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Janssen issued results from a phase III trial of STELARA (ustekinumab) for active psoriatic arthritis. Patients were naïve to treatment with anti-TNF-alpha therapies and/or IL-12/23 inhibitors. This multicenter, randomized, double-blind, placebo-controlled study enrolled 615 subjects who had at least five tender and five swollen joints and C-reactive protein (CRP) levels of at least 0.3mg/dL (upper limit of normal [ULN] 1.0 mg/dL) despite treatment with disease-modifying antirheumatic drugs (DMARDs) and/or nonsteroidal anti-inflammatory drugs (NSAIDs). Patients were randomized to receive subcutaneous STELARA 45mg or 90mg or placebo at weeks zero, four and then every 12 weeks. By week 24, all patients receiving placebo were crossed over to receive STELARA. At week 24, 42.4% and 49.5% of patients receiving STELARA 45mg and 90mg, respectively, achieved at least 20% improvement in signs and symptoms, according to the American College of Rheumatology criteria (ACR 20), the primary endpoint, compared with 22.8% of patients receiving placebo (P < 0.0001 for both comparisons). Improvement in signs and symptoms continued to increase after week 24, with 55.7% and 60.3% of patients in the STELARA 45mg and STELARA 90mg groups, respectively, demonstrating ACR 20 response at week 52. Janssen is seeking approval of STELARA in the U.S. and Europe.
Celgene International reported results from a phase III trial of apremilast for the treatment of psoriatic arthritis. This multi-center, double-blind, placebo-controlled, parallel-group study enrolled over 500 patients with psoriatic arthritis. Subjects received apremilast 20mg or 30mg twice daily, or placebo, for 24 weeks, with a subsequent extension in which all patients are treated with apremilast. Data demonstrated statistical significance was achieved for the primary endpoint of ACR 20 at week 16 for patients receiving apremilast 20mg and 30mg. Patients on apremilast also achieved a statistically significant benefit over placebo in key secondary endpoints: various measures of physical function and signs and symptoms. The drug was well tolerated. The most frequent adverse events were nausea, diarrhea and headache. Based on this data, Celgene expects to file a separate NDA in the U.S. for psoriasis and a combined PsA/psoriasis MAA submission in Europe in the second half of 2013.
UCB issued results from a phase III trial of certolizumab pegol for psoriatic arthritis. This global, 48 week, double-blind, parallel-group trial, RAPID-PsA, enrolled 409 subjects with adult onset active psoriatic arthritis. The subjects received certolizumab pegol (200 mg every two weeks or 400 mg every four weeks) or placebo. Data demonstrated a clinically relevant and statistically significant improvement at week 12 in the signs and symptoms of psoriatic arthritis. The treatment was well tolerated and adverse events were consistent with those seen in other trials of certolizumab pegol
Celgene released positive results from a phase II trial of apremilast for the treatment of psoriatic arthritis. This multi-center, randomized, double-blind, placebo-controlled, three-arm study enrolled 204 subjects who received apremilast 20mg twice per day, apremilast 40mg once per day or placebo for 12 weeks. The primary endpoint was the achievement of ACR20, defined as the percentage of subjects attaining a 20% or better improvement according to the American College of Rheumatology (ACR) criteria. Both apremilast treatment arms had a significant improvement in the ACR20 outcome versus placebo at 12 weeks. In the 20 mg twice daily arm and the 40 mg once daily arm, 43.5% and 35.8% of subjects reached ACR20, respectively, compared to 11.8% of subjects in the placebo arm. ACR50 and ACR70 responses were also measured. The 12-week ACR50 was 17.4% in the 20mg twice daily arm, 13.4% in the 40 mg once daily arm and 2.9% in the placebo arm. The 12-week ACR70 was 5.8% in the 20 mg twice daily arm, 7.5% in the 40 mg once daily arm and 1.5% in the placebo arm. Treatment was generally well tolerated.
Cypress and Forest issued positive composite responder results two phase III trials of milnacipran for the treatment of fibromyalgia. Study MLN-MD-02 was a double-blind, placebo-controlled design and enrolled 1,196 subjects who were randomized to receive either milnacipran 100 mg/day, 200 mg/day or placebo over a three-month period. Study FMS-031 was a double-blind, placebo-controlled trial and enrolled 888 subjects who were randomized to receive either milnacipran 100 mg/day, 200 mg/day or placebo for six months To be considered a responder for the composite "pain of fibromyalgia" endpoint, each subject had to demonstrate concurrent and clinically meaningful improvements in two validated measures: pain and global impression of disease status. Pain composite responders were defined as individuals who achieved both a greater than or equal to 30% reduction in pain from baseline and who rated themselves as "very much improved" or "much improved" on a Patient Global Impression of Change (PGIC) scale. To be considered a composite responder for the "treatment of the fibromyalgia syndrome" endpoint subjects had to demonstrate improvement in a third validated measure: physical function. Fibromyalgia syndrome composite responders needed to satisfy the pain composite criteria as well as demonstrate at least a 6-point improvement in their SF-36 physical component summary (SF-36 PCS) score. In study MLN-MD-02 there were 713 evaluable subjects for the fibromyalgia syndrome and pain analyses. In study FMS-031 there were 488 evaluable subjects for the fibromyalgia syndrome analysis and 491 evaluable subjects for the fibromyalgia pain analysis. A statistically significant number of subjects treated with milnacipran during Study MLN-MD-02 met the composite syndrome responder criteria: 25% and 26% for the milnacipran 100 mg and 200 mg groups compared to 13% for placebo. A statistically significant number of subjects treated with milnacipran during Study FMS-031 met the composite syndrome responder criteria at six months: 33% and 32% for the milnacipran 100 mg and 200 mg groups, respectively, compared to 19% for placebo. The composite pain responder criteria for fibromyalgia pain also reached statistical significance during Study MLN-MD-02: 39% and 46% in the milnacipran 100 mg and 200 mg groups, respectively compared to 25% for placebo. A statistically significant number of subjects treated with milnacipran during Study FMS-031 also met these criteria at six months: 44% and 45% of subjects in the milnacipran 100 mg and 200 mg groups, respectively, compared to 28% for placebo. Based on positive phase III results, Cypress and Forest planned to file an NDA around the end of 2007.
Schering Plough and Centocor reported positive results from a phase III trial of golimumab for the treatment of psoriatic arthritis. This study, dubbed GO-REVEAL (Golimumab - A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody), enrolled 405 adult subjects with psoriatic arthritis. The subjects were randomized to receive subcutaneous (SC) injections of placebo or golimumab (50 or 100 mg) at weeks zero, four, eight, twelve, sixteen and twenty. At week sixteen, subjects with inadequate arthritis response were switched to golimumab 50 mg (those originally receiving placebo) or golimumab 100 mg (those originally receiving golimumab 50 mg). The primary endpoint was at least a 20 percent improvement in arthritis signs and symptoms (ACR 20) response at week fourteen for combined golimumab groups and individual golimumab dose groups versus placebo. At week fourteen, 51% of subjects receiving golimumab 50 mg and 45% of subjects receiving golimumab 100 mg experienced ACR 20 compared with 9% of subjects receiving placebo (p less than 0.001). These improvements were maintained through week twenty-four, with 52% and 61% of subjects receiving golimumab 50 mg and golimumab 100 mg, respectively, reaching ACR 20, compared with 12% of subjects receiving placebo (p less than 0.001). Significant improvements were observed in other key endpoints including ACR 50 and ACR 70 and improvements in enthesitis and dactylitis ((p less than 0.001). Among a subset of subjects with at least three percent of body surface area involved by psoriasis at baseline, 40% and 58% of subjects in the golimumab 50 mg and golimumab 100 mg, respectively, achieved PASI 75 at week fourteen, compared with 3% of subjects receiving placebo (P less than 0.001). At week twenty-four, PASI 75 improved to 56% and 66% (golimumab 50 mg and 100 mg, respectively) compared with 1% for placebo (p less than 0.001). In addition, the subjects were classified as good or moderate responders as measured by the Disease Activity Score 28 (DAS28). At week fourteen, 66% and 67% of subjects in the golimumab 50 mg and 100 mg arms, respectively, were DAS28 responders, compared with 24% of subjects in the placebo arm (p less than 0.001). At week twenty-four, this improved to 64% and 78% for golimumab 50 mg and 100 mg, respectively, compared with 24% for the placebo group (p less than 0.001). Additional phase III trials are ongoing at this time.