Kavanaugh A, et al. – In this present study, the safety and efficacy of intravenous golimumab were examined in psoriatic arthritis (PsA). Outcomes displayed that patients receiving intravenous golimumab 2 mg/kg had significantly greater improvements in the signs/symptoms of PsA and less radiographic progression through week 24. However, adverse events were consistent with those seen with other anti–tumor necrosis factor agents.

Methods

• In this trial, patients were randomized to intravenous placebo (n=239) or golimumab 2 mg/kg (n=241) at weeks 0, 4, 12, and 20.
• The proportion of patients with ≥20% improvement in ACR criteria (ACR20) at week 14 was considered as the primary endpoint.
• Controlled secondary endpoints included change from baseline in Health Assessment Questionnaire–Disability Index (HAQ–DI), proportions of patients with ACR50, ACR70, and ≥75% improvement in Psoriasis Area and Severity Index (PASI75) at week14, and change from baseline in total PsA–modified van der Heijde–Sharp (vdH–S) score at week24.

Results

• At week 14, 75.1% in the golimumab group achieved ACR20 vs. 21.8% in the placebo group (p<0.001).
• At week 14, 75.1% in the golimumab group achieved ACR20 vs. 21.8% in the placebo group (p<0.001).
• Outcomes revealed that patients in the golimumab group had greater mean changes at week14 in HAQ–DI compared with placebo (–0.60 vs –0.12; p<0.001).
• At week 24, the mean change in total modified vdH–S score was –0.4 in the golimumab group and 2.0 in the placebo group (p<0.001).
• Through week 24, 40.6% of patients in the placebo group and 46.3% in the golimumab group had ≥1 adverse event; infections were the most common type.