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

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.

Golimumab, a new human tumor necrosis factor α antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty‐four–week efficacy and safety results of a randomized, placebo‐controlled study

“…Safety evaluations included adverse events, routine laboratory analyses, and the presence of antibodies to golimumab (6). The incidence of malignancies was determined based on 100 patient-years of followup, with corresponding 95% confidence intervals (95% CIs).…”

“…Golimumab is a new human monoclonal antibody against TNF␣ that binds with high affinity and specificity to soluble and transmembrane TNF␣ and has a median terminal half-life of ϳ2 weeks (5). In a phase II rheumatoid arthritis trial, subcutaneous golimumab provided benefit within 2 weeks of administration of the first dose (6).…”

TNFα blockade in human diseases: Mechanisms and future directions

“…In a phase 2, randomized, double-blind dose-ranging trial of a combination therapy of s.c. golimumab and oral MTX versus MTX alone in patients with active RA, golimumab was effective in all dosing groups [101]. After 16 weeks of treatment, more patients in the combined group achieved ACR 20 (62% vs. 37%, P=0.008), ACR 50 (31% vs. 6%) and ACR 70 responses (12% vs. 0), and DAS28 remission including serum CRP levels (27% vs. 6%, P=0.007).…”

Golimumab in psoriatic arthritis: One‐year clinical efficacy, radiographic, and safety results from a phase III, randomized, placebo‐controlled trial

“…Subcutaneous golimumab injections every 4 weeks reduce the signs and symptoms of disease in patients with active rheumatoid arthritis, psoriatic arthritis (PsA), and ankylosing spondylitis (1)(2)(3)(4)(5)(6). We previously reported findings for the clinical efficacy and safety of golimumab through week 24 of the GO-REVEAL study, a phase III, multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA (6).…”