Benefit of Golimumab on Radiographic Progression Reported in Psoriatic Arthritis

Philadelphia—Golimumab inhibited progression of radiographic damage to joints in patients with psoriatic arthritis (PSA), according to 52-week results of the randomized, controlled the GO-REVEAL (Golimumab-Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody) study reported at the ACR meeting. Arthur F. Kavanaugh, MD, of the University of California San Diego presented results a late-breaking news session.

Golimumab, an injectable anti-tumor necrosis factor (TNF) agent, was approved by the Food and Drug Administration in April 2009 for the treatment of rheumatoid arthritis, PSA, and ankylosing spondylitis. A previous analysis of this pivotal trial showed that golimumab improved articular and dermatologic manifestations of PSA, functional status, and quality of life in this disease. The present study reported the effect of 2 different doses of the drug on the progression of structural damage, as assessed by radiography.

GO-REVEAL enrolled 405 patients with PSA and a mean age of 46 to 48 years. Median number of swollen joints was 12 to 14, and median number of tender joints was 22 to 24.

Patients were randomized to receive either subcutaneous (sc) placebo, or sc golimumab 50 mg or 100 mg every 4 weeks. If patients had <10% improvement in swollen and tender joints at week 16, they entered an early escape phase in a double-blinded manner to either golimumab 50 mg (the placebo group) or golimumab 100 mg (those previously treated with the 50 mg dose). All placebo patients were treated with golimumab 50 mg from week 24 to week 52. Week 24 comparisons between groups were based on the original assigned treatment, even for those who entered the early escape phase and were switched to a different treatment. Statistical comparisons were performed only at week 24 due to lack of an adequate control arm, explained Dr. Kavanaugh.

Significantly less radiographic damage was seen in the 50 mg treatment group compared with placebo (P=.011) according to change from baseline in total van der Heijde-Sharp (vdH-S) score. No progression of radiographic damage was seen in significantly more patients who received both doses of the drug versus placebo, as reflected by change in total vdH-S score <0 from baseline (P=.007 for the 50 mg group and P=.020 for the 100 mg group).

In a subset of patients free of erosions and joint space narrowing at baseline, significantly more patients treated with golimumab maintained that state versus those randomized to placebo (P=.003 and P<.001 for the 50 mg and 100 mg groups, respectively). At week 52, less disease progression was observed in patients who were randomized to active drug treatment.—Alice Goodman