Golimumab along with methotrexate (MTX) is recommended as a possible treatment for some adults with severe active rheumatoid arthritis (RA). Golimumab is a preferred option for those who have already tried other disease-modifying anti-rheumatic drugs (DMARDs) like tumour necrosis factor inhibitor (TNFi).

Rheumatoid arthritis is a chronic inflammatory disease characterized by progressive joint destruction causing pain, loss of function, decreased quality of life and increasing mortality.  Huffstutter J E, et al. conducted a study to evaluate the efficacy and safety of subcutaneous (SC) golimumab + MTX in patients with active RA despite etanercept + MTX or adalimumab + MTX therapy and evaluated whether intravenous (IV) golimumab could rescue the patients nonrespondent to SC golimumab.

The study included 433 patients with active RA with inadequate responses to etanercept or adalimumab + MTX. Patients were randomly assigned to receive either golimumab 50 mg subcutaneous (SC) over the course of every 4 weeks through week 12, combined with MTX.  Disease Activity Score 28- erythrocyte sedimentation rate  (DAS28-ESR) good responders at week 16 continued open-label SC golimumab through week 52 (Group 1); nonresponders were randomized to double-blind golimumab SC 50 mg (Group 2-SC) or IV 2 mg/kg (Group 2-IV).

Week 14 ACR20 was the primary endpoint, and the assessments continued through week 52 and for patients in the voluntary long-term extension through week 76. Secondary endpoints included ACR20 at week 52 relative to week 16 in Group 2-SC and Group 2-IV.

An improvement in the ACR score (ACR20) at week 14 was reported in 34.9%. In Groups 2-SC (n = 91) and 2-IV (n = 184), 13.2% and 9.2% had an ACR20 at week 52 relative to week 16, with no significant difference between the randomized groups; 42.9% and 47.8% achieved DAS28-ESR response relative to week 0. However, the study showed that there was no difference in rates of adverse events between SC and IV golimumab from week 16 to 52. Study limitations included a higher than expected discontinuation rate as a result of a programming error.

Thr trial results showed that golimumab (SC) in combination with MTX in patients with active RA showed greater clinical response and significantly suppressed disease activity in RA patients with inadequate response to etanercept and adalimumab + MTX. In this multicenter trial, golimumab + MTX elicited a significant better response in various efficacy parameters, including disease activity score (DAS28) response. However, patients in Groups 2-SC and 2-IV had reported lower response rates than Group 1, with no difference between SC or IV mode of administration.