Golimumab, a human antibody to tumour necrosis factor   given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study

Abstract

Objective:The phase III GO-FORWARD study examined the efficacy and safety of golimumab in patients with active rheumatoid arthritis (RA) despite methotrexate therapy.Methods:Patients were randomly assigned in a 3 : 3 : 2 : 2 ratio to receive placebo injections plus methotrexate capsules (group 1, n = 133), golimumab 100 mg injections plus placebo capsules (group 2, n = 133), golimumab 50 mg injections plus methotrexate capsules (group 3, n = 89), or golimumab 100 mg injections plus methotrexate capsules (group 4, n = 89). Injections were administered subcutaneously every 4 weeks. The co-primary endpoints were the proportion of patients with 20% or greater improvement in the American College of Rheumatology criteria (ACR20) at week 14 and the change from baseline in the health assessment questionnaire-disability index (HAQ-DI) score at week 24.Results:The proportion of patients who achieved an ACR20 response at week 14 was 33.1% in the placebo plus methotrexate group, 44.4% (p = 0.059) in the golimumab 100 mg plus placebo group, 55.1% (p = 0.001) in the golimumab 50 mg plus methotrexate group and 56.2% (p<0.001) in the golimumab 100 mg plus methotrexate group. At week 24, median improvements from baseline in HAQ-DI scores were 0.13, 0.13 (p = 0.240), 0.38 (p<0.001) and 0.50 (p<0.001), respectively. During the placebo-controlled portion of the study (to week 16), serious adverse events occurred in 2.3%, 3.8%, 5.6% and 9.0% of patients and serious infections occurred in 0.8%, 0.8%, 2.2% and 5.6%, respectively.Conclusion:The addition of golimumab to methotrexate in patients with active RA despite methotrexate therapy significantly reduced the signs and symptoms of RA and improved physical function.

Phase II study of tofacitinib (CP‐690,550) combined with methotrexate in patients with rheumatoid arthritis and an inadequate response to methotrexate

“…Alternatively, these observations could be due to differences in MTX dosing. In Asian countries such as Korea, where higher MTX doses than those used in Japan can be administered, efficacy results reported, for example, for the DMARD golimumab, were similar to those obtained from global studies (18).…”

Evaluation of therapeutic targets in animal models of arthritis: How does it relate to rheumatoid arthritis?

“…Two new TNF inhibitors, golimumab (a fully human anti-TNF␣ monoclonal antibody) and certolizumab pegol (a PEGylated FabЈ fragment of a humanized anti-TNF monoclonal antibody), have more recently been shown to be effective in the treatment of RA (83)(84)(85)(86)(87)(88). Thus, TNF␣ has clearly been proven to be a good target for RA treatment and has fulfilled the expectations raised during the preclinical studies performed in animal models.…”

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).…”