Golimumab, a human TNF-alpha antibody, administered every 4 weeks as a subcutaneous injection in psoriatic arthritis: Clinical efficacy, radiographic, and safety findings through 1year of the randomized, placebo-controlled, GO-REVEAL study
Arthritis & Rheumatism, 04/23/2012
Kavanaugh A et al. – Treatment with golimumab inhibited structural damage progression and demonstrated continued clinical efficacy and safety through 1year.Methods
- Adult psoriatic arthritis (PsA) patients with active psoriasis (≥3 swollen and ≥3 tender joints) were randomly assigned to receive subcutaneous placebo, golimumab 50mg, or golimumab 100mg every 4weeks through week20.
- At week16, patients with <10% improvement from baseline in swollen and tender joint counts entered blinded early escape (EE), with placebo crossover to golimumab 50mg, golimumab 50mg increasing to 100mg, and golimumab 100mg continuing with 100mg.
- Placebo patients not entering EE crossed over to golimumab 50mg at week24.
- Findings through 1year are reported, including the second of two coprimary endpoints (ie, change from baseline to week24 in PsA–modified Sharp/van der Heijde score [SHS]).
- 405 patients were randomized: 113 to placebo and 146 to each golimumab 50mg and 100mg groups.
- Mean changes in PsA–modified SHS from baseline to week24 for the combined golimumab 50mg and 100mg (–0.09, p=0.015) and golimumab 50mg (–0.16, p=0.011) groups were significantly different versus placebo (0.27).
- Radiographic benefit was maintained through week52 with golimumab.
- Clinical efficacy, including improvement in joint and skin responses and physical function, was maintained through 1year.
- The frequency/types of adverse events were similar to those reported through week24.