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Evaluation of the efficacy and safety of pamapimod, a p38 MAP kinase inhibitor, in a double-blind, methotrexate-controlled study of patients with active rheumatoid arthritis.
Arthritis Rheum. 2009 Feb; 60(2):335-44.AR

Abstract

OBJECTIVE

To determine the efficacy and safety of pamapimod (a selective inhibitor of the alpha-isoform of p38 MAP kinase) as monotherapy in comparison with methotrexate (MTX) treatment in adult patients with active rheumatoid arthritis (RA).

METHODS

Patients were randomly assigned to 1 of 4 treatment groups and received 12 weeks of double-blind treatment. One group received MTX (7.5 mg/week with planned escalation to 20 mg/week), and 3 groups received pamapimod (50, 150, or 300 mg) once daily. The primary efficacy end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at 12 weeks. Secondary end points included ACR50 and ACR70 responses, change from baseline in the Disease Activity Score in 28 joints (DAS28), categorical analyses of DAS28/European League Against Rheumatism response, and change from baseline in each parameter of the ACR core set of measures. Safety monitoring included recording of adverse events (AEs), laboratory testing, immunology assessments, administration of electrocardiograms, and assessment of vital signs.

RESULTS

Patients assigned to receive MTX and pamapimod had similar demographics and baseline characteristics. At week 12, fewer patients taking pamapimod had an ACR20 response (23%, 18%, and 31% in the 50-, 150-, and 300-mg groups, respectively) compared with patients taking MTX (45%). Secondary efficacy end points showed a similar pattern. AEs were typically characterized as mild and included infections, skin disorders, and dizziness. Pamapimod was generally well tolerated, but the 300-mg dose appeared to be more toxic than either the 2 lower doses or MTX.

CONCLUSION

The present results showed that pamapimod was not as effective as MTX in the treatment of active RA.

Authors+Show Affiliations

Metroplex Clinical Research, Dallas, Texas 75235, USA. scohen@arthdocs.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19180516

Citation

Cohen, Stanley B., et al. "Evaluation of the Efficacy and Safety of Pamapimod, a P38 MAP Kinase Inhibitor, in a Double-blind, Methotrexate-controlled Study of Patients With Active Rheumatoid Arthritis." Arthritis and Rheumatism, vol. 60, no. 2, 2009, pp. 335-44.
Cohen SB, Cheng TT, Chindalore V, et al. Evaluation of the efficacy and safety of pamapimod, a p38 MAP kinase inhibitor, in a double-blind, methotrexate-controlled study of patients with active rheumatoid arthritis. Arthritis Rheum. 2009;60(2):335-44.
Cohen, S. B., Cheng, T. T., Chindalore, V., Damjanov, N., Burgos-Vargas, R., Delora, P., Zimany, K., Travers, H., & Caulfield, J. P. (2009). Evaluation of the efficacy and safety of pamapimod, a p38 MAP kinase inhibitor, in a double-blind, methotrexate-controlled study of patients with active rheumatoid arthritis. Arthritis and Rheumatism, 60(2), 335-44. https://doi.org/10.1002/art.24266
Cohen SB, et al. Evaluation of the Efficacy and Safety of Pamapimod, a P38 MAP Kinase Inhibitor, in a Double-blind, Methotrexate-controlled Study of Patients With Active Rheumatoid Arthritis. Arthritis Rheum. 2009;60(2):335-44. PubMed PMID: 19180516.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of the efficacy and safety of pamapimod, a p38 MAP kinase inhibitor, in a double-blind, methotrexate-controlled study of patients with active rheumatoid arthritis. AU - Cohen,Stanley B, AU - Cheng,Tien-Tsai, AU - Chindalore,Vishala, AU - Damjanov,Nemanja, AU - Burgos-Vargas,Ruben, AU - Delora,Patricia, AU - Zimany,Kathleen, AU - Travers,Helen, AU - Caulfield,John P, PY - 2009/1/31/entrez PY - 2009/1/31/pubmed PY - 2009/4/2/medline SP - 335 EP - 44 JF - Arthritis and rheumatism JO - Arthritis Rheum VL - 60 IS - 2 N2 - OBJECTIVE: To determine the efficacy and safety of pamapimod (a selective inhibitor of the alpha-isoform of p38 MAP kinase) as monotherapy in comparison with methotrexate (MTX) treatment in adult patients with active rheumatoid arthritis (RA). METHODS: Patients were randomly assigned to 1 of 4 treatment groups and received 12 weeks of double-blind treatment. One group received MTX (7.5 mg/week with planned escalation to 20 mg/week), and 3 groups received pamapimod (50, 150, or 300 mg) once daily. The primary efficacy end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at 12 weeks. Secondary end points included ACR50 and ACR70 responses, change from baseline in the Disease Activity Score in 28 joints (DAS28), categorical analyses of DAS28/European League Against Rheumatism response, and change from baseline in each parameter of the ACR core set of measures. Safety monitoring included recording of adverse events (AEs), laboratory testing, immunology assessments, administration of electrocardiograms, and assessment of vital signs. RESULTS: Patients assigned to receive MTX and pamapimod had similar demographics and baseline characteristics. At week 12, fewer patients taking pamapimod had an ACR20 response (23%, 18%, and 31% in the 50-, 150-, and 300-mg groups, respectively) compared with patients taking MTX (45%). Secondary efficacy end points showed a similar pattern. AEs were typically characterized as mild and included infections, skin disorders, and dizziness. Pamapimod was generally well tolerated, but the 300-mg dose appeared to be more toxic than either the 2 lower doses or MTX. CONCLUSION: The present results showed that pamapimod was not as effective as MTX in the treatment of active RA. SN - 0004-3591 UR - https://www.unboundmedicine.com/medline/citation/19180516/Evaluation_of_the_efficacy_and_safety_of_pamapimod_a_p38_MAP_kinase_inhibitor_in_a_double_blind_methotrexate_controlled_study_of_patients_with_active_rheumatoid_arthritis_ L2 - https://doi.org/10.1002/art.24266 DB - PRIME DP - Unbound Medicine ER -