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Efficacy and safety of pamapimod in patients with active rheumatoid arthritis receiving stable methotrexate therapy
  1. Rieke E Alten (rieke.alten{at}schlosspark-klinik.de)
  1. Schlosspark-Klinik, Internal Medicine, Rheumatology, Teaching Hospital Charite, University Medicine, Germany
    1. Cristiano Zerbini
    1. Hospital Heliopolis, Servico de Reumatologia, São Paulo, Brazil
      1. Slawomir Jeka
      1. NZOZ, Poland
        1. Fedra Irazoque
        1. Servicio de Reumatología, CMN 20 de Noviembre, ISSSTE, México, D. F., Mexico
          1. Faruq Khatib
          1. Clinresco Centres (Pty) Ltd, Arwyp Medical Suites, Kempton Park, South Africa
            1. Paul Emery
            1. Chapel Allerton Hospital, Rheumatology Research Department, Leeds, United Kingdom
              1. Anne Bertasso
              1. Hoffman-La Roche, Nutley, New Jersey, United States
                1. Michael Rabbia
                1. Hoffman-La Roche, Nutley, New Jersey, United States
                  1. John P Caulfield
                  1. Roche Palo Alto, LLC, Palo Alto, California, United States

                    Abstract

                    Objective: To determine the efficacy and safety of pamapimod in adult patients with active rheumatoid arthritis (RA) who had an inadequate clinical response to methotrexate (MTX).

                    Methods Patients receiving stable doses of MTX were randomized to one of six dose groups and received 12 weeks of double-blind pamapimod (up to 300 mg once daily [qd]) or matching placebo. The primary efficacy measure was the proportion of patients with ≥ 20% improvement in RA based on the American College of Rheumatology criteria (ACR20) at 12 weeks. Secondary measures were ACR50, DAS/EULAR response, and individual ACR core set of parameters. Safety measures included adverse events (AEs), laboratory testing, and immunology assessments.

                    Results On a background of MTX, the percentage of patients with an ACR20 response at week 12 in the pamapimod groups (31-43%) was not significantly different from placebo (34%). Secondary efficacy end points showed a similar pattern. AEs were typically mild and included infections, gastrointestinal disturbances, dizziness and rashes; AEs resulting in discontinuation of study drug were primarily attributed to infections.

                    Conclusion: In patients with active RA receiving stable doses of MTX, pamapimod showed non-significant improvement in efficacy outcomes compared to placebo.

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