Dataset Information

Efficacy and Safety of Subcutaneous Golimumab in Methotrexate-Naive Patients With Rheumatoid Arthritis: Five-Year Results of a Randomized Clinical Trial.

ABSTRACT:

Objective

To evaluate the safety and efficacy of golimumab through 5 years in adults with active rheumatoid arthritis (RA) who had not previously received methotrexate (MTX).

Methods

In the GO-BEFORE study, 637 MTX-naive adult patients with active RA were randomized (1:1:1:1) to placebo?+?MTX (group 1), golimumab 100 mg?+?placebo (group 2), golimumab 50 mg?+?MTX (group 3), or golimumab 100 mg?+?MTX (group 4). Inadequate responders in groups 1, 2, and 3 entered early escape at week 28 to golimumab 50 mg?+?MTX, golimumab 100 mg?+?MTX, or golimumab 100 mg?+?MTX, respectively; remaining patients in group 1 could cross over to golimumab 50 mg?+?MTX at week 52. Assessments included the American College of Rheumatology 20%/50%/70% improvement criteria (ACR20/50/70) response, the Disease Activity Score in 28 joints (DAS28) using C-reactive protein (CRP) level, and the modified Sharp/van der Heijde score (SHS). Efficacy was analyzed using an intent-to-treat (ITT) analysis. Pharmacokinetics and immunogenicity were evaluated at selected visits.

Results

A total of 422 patients completed golimumab treatment through week 256. At week 256, 72.8%, 54.6%, and 38.0% of all patients in the full ITT population (n?=?637) had an ACR20/50/70 response, respectively; 84.1% had a good or moderate DAS28-CRP response; and 72.7% had a clinically meaningful improvement in physical function. Radiographic progression was minimal in all treatment groups through week 256, and the overall mean change from baseline in SHS was 1.36. Serum trough golimumab concentrations were approximately dose proportional and maintained through week 256. Antibodies to golimumab occurred in 9.6% of patients through week 256. Infections were the most common type of adverse event (AE); 204 of 616 patients (33.1%) had ?1 serious AE.

Conclusion

Clinical efficacy with golimumab treatment was maintained through week 256 of the GO-BEFORE trial of MTX-naive RA patients. No unexpected AEs occurred; safety results through 5 years are consistent with earlier reports.

SUBMITTER: Emery P

PROVIDER: S-EPMC5089605 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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Publications

Efficacy and Safety of Subcutaneous Golimumab in Methotrexate-Naive Patients With Rheumatoid Arthritis: Five-Year Results of a Randomized Clinical Trial.

Emery Paul P Fleischmann Roy M RM Strusberg Ingrid I Durez Patrick P Nash Peter P Amante Eric Jason B EJ Churchill Melvin M Park Won W Pons-Estel Bernardo B Han Chenglong C Gathany Timothy A TA Xu Stephen S Zhou Yiying Y Leu Jocelyn H JH Hsia Elizabeth C EC

Arthritis care & research 20160601 6

<h4>Objective</h4>To evaluate the safety and efficacy of golimumab through 5 years in adults with active rheumatoid arthritis (RA) who had not previously received methotrexate (MTX).<h4>Methods</h4>In the GO-BEFORE study, 637 MTX-naive adult patients with active RA were randomized (1:1:1:1) to placebo + MTX (group 1), golimumab 100 mg + placebo (group 2), golimumab 50 mg + MTX (group 3), or golimumab 100 mg + MTX (group 4). Inadequate responders in groups 1, 2, and 3 entered early escape at week ...[more]

PMID: 26474452

Similar Datasets

Project description:OBJECTIVE:To evaluate the safety and efficacy of intravenous golimumab + methotrexate (MTX) in patients with active rheumatoid arthritis (RA) aged <?65?years and those ??65?years who were enrolled in the GO-FURTHER study. METHODS:In the phase III, double-blind, randomized, placebo-controlled GO-FURTHER trial, patients with active RA were randomized to intravenous (IV) golimumab 2?mg/kg + MTX or placebo + MTX at weeks 0 and 4, then every 8?weeks thereafter (with crossover to golimumab at week 16 [early escape] or week 24 [per-protocol]). The final golimumab infusion was at week 100. Assessments included American College of Rheumatology (ACR) 20/50/70 response criteria. Efficacy and adverse events (AEs) were monitored through 2 years. Efficacy and AEs were summarized for patients aged <?65?years or ??65?years; AEs were also summarized for patients < or ??70?years and patients < or ??75?years. RESULTS:In GO-FURTHER, 592 patients were randomized to receive placebo (n?=?197) or golimumab (n?=?395), 515 were aged <?65?years and 77 were ??65?years. At week 24, ACR20 response rates were greater for golimumab + MTX patients compared with placebo + MTX for patients <?65?years (61.6% vs 31.3%, p?<?0.001) and those ??65?years (69.5% vs 33.3%; p?<?0.01). Infections were the most common AE through week 112 (51.6% in patients <?65?years; 55.3% in patients ??65?years); upper respiratory infections were the most common infection in patients <?65?years (13.2%) and those ??65?years (11.8%). Serious AEs occurred in 17.7% in patients <?65?years and 25.0% of patients ??65?years and included malignancies, pneumonia, fractures, acute pancreatitis, cellulitis, and bacterial arthritis. CONCLUSIONS:In GO-FURTHER, ACR response rates were similar between patients <?65?years and patients ??65?years within each treatment group. AEs in elderly patients were similar to the known safety profile of IV golimumab. Immunosenescence is known to increase the risk of infections in the elderly. Elderly patients had a numerically higher incidence of serious infections. Six malignancies occurred in golimumab-treated patients, all in patients <?65?years. TRIAL REGISTRATION:clinicaltrials.gov: NCT00973479 . Registered September 9, 2009.

Dataset Information

Efficacy and Safety of Subcutaneous Golimumab in Methotrexate-Naive Patients With Rheumatoid Arthritis: Five-Year Results of a Randomized Clinical Trial.

Objective

Methods

Results

Conclusion

Publications

Efficacy and Safety of Subcutaneous Golimumab in Methotrexate-Naive Patients With Rheumatoid Arthritis: Five-Year Results of a Randomized Clinical Trial.

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