Golimumab (Simponi) is safe and effective in patients with psoriatic arthritis (PsA) through 5 years, according to results of the GO-REVEAL long-term extension study published in the Annals of the Rheumatic Diseases. The trial is the first to measure the drug’s effects over 5 years.
Golimumab, a tumor necrosis factor blocker, has been an approved treatment for PsA since 2009. The trial, a phase 3, randomized, double-blind, placebo-controlled trial in patients with active PsA, showed positive efficacy/safety results in patients with active PsA who were assigned golimumab 50 mg and 100 mg given subcutaneously every 4 weeks.
The results of the extension trial mirror the previously reported golimumab efficacy/safety data. Patients treated with golimumab displayed significant and/or clinically meaningful improvements in all aspects of PsA versus placebo.
“The current report extends the golimumab experience by three years, representing the longest available clinical trial data of chronic anti-TNF treatment of PsA patients,” wrote Arthur F. Kavanaugh, MD, of University of California San Diego, and colleagues.
The researchers assessed golimumab’s long-term efficacy and safety in adults with active PsA, defined as three or more swollen and tender joints plus active psoriasis.
Patients (n=405) in the long-term trial were randomly assigned to receive subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks through week 20. All patients received golimumab 50 mg or 100 mg every 4 weeks from week 24 forward.
Results from the last efficacy evaluation at week 256 revealed that 63% to 70% and 43% to 51% of patients across randomized groups improved by at least 20 % and 50%, respectively, based on the American College of Rheumatology response criteria. The GO-REVEAL trial retained more than two-thirds of randomized patients through 5 years
In addition, meaningful improvements were also noted in patients’ physical function, enthesitis, dactylitis, and skin manifestations, including more than 60% of patients achieving 75% improvement on the Psoriasis Area and Severity Index at week 256.
The researchers highlighted that minimal changes in radiographic scores occurred from baseline to week 256, which suggests a long-term effect of golimumab on inhibiting radiographic progression.
Among the 405 patients, 31% (n=126) discontinued study treatment through week 252 and five patients died from causes unrelated to the study. In general, no differences in the types of adverse events were observed between golimumab doses.
Although the researchers cited the lack of a long-term control arm and golimumab dose changes as study limitations, the data indicates golimumab is safe and effective for long-term use.
“Despite discussed limitations, the safety and efficacy of golimumab, 50 mg and 100 mg administered subcutaneously q4wks to patients with active PsA were demonstrated through 5 years, as evidenced by sustained clinical and radiographic efficacy and a safety profile consistent with other anti-TNF agents used for PsA,” concluded the authors.