Objectives To evaluate the efficacy and safety of golimumab in patients with active peripheral Spondyloarthritis (pSpA) in a very early stage of the disease.
Methods CRESPA (Clinical REmission in peripheral SPondyloArthritis) is an ongoing monocentric study of golimumab treatment in pSpA patients. Eligible patients were ≥18 years and fulfilled the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for pSpA. All patients had a symptom duration of less than 3 months. Patients were randomized 2:1 to receive golimumab 50 mg every 4 weeks or matching placebo for 24 weeks. The primary endpoint was the percentage of patients achieving clinical remission at week 24. Clinical remission was defined as the absence of arthritis, enthesitis and dactylitis on clinical examination. From week 12 onwards, there was an option to start rescue medication with golimumab 50 mg SC every 4 weeks. Adverse events were recorded throughout the study.
Results In total 60 patients were randomized of whom 20 to the placebo group and 40 to the golimumab group. Baseline demographics and disease characteristics were generally similar between the 2 groups. At week 24 a significant higher percentage of patients receiving golimumab achieved clinical remission compared to patients receiving placebo (75% (30/40) versus 20% (4/20); P<0.001). At week 12 similar results were observed (70% (28/40) versus 15% (3/20); P<0.001). Overall, improvement in other outcomes was significantly greater in the golimumab group compared to the placebo group (table 1). In the placebo group 10 out of 20 patients (50%) entered the rescue arm, compared to only 4 of 40 (10%) patients in the golimumab arm. The rates of adverse events were very low and similar in both treatment groups.
Conclusions In patients with active, very early peripheral spondyloarthritis, treatment with golimumab led to high percentages of clinical remission and significant improvement in all secondary efficacy outcomes, compared to placebo, with a safety profile consistent with that observed in anti-TNF trials with ankylosing spondylitis and psoriatic arthritis patients.
Disclosure of Interest None declared