WASHINGTON — According to findings presented at the American College of Rheumatology Annual Meeting, 75% of patients with peripheral spondyloarthritis treated with golimumab experienced clinical remission.
Philippe Carron, MD, of the Department of Rheumatology at Ghent University Hospital in Belgium, and colleagues aimed to assess drug-free sustained clinical remission and relapse after induction therapy in a cohort of 60 patients with active peripheral spondyloarthritis (SpA) who were treated with golimumab (Simponi, Janssen) or placebo.
“Efficient treatment options for peripheral SpA are emerging,” Carron said. “But there are questions about how we should use these drugs. Little is known about the natural evolution of peripheral SpA, especially in early forms.”
Forty patients received golimumab 50 mg every 4 weeks for 24 weeks, while 20 patients received placebo on the same schedule. The proportion of patients in clinical remission at 24 weeks served as the primary endpoint. The researchers defined remission as the absence of arthritis, enthesitis and dactylitis on clinical examination.
Primary endpoint results indicated 75% of patients in the study drug group and 20% of patients in the placebo group achieve clinical remission. At week 12, the remission rates were 70% for golimumab and 15% for placebo.
Sustained clinical remission — which was defined as remission at both week 12 and week 24 — was reported in 67.5% of patients in the golimumab arm and in 15% of those in the placebo arm. Treatment was discontinued at 12 weeks in patients who achieved remission. Secondary endpoint results indicated peripheral SpA response criteria rates were 50% in the golimumab group and 15% for placebo at week 24.
All patients underwent at least one follow-up visit 6 months after cessation of therapy, with a maximum follow-up of 52 months. Drug-free, sustained clinical remission was reported in 60% of patients, while 40% had a clinical relapse at this long-term follow-up assessment.
There were 12 patients who relapsed after treatment discontinuation. Ten of those patients (83.3%) had experienced a flare within 6 months of ceasing therapy. Rescue medication were required in 10% of the study drug patients and in 50% of placebo patients between week 12 until week 20. In terms of safety, Carron reported that no new or unexpected events occurred with golimumab.
“The concept of SpA has changed to a more clinical concept,” Carron said. He raised questions about high rates of spontaneous remission, and whether there is a window of opportunity for early intensive intervention.
“The focus of our study is on peripheral articular involvement,” Carron concluded. “Anti-[tumor necrosis factor] TNF treatment early result[s] in high clinical remission rates. Responses were superior to those observed in comparable patients with more longstanding disease.” – by Rob Volansky
Carron P, et al. Abstract #2005. Presented at: The American College of Rheumatology Annual Meeting; Nov. 11-16, 2016; Washington.
Disclosure: Carron reports no relevant financial disclosures.