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Efficacy of VX-509 (decernotinib) in combination with a disease-modifying antirheumatic drug in patients with rheumatoid arthritis: clinical and MRI findings
  1. Mark C Genovese1,
  2. Fang Yang2,
  3. Mikkel Østergaard3,
  4. Nils Kinnman2
  1. 1Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA
  2. 2Vertex Pharmaceuticals Incorporated, Boston, Massachusetts, USA
  3. 3Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet—Glostrup, University of Copenhagen, Copenhagen, Denmark
  1. Correspondence to Dr Mark C Genovese, Division of Immunology and Rheumatology, Stanford University, 1000 Welch Road, Suite 203, Palo Alto, CA 94304, USA; genovese{at}stanford.edu

Abstract

Objective To assess early effects on joint structures of VX-509 in combination with stable disease-modifying antirheumatic drug (DMARD) therapy using MRI in adults with rheumatoid arthritis (RA).

Methods This phase II, placebo-controlled, double-blind, dose-ranging study randomised patients with RA and inadequate DMARD response to VX-509 100 mg (n=11), 200 mg (n=10) or 300 mg (n=10) or placebo (n=12) once daily for 12 weeks. Outcome measures included American College of Rheumatology score (ACR20; improvement of ≥20%) and disease activity score (DAS28) using C reactive protein (CRP), and the RA MRI scoring (RAMRIS) system.

Results ACR20 response at week 12 was 63.6%, 60.0% and 60.0% in the VX-509 100-mg, 200-mg and 300-mg groups, respectively, compared with 25.0% in the placebo group. DAS28-CRP scores decreased in a dose-dependent manner with increasing VX-509 doses. Decreases in RAMRIS synovitis scores were significantly different from placebo for all VX-509 doses (p<0.01) and for RAMRIS osteitis scores (p<0.01) for VX-509 300 mg. Treatment was generally well tolerated.

Conclusions VX-509 plus a DMARD reduced the signs and symptoms of RA in patients with an inadequate response to a DMARD alone. MRI responses were detected at week 12. Treatment was generally well tolerated.

Trial registration number NCT01754935; results.

  • Rheumatoid Arthritis
  • Magnetic Resonance Imaging
  • DMARDs (biologic)

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