Arthur Kavanaugh1, Philip Mease. 1. Division of Rheumatology, Allergy, Immunology, University of California San Diego, La Jolla, California 92093-0943, USA. akavanaugh@ucsd.edu
Abstract
OBJECTIVE: To assess longer-term outcomes, including enthesitis and dactylitis, in patients with active psoriatic arthritis (PsA), in a study of golimumab treatment. METHODS:Adult patients with active PsA were randomized to receive subcutaneous injections of placebo (n = 113), golimumab 50 mg (n = 146), or golimumab 100 mg (n = 146) every 4 weeks through Week 20. All patients received golimumab 50 mg or 100 mg from Week 24 onward. Entheses tenderness was scored in 15 body sites using the PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score (MASES). Dactylitis was assessed in 20 digits of the hands and feet. RESULTS: Among the 405 randomized patients, 77% presented with enthesitis and 34% dactylitis at baseline. At Week 24 of the placebo-controlled study phase, significant differences were observed between golimumab 50 mg and/or 100 mg and placebo for mean percent improvement in the PsA-modified MASES [46% (p < 0.001) and 52% (p < 0.001) vs 13%, respectively] and the dactylitis score [66% (p = 0.09) and 82% (p < 0.001) vs 28%, respectively]. By Week 52, improvements were maintained among patients randomized to receive golimumab (mean improvements of 54% for PsA-modified MASES and 77% for the dactylitis score). Those given placebo who had enthesitis or dactylitis at baseline and who crossed over to golimumab at Week 16 or 24 had somewhat less improvement at Week 52 (i.e., 39% for the PsA-modified MASES, 57% for dactylitis score). CONCLUSION: Treatment of PsA patients with the TNF inhibitor golimumab was effective across all components of disease, including enthesitis and dactylitis, and efficacy was maintained over longer-term followup.
RCT Entities:
OBJECTIVE: To assess longer-term outcomes, including enthesitis and dactylitis, in patients with active psoriatic arthritis (PsA), in a study of golimumab treatment. METHODS: Adult patients with active PsA were randomized to receive subcutaneous injections of placebo (n = 113), golimumab 50 mg (n = 146), or golimumab 100 mg (n = 146) every 4 weeks through Week 20. All patients received golimumab 50 mg or 100 mg from Week 24 onward. Entheses tenderness was scored in 15 body sites using the PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score (MASES). Dactylitis was assessed in 20 digits of the hands and feet. RESULTS: Among the 405 randomized patients, 77% presented with enthesitis and 34% dactylitis at baseline. At Week 24 of the placebo-controlled study phase, significant differences were observed between golimumab 50 mg and/or 100 mg and placebo for mean percent improvement in the PsA-modified MASES [46% (p < 0.001) and 52% (p < 0.001) vs 13%, respectively] and the dactylitis score [66% (p = 0.09) and 82% (p < 0.001) vs 28%, respectively]. By Week 52, improvements were maintained among patients randomized to receive golimumab (mean improvements of 54% for PsA-modified MASES and 77% for the dactylitis score). Those given placebo who had enthesitis or dactylitis at baseline and who crossed over to golimumab at Week 16 or 24 had somewhat less improvement at Week 52 (i.e., 39% for the PsA-modified MASES, 57% for dactylitis score). CONCLUSION: Treatment of PsA patients with the TNF inhibitor golimumab was effective across all components of disease, including enthesitis and dactylitis, and efficacy was maintained over longer-term followup.
Authors: Dafna D Gladman; Arthur Kavanaugh; Juan J Gómez-Reino; Jürgen Wollenhaupt; Maurizio Cutolo; Georg Schett; Eric Lespessailles; Benoit Guerette; Nikolay Delev; Lichen Teng; Christopher J Edwards; Charles A Birbara; Philip J Mease Journal: RMD Open Date: 2018-06-27