in pooled analysis between weeks 24 and 52

No clinically meaningful changes in laboratory measurements were demonstrated in the pooled analyses

(BUSINESS WIRE)-- Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced results of three long-term (52-week) phase III studies of apremilast, the Company’s first-in-class, oral, targeted inhibitor of phosphodiesterase 4 (PDE4), in psoriatic arthritis at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego. The studies included 52-week efficacy results from PALACE 2 and 3 and 52-week pooled safety data analyses from PALACE 1, 2 and 3, including effects on laboratory measurements.

"Psoriatic arthritis is a debilitating chronic disease requiring long-term treatment,” stated Maurizio Cutolo, M.D., Research Laboratories and Clinical Academic Division of Rheumatology at the University Medical School of Genova, Italy. "The one-year data from the PALACE trials suggest that, with continued treatment, early responses to apremilast are durable over time. Based on the efficacy and safety data to date from phase III studies, apremilast has the potential to offer an additional treatment option for the long-term management of psoriatic arthritis.”

PALACE 2 and PALACE 3: 52-week efficacy data

Three pivotal studies (PALACE 1, 2 and 3) were conducted in patients with active psoriatic arthritis who had prior experience with conventional DMARDs and/or biologics. The long-term (52 weeks) results from PALACE 1 have been previously reported. Today, the long-term results from the two additional pivotal phase III studies (PALACE 2 and PALACE 3) were reported. Consistent with the results from PALACE 1, significantly more patients receiving apremilast 20 mg or 30 mg twice daily (BID) achieved a modified American College of Rheumatology (ACR) 20 response at week 16 (primary endpoint) than did patients taking placebo in both PALACE 2 (placebo, 20%; apremilast 20 mg BID, 38%, P=0.0002; apremilast 30 mg BID, 34%, P=0.0024) and PALACE 3 (placebo, 19%; apremilast 20 mg BID, 29%, P<0.05; apremilast 30 mg BID, 43%, P<0.0001). Clinically meaningful improvements were also demonstrated in signs and symptoms, physical function and other manifestations chartacteristic of psoriatic arthritis, including swollen and tender joints, skin and quality of life.

Sustained improvements in the percentage of patients achieving a modified ACR 20 response at week 52 were observed in both PALACE 2 (apremilast 20 mg BID, 52.9%; apremilast 30 mg BID, 52.6%) and PALACE 3 (apremilast 20 mg BID, 56.0%; apremilast 30 mg BID, 63.0%) for those patients randomized to apremilast and completing 52 weeks of treatment.

PALACE 1, PALACE 2 and PALACE 3: pooled 52-week safety data

Long-term (52 weeks) safety results from a pooled analysis of the PALACE 1, 2 and 3 trials (including 1,493 patients) identified no new safety findings for patients with psoriatic arthritis who were treated with apremilast for up to 52 weeks, compared with the previously reported 24 week safety results. Previously reported adverse events (AEs) were less frequent in weeks 24 to 52 than in weeks 0 to 24.

Most AEs were mild or moderate in severity and did not lead to discontinuation. The most commonly reported AEs were nausea, diarrhea, headache, upper respiratory tract infection and nasopharyngitis. Nausea and diarrhea were predominantly mild in severity, occurred most frequently in the first two weeks of treatment, and often resolved within a month despite continued treatment. Serious AEs occurred at low rates, were comparable across treatment groups and did not increase with long-term apremilast exposure, based on exposure-adjusted incidence rates per 100 subject years.

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