Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: A randomized, double-blind, placebo-controlled, dose-ranging study

Jonathan Kay, Eric Lawrence Matteson, Bhaskar Dasgupta, Peter Nash, Patrick Durez, Stephen Hall, Elizabeth C. Hsia, John Han, Carrie Wagner, Zhenhua Xu, Sudha Visvanathan, Mahboob U. Rahman

Research output: Contribution to journalArticle

247 Citations (Scopus)

Abstract

Objective. To assess the efficacy, safety, and pharmacology of subcutaneous administration of golimumab in patients with active rheumatoid arthritis (RA) despite treatment with methotrexate (MTX). Methods. Patients were randomly assigned in a double-blinded manner to receive injections of placebo plus MTX or 50 mg or 100 mg golimumab every 2 or 4 weeks plus MTX through week 48. Patients originally assigned to receive injections every 2 weeks had the interval increased to every 4 weeks starting at week 20. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 16. The study was powered to detect a difference in the primary end point when the combined golimumab groups and at least 1 of the individual dose groups were compared with placebo. Results. The primary end point was attained. Sixty-one percent of patients in the combined golimumab plus MTX dose groups achieved an ACR20 response at week 16 compared with 37% of patients in the placebo plus MTX group (P = 0.010). In addition, 79% of patients in the group receiving 100 mg golimumab every 2 weeks achieved an ACR20 response (P < 0.001 versus placebo). Through week 20 (after which patients receiving placebo were switched to active infliximab therapy), serious adverse events were reported in 9% of patients in the combined golimumab groups and in 6% of patients in the placebo group. Conclusion. Golimumab plus MTX effectively reduces the signs and symptoms of RA and is generally well tolerated in patients with an inadequate response to MTX.

Original languageEnglish (US)
Pages (from-to)964-975
Number of pages12
JournalArthritis and Rheumatism
Volume58
Issue number4
DOIs
StatePublished - Apr 2008

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Methotrexate
Rheumatoid Arthritis
Placebos
Therapeutics
golimumab
Injections
Signs and Symptoms
Pharmacology
Safety

ASJC Scopus subject areas

  • Immunology
  • Rheumatology

Cite this

Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate : A randomized, double-blind, placebo-controlled, dose-ranging study. / Kay, Jonathan; Matteson, Eric Lawrence; Dasgupta, Bhaskar; Nash, Peter; Durez, Patrick; Hall, Stephen; Hsia, Elizabeth C.; Han, John; Wagner, Carrie; Xu, Zhenhua; Visvanathan, Sudha; Rahman, Mahboob U.

In: Arthritis and Rheumatism, Vol. 58, No. 4, 04.2008, p. 964-975.

Research output: Contribution to journalArticle

Kay, J, Matteson, EL, Dasgupta, B, Nash, P, Durez, P, Hall, S, Hsia, EC, Han, J, Wagner, C, Xu, Z, Visvanathan, S & Rahman, MU 2008, 'Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: A randomized, double-blind, placebo-controlled, dose-ranging study', Arthritis and Rheumatism, vol. 58, no. 4, pp. 964-975. https://doi.org/10.1002/art.23383
Kay, Jonathan ; Matteson, Eric Lawrence ; Dasgupta, Bhaskar ; Nash, Peter ; Durez, Patrick ; Hall, Stephen ; Hsia, Elizabeth C. ; Han, John ; Wagner, Carrie ; Xu, Zhenhua ; Visvanathan, Sudha ; Rahman, Mahboob U. / Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate : A randomized, double-blind, placebo-controlled, dose-ranging study. In: Arthritis and Rheumatism. 2008 ; Vol. 58, No. 4. pp. 964-975.
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AU - Matteson, Eric Lawrence

AU - Dasgupta, Bhaskar

AU - Nash, Peter

AU - Durez, Patrick

AU - Hall, Stephen

AU - Hsia, Elizabeth C.

AU - Han, John

AU - Wagner, Carrie

AU - Xu, Zhenhua

AU - Visvanathan, Sudha

AU - Rahman, Mahboob U.

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N2 - Objective. To assess the efficacy, safety, and pharmacology of subcutaneous administration of golimumab in patients with active rheumatoid arthritis (RA) despite treatment with methotrexate (MTX). Methods. Patients were randomly assigned in a double-blinded manner to receive injections of placebo plus MTX or 50 mg or 100 mg golimumab every 2 or 4 weeks plus MTX through week 48. Patients originally assigned to receive injections every 2 weeks had the interval increased to every 4 weeks starting at week 20. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 16. The study was powered to detect a difference in the primary end point when the combined golimumab groups and at least 1 of the individual dose groups were compared with placebo. Results. The primary end point was attained. Sixty-one percent of patients in the combined golimumab plus MTX dose groups achieved an ACR20 response at week 16 compared with 37% of patients in the placebo plus MTX group (P = 0.010). In addition, 79% of patients in the group receiving 100 mg golimumab every 2 weeks achieved an ACR20 response (P < 0.001 versus placebo). Through week 20 (after which patients receiving placebo were switched to active infliximab therapy), serious adverse events were reported in 9% of patients in the combined golimumab groups and in 6% of patients in the placebo group. Conclusion. Golimumab plus MTX effectively reduces the signs and symptoms of RA and is generally well tolerated in patients with an inadequate response to MTX.

AB - Objective. To assess the efficacy, safety, and pharmacology of subcutaneous administration of golimumab in patients with active rheumatoid arthritis (RA) despite treatment with methotrexate (MTX). Methods. Patients were randomly assigned in a double-blinded manner to receive injections of placebo plus MTX or 50 mg or 100 mg golimumab every 2 or 4 weeks plus MTX through week 48. Patients originally assigned to receive injections every 2 weeks had the interval increased to every 4 weeks starting at week 20. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 16. The study was powered to detect a difference in the primary end point when the combined golimumab groups and at least 1 of the individual dose groups were compared with placebo. Results. The primary end point was attained. Sixty-one percent of patients in the combined golimumab plus MTX dose groups achieved an ACR20 response at week 16 compared with 37% of patients in the placebo plus MTX group (P = 0.010). In addition, 79% of patients in the group receiving 100 mg golimumab every 2 weeks achieved an ACR20 response (P < 0.001 versus placebo). Through week 20 (after which patients receiving placebo were switched to active infliximab therapy), serious adverse events were reported in 9% of patients in the combined golimumab groups and in 6% of patients in the placebo group. Conclusion. Golimumab plus MTX effectively reduces the signs and symptoms of RA and is generally well tolerated in patients with an inadequate response to MTX.

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