Abstract
Objective. To evaluate the effects of golimumab therapy on achieving inactive disease or major improvement, as assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS), and improvements in health-related quality of life (HRQOL) and productivity through 2 years in patients with AS.
Methods. In the phase III GO-RAISE trial, 356 patients were randomized to placebo with crossover to golimumab 50 mg at Week 24 (n = 78), golimumab 50 mg (n = 138), or golimumab 100 mg (n = 140) at baseline and every 4 weeks. The proportions of patients with ASDAS major improvement (improvement ≥ 2.0) or inactive disease (score < 1.3) were determined. HRQOL was assessed using the 36-item Medical Outcomes Study Short Form-36 physical/mental component summary (SF-36 PCS/MCS) scores (normal score ≥ 50). The effect of disease on productivity was assessed by visual analog scale (0–10). Regression analyses on the association of disease activity and HRQOL were performed. The final assessment was at Week 104.
Results. Significantly greater proportions of golimumab-treated patients achieved ASDAS major improvement or inactive disease at weeks 14 and 24 versus placebo. Through Week 104, patients who achieved ASDAS inactive disease or major improvement had significantly greater improvements in SF-36 PCS and MCS scores and productivity than did patients not meeting these targets. Among all patients, achieving ASDAS inactive disease at weeks 52 and 104 was associated with normalized SF-36 PCS/MCS scores and significant improvements in work productivity.
Conclusion. Greater proportions of golimumab-treated patients achieved ASDAS major improvement or inactive disease and improved HRQOL versus placebo. Achieving an inactive disease state by ASDAS criteria (< 1.3) was associated with normalized HRQOL through 2 years.
Footnotes
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Supported by Janssen Research & Development LLC and Merck/Schering-Plough. Authors MM, BH, TAG, and CH are employees of the study sponsor and own stock in Johnson & Johnson, of which Janssen Research & Development LLC and Janssen Global Services LLC are subsidiaries. DvdH has received consulting fees and/or research grants from AbbVie, Amgen, AstraZeneca, Augurex, BMS, Celgene, Chugai, Covagen, Daiichi, Eli-Lilly, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, and Vertex and is director of imaging at Rheumatology bv. AD has received payments for educational lectures, teleconferences and serving on advisory boards for Janssen, a company that may have a commercial interest in the results of this research. JB has received honoraria for talks, advisory boards, and grants for studies from Janssen Research & Development LLC, Amgen, Abbott, BMS, Celltrion, Novartis, Pfizer (Wyeth), MSD (Schering-Plough), Roche, Sanofi-Aventis, and UCB. RDI has received consulting fees from Merck, Schering-Plough, Abbott, Amgen, and Sanofi-Aventis.
- Accepted for publication February 12, 2014.