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Efficacy and safety of pamapimod in patients with active rheumatoid arthritis receiving stable methotrexate therapy
1Schlosspark-Klinik, Internal Medicine, Rheumatology, Teaching Hospital Charite, University Medicine, Berlin, Germany. rieke.alten@schlosspark-klinik.de
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 randomised to one of six dose groups and received 12 weeks of double-blind pamapimod (up to 300 mg once daily) or matching placebo. The primary efficacy measure was the proportion of patients with > or =20% improvement in RA based on the American College of Rheumatology criteria (ACR20) at 12 weeks. Secondary measures were ACR50, Disease Activity Score (DAS)/European League Against Rheumatism (EULAR) responses and the 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% to 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.
Insights
Pamapimod did not significantly improve rheumatoid arthritis (RA) outcomes compared to placebo in patients already on methotrexate (MTX). Adverse events were generally mild, with infections leading to most discontinuations.
Area of Science:
- Rheumatology
- Clinical Pharmacology
- Immunology
Background:
- Rheumatoid arthritis (RA) is a chronic autoimmune disease impacting joints.
- Methotrexate (MTX) is a common first-line therapy for RA.
- Identifying novel therapeutic agents is crucial for patients with inadequate response to MTX.
Purpose of the Study:
- To evaluate the efficacy and safety of pamapimod in adult RA patients with an insufficient response to MTX.
- To assess pamapimod's impact on American College of Rheumatology (ACR) criteria and Disease Activity Score (DAS).
Main Methods:
- A 12-week, double-blind, randomized controlled trial was conducted.
- Adult RA patients on stable MTX were assigned to pamapimod or placebo groups.
- Efficacy was measured by ACR20 response, with secondary endpoints including ACR50 and DAS/EULAR scores.
Main Results:
- Pamapimod did not demonstrate a statistically significant improvement in ACR20 response rates compared to placebo (31-43% vs. 34%).
- Secondary efficacy measures, including ACR50 and DAS/EULAR responses, showed similar non-significant trends.
- Adverse events were mostly mild, with infections being the primary cause for study drug discontinuation.
Conclusions:
- Pamapimod did not show significant efficacy benefits over placebo in RA patients receiving background MTX therapy.
- The safety profile of pamapimod was generally acceptable, though infections required discontinuation in some cases.
- Further research may be needed to explore pamapimod's role in RA management.
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