Objective To evaluate the efficacy and safety of golimumab to induce clinical remission in patients with very early, active peripheral spondyloarthritis (pSpA).
Methods Clinical REmission in peripheral SPondyloArthritis is a monocentric study of golimumab treatment in patients with pSpA. All patients fulfilled the Assessment of SpondyloArthritis international Society classification criteria for pSpA, with a symptom duration ≤12 weeks. Patients were randomised 2:1 to receive golimumab 50 mg every 4 weeks or matching placebo for 24 weeks. The primary end point was the percentage of patients achieving clinical remission at week 24, defined as absence of arthritis, enthesitis and dactylitis. Secondary end points included joint and enthesis counts, patient-reported outcomes, erythrocyte sedimentation rate and C reactive protein. From week 12, non-responders were allowed to receive rescue medication with golimumab. Adverse events were recorded.
Results 60 patients were randomised with similar baseline characteristics. At week 24, a significantly higher percentage of patients receiving golimumab achieved clinical remission compared with placebo (75% (30/40) vs 20% (4/20); p<0.001). At week 12, similar results were observed (70% (28/40) vs 15% (3/20); p<0.001). All secondary end points were met at week 24. Rescue medication was necessary in 50% in the placebo group opposed to only 10% in the golimumab arm. Rates of adverse events were low and similar in both groups.
Conclusions Markedly high remission induction rates were noted with golimumab in very early pSpA. Of interest, in placebo-treated patients, very low spontaneous remission rates were observed.
Trial registration number NCT01426815; Results.
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Handling editor Tore K Kvien
DE and FVdB contributed equally.
Contributors PC, DE and FVdB: study concept and design. PC, GV, HC, LVP, DE and FVdB: data acquisition. PC, GV, DE and FVdB: analysis and interpretation of data. PC, DE and FVdB: manuscript preparation. PC, DE and FVdB: manuscript revision.
Ackowledgements We thank all referring rheumatologist for the help in recruiting patients.
Funding This research was carried out as an Investigator Initiated Study with support from Janssen Pharmaceutica NV, who also provided the study medication.
Competing interests None declared.
Patient consent Obtained.
Ethics approval Medical Ethics Committee of the Ghent University Hospital.
Provenance and peer review Not commissioned; externally peer reviewed.
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