Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis: results of the GO-FORTH study

Abstract

ObjectiveTo assess the efficacy and safety of golimumab + methotrexate (MTX) in Japanese patients with active rheumatoid arthritis (RA).Methods269 Japanese patients with active RA despite treatment with MTX were randomised (1:1:1) to placebo + MTX (Group 1), golimumab 50 mg + MTX (Group 2) or golimumab 100 mg + MTX (Group 3). Subcutaneous golimumab/placebo was injected every 4 weeks; stable doses of oral MTX (6–8 mg/week) were continued. Patients were allowed to enter early escape (Group 1 added golimumab 50 mg, Group 2 increased golimumab to 100 mg, Group 3 continued golimumab 100 mg) based on swollen/tender joint counts at week 14. The primary study endpoint was achievement of at least 20% improvement in the American College of Rheumatology (ACR20) response criteria at week 14. To control for multiplicity of testing, treatment group comparisons were first made between combined Groups 2 and 3 versus Group 1, followed by comparisons of Group 2 and Group 3 versus Group 1.ResultsThe proportion of patients with an ACR20 response at week 14 was significantly higher in combined Groups 2 and 3 (73.4%, 127/173) and in each of Group 2 (72.1%, 62/86) and Group 3 (74.7%, 65/87) compared with Group 1 (27.3%, 24/88; p<0.0001 for all comparisons). Golimumab + MTX also elicited a significantly better response than placebo + MTX in other efficacy parameters, including disease activity score (DAS28) response/remission and radiographic assessments. During the 16-week fixed treatment regimen study period, 72.7%, 75.6% and 78.2% of patients had adverse events and 1.1%, 1.2% and 2.3% had serious adverse events in Groups 1, 2 and 3, respectively.ConclusionIn Japanese patients with active RA despite MTX therapy, golimumab + MTX was significantly more effective than MTX monotherapy in reducing RA signs/symptoms and limiting radiographic progression with no unexpected safety concerns.

Safety, Effectiveness, and Treatment Persistence of Golimumab in Elderly Patients with Rheumatoid Arthritis in Real-World Clinical Practice in Japan

“…While the safety and effectiveness of GLM in the younger group reported here corroborate previous clinical trial data [18,19,31,32], the current study demonstrated, for the first time, that the safety and effectiveness of GLM in elderly (75 B years) Japanese patients with active RA are comparable to those in younger (75[years) patients. It should be noted that, in elderly patients, the frequency of concomitant MTX use, which has been proven to be effective for anti-TNF agents, is lower than that in younger patients albeit with higher baseline disease activity.…”

“…Recent clinical studies in Japan, GO-FORTH [18] and GO-MONO [19], have demonstrated efficacy and safety of GLM in patients with active RA. However, elderly patients aged 75 years or over were excluded in both GLM clinical trials despite the fact that patients aged 70 years or over account for 35.4% of the total number of patients enrolled in the post-marketing surveillance (PMS) of GLM [20].…”

A Paradigm Shift in Rheumatoid Arthritis over the Past Decade

“…Moreover, in a Japanese trial of tocilizumab (61), increases in the total Sharp score (TSS) and its components and the erosion and joint narrowing scores were significantly lower with tocilizumab monotherapy than in DMARD therapy, providing the first evidence that biologics are superior to DMARDs for inhibiting structural damage. Subsequent clinical trials and studies of other biologic agents with methotrexate revealed a striking inhibition of structural damage, indicating that joint damage in RA can be attenuated (61)(62)(63)(64)(65)(66)(67) (Fig. 3).…”

Monitoring Anti-Tnf Drug Treatment in Inflammatory Bowel Disease. Is it Useful in Clinical Practice?

“…West et al [39] partially confirmed these results, although the patients with high aTNF-a levels in their study had lower response rates to ADA. CTZ and golimumab have been studied less but appear to maintain this relationship [72][73][74][75]. UC presents lower response rates than CD in anti-TNF therapy.…”