Results from a randomized controlled trial published in Arthritis Care & Research support the efficacy and safety of intravenous golimumab as treatment for psoriatic arthritis (PsA).
Investigators conducted a randomized placebo-controlled trial of 480 adults with PsA. Patients were randomly assigned to receive intravenous golimumab 2 mg/kg (n=241) at weeks 0, 4, and every 8 weeks thereafter or placebo (n=239) at weeks 0, 4, 12, and 20. At week 24, all patients in the placebo group crossed over to receive golimumab 2 mg/kg at weeks 24, 28, and every 8 weeks thereafter; the final study infusions were administered at week 52. Efficacy through week 52 was described as ≥20%, 50%, or 70% improvement in American College of Rheumatology criteria (ACR20/50/70) and ≥75% improvement in Psoriasis Area and Severity Index (PASI75). Radiographic progression was measured using the PsA-modified van der Heijde-Sharp (vdH-S) score. Adverse events were monitored through week 60.
At week 52, 76.8% of patients in the golimumab group and 77.0% in the placebo-crossover group achieved ACR20 response; 58.1% and 53.6%, respectively, achieved an ACR50 response; and 38.6% and 33.9%, respectively, achieved an ACR70 response. In patients with ≥3% body surface area affected, 71.9% in the golimumab group and 60.6% in the placebo-crossover group achieved a PASI75 response at week 52. Mean change from baseline in total vdH-S score was −0.5 in the golimumab group and 0.8 in the placebo-crossover group. At week 52, 42.3% and 33.9% of patients in the golimumab group and the placebo-crossover group, respectively, achieved minimal disease activity.
Through week 60, 50.9% of all golimumab-treatment patients had ≥1 adverse event and 5.2% ≥1 severe adverse event. No opportunistic infections were observed during the trial period, although 2 malignancies and 1 death occurred in golimumab-treated patients.
These data support the efficacy of golimumab, with patients achieving sustained improvements in joint and skin disease over 1 year of treatment. Adverse events during the trial were consistent with existing safety data.
Husni ME, Kavanaugh A, Murphy F, et al. Efficacy and safety of intravenous golimumab through 1 year in patients with active psoriatic arthritis [published online April 12, 2019]. Arthritis Care Res. doi:10.1002/acr.23905