Golimumab, a human anti-TNF monoclonal antibody administered subcutaneously every four weeks as monotherapy in patients with active rheumatoid arthritis despite DMARD therapy: 24-week results of clinical and radiographic assessments.

Objective: To assess the efficacy and safety of golimumab (GLM) as a monotherapy in Japanese patients with active rheumatoid arthritis (RA) despite DMARD therapy. Methods: In this multicenter, randomized, double-blind, placebo (PBO)-controlled study, patients with active RA with >=6 swollen and >=6 tender joints (SJC/TJC) despite treatment with DMARD were randomized to subcutaneous injections of PBO, GLM 50mg, or GLM 100mg administered q4 wks. Starting at wk 16, GLM 50mg was administered q4 wks to patients in the PBO group. The primary endpoint was the proportion of patients achieving ACR20 at wk 14. Secondary endpoints included the proportion of patients achieving ACR50, ACR70 response, DAS28 (ESR) response, and improvement in Health Assessment Questionnaire (HAQ) at wk 14, and change from baseline in van der Heijde/Sharp-Score (vdH-S) at wk 24. Data was analyzed using Full Analysis Set (modified Intent-To-Treat: all patients receiving one dose of study treatment included) population. The results of the non-parametric data analyzed using van der Waerden method is being reported. Results: 308 patients received treatment (105 PBO, 101 GLM 50mg, and 102 GLM 100mg). Treatment groups were balanced for baseline demographic and disease characteristics [mean (SD) values for all patients: CRP 2.46(2.62) mg/dL, ESR 47.9(30.18) mm/hr, SJC 12.9(6.49), TJC 15.7(9.25), DAS 28(ESR) 5.89 (1.04)]. The baseline vdH-S(TSS) for the GLM 50mg and 100mg groups were 44.05(50.80) and 56.66 (56.74), respectively. At wk 14, the GLM 50mg and 100mg groups were significantly better than PBO in improving signs and symptoms of RA and physical function (Table). At wk 24, the GLM 100mg group significantly inhibited radiographic progression compared with PBO; the median and IQ ranges clearly showed better inhibition with the GLM 100 mg dose. Through wk 16, the overall incidence of adverse events (AEs) was 63.8%, 62.4%, and 59.8% in the PBO, GLM 50mg, and GLM 100mg groups, respectively; serious AEs occurred in 1.9%, 1.0%, and 2.0% of the patients in the PBO, GLM 50mg, and GLM 100mg groups, respectively. Serious infections occurred in 1.0%, 0%, and 1.0% of patients, respectively, in the PBO, GLM 50mg, and GLM 100mg. Injection site reactions occurred in 6.7%, 7.9%, and 7.8% of patients, respectively. There were no reports of tuberculosis or death. Conclusion: Both doses of GLM significantly improved signs, symptoms, and physical function compared with PBO. In addition GLM 100 mg significantly inhibited progression of structural damage compared with PBO. Injection site reactions were mild and not increased compared with PBO. GLM monotherapy was welltolerated with safety profile similar to other anti-TNF agents. (Table presented).