Long-Term Golimumab is Safe, Effective for Methotrexate-naïve Patients with RA
SAN DIEGO, CA—Golimumab plus methotrexate maintains improvements in signs and symptoms of rheumatoid arthritis and physical function and inhibits structural damage progression long-term, according to a study presented at the 2013 ACR/ARHP Annual Meeting.
Paul Emery, MA, MD, of Leeds Institute of Molecular Medicine, Leeks, UK, and colleagues evaluated final 5-year safety and efficacy results of the phase 3 GO-BEFORE trial in methotrexate-naïve patients with RA.
Patients in GO-BEFORE were randomized to placebo plus methotrexate, golimumab 100mg + placebo, golimumab 50mg + methotrexate, or golimumab 100mg + methotrexate every 4 weeks. At Weeks 28 (blinded early escape) or 52 (patients with ≥1 swollen/tender joint) patients in the placebo + methotrexate group crossed over to golimumab + methotrexate.
After the last patient completed Week 52 and unblinding occurred, patients receiving placebo + methotrexate could switch to golimumab 50mg + methotrexate. Additionally, corticosteroid use could be adjusted and a one-time golimumab dose change was permitted at the investigator's discretion, either 50mg to 100mg or 100mg to 50mg. Final golimumab injection was at Week 252.
Of 627 patients, 3 were never treated; 419 continued treatment through Week 252, and 215 patients withdrew (111 for adverse events, 23 for lack of efficacy, 20 lost to follow-up, 53 for other reasons, and 8 deaths). Of those who finished treatment, 402 completed the safety follow-up through study end.
At Week 256, 84.3% of all patients had an ACR20, 93.9% had DAS28-CRP EULAR response, and 80.6% had improvement in HAQ-DI ≥0.25. Mean changes in total vdH-S score from baseline were small, and 64% of golimumab + methotrexate patients had no radiographic progression (delta vdH-S≤0).
Common adverse events included upper respiratory tract infection (29.4%), nausea (19.6%), bronchitis (16.6%), and increased alanine aminotransferase (16.1%); in addition, 11.9% had an injection-site reaction. Through Week 268, 204 of 616 (33.1%) of patients had a serious adverse event (AE), with 17.5% of patients discontinuing study agent due to AEs. Overall rates of serious infections, malignancies, and death were 12.2%, 3.4%, and 1.9%, respectively. Of 595 patients with available samples, 58 (9.7%) were positive for antibodies to golimumab.The retention rate was high (66.1%) through 5 years. No new safety signals were detected through study end. The investigators noted that as with all long-term analyses, there are limitations, which included lack of a control group beyond Week 52 and adjustments to concomitant medications.