Peficitinib, a JAK Inhibitor, in Combination With Limited Conventional Synthetic Disease-Modifying Antirheumatic Drugs in the Treatment of Moderate-to-Severe Rheumatoid Arthritis – Genovese – 2017 – Arthritis – Rheumatology – Wiley Online Library #moderate #to #severe #rheumatoid #arthritis

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Peficitinib, a JAK Inhibitor, in Combination With Limited Conventional Synthetic Disease-Modifying Antirheumatic Drugs in the Treatment of Moderate-to-Severe Rheumatoid Arthritis

Authors

Mark C. Genovese ,

Maria Greenwald,

Christine Codding,

Supported by Astellas Pharma Global Development.

Dr. Genovese has received consulting fees, speaking fees, and/or honoraria from Galapagos, Pfizer, Vertex, AbbVie, and Lilly (less than $10,000 each), and Gilead (more than $10,000) and grants from Pfizer, Vertex, AbbVie, Lilly, and Gilead. Dr. Codding has received grants from Genentech, AbbVie, Bristol-Myers Squibb, Novartis, Lilly, Astellas Pharma Global Development, Pfizer, Janssen, Gilead, Celgene, Merck, Mesoblast, Sandoz, Coherus, Sanofi, Daiichi Sankyo, and UCB. Dr. Zubrzycka-Sienkiewicz has received grants from Galapagos NV, Merck Company, Inc. Celltrion, Inc. Roche Holding Ltd, Janssen Biotech Inc. Auven Therapeutics, UCB SA, Mabion, and Astellas Pharma Global Development. Dr. Kivitz has received consulting fees, speaking fees, and/or honoraria from Astellas Pharma Global Development, Eli Lilly and Company, Galapagos NV, and Genentech (less than $10,00 each) and AbbVie, Inc. Johnson Johnson, Pfizer, and Vertex Pharmaceuticals, Inc. (more than $10,000 each). Dr. Cardiel has received consulting fees, speaking fees, and/or honoraria from Pfizer, AbbVie, Roche, and Lilly (less than $10,000 each) and has provided expert testimony on behalf of Roche and Pfizer.

Abstract

Objective

To evaluate the efficacy and safety of orally administered once-daily peficitinib in combination with limited conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in patients with moderate-to-severe rheumatoid arthritis (RA).

Methods

In this randomized, double-blind, phase IIb trial, patients with RA (n = 289) were treated with peficitinib 25 mg, 50 mg, 100 mg, or 150 mg or matching placebo once daily for 12 weeks. The primary end point was the percentage of patients who met the American College of Rheumatology 20% improvement criteria (achieved an ACR20 response) at week 12.

Results

ACR20 response rates at week 12 were 22.0%, 36.8%, 48.3% (P 0.05), 56.3% (P 0.01), and 29.4% in the peficitinib 25 mg, 50 mg, 100 mg, 150 mg, and placebo groups, respectively. Patients in the peficitinib 100 mg and 150 mg groups achieved a rapid and statistically significant ACR20 response compared with those in the placebo group (P 0.05), reaching statistical significance by week 2. Overall, the incidence of adverse events (AEs) was similar between patients receiving peficitinib and those receiving placebo. The most common AEs were upper respiratory tract infection (5% [n = 15]), nausea (4% [n = 12]), and urinary tract infection (4% [n = 10]). There was 1 case of herpes zoster in the placebo group, and 1 serious infection (limb abscess) in the peficitinib 25 mg group. There were no incidences of grade 2 or higher neutropenia or lymphopenia.

Conclusion

In patients with moderate-to-severe RA, orally administered once-daily peficitinib in combination with limited csDMARDs resulted in a dose-dependent ACR20 response rate over 12 weeks with satisfactory tolerability.

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