Background/Purpose: To evaluate drug-free sustained clinical remission and clinical relapse after induction therapy with golimumab in patients with active peripheral Spondyloarthritis (pSpA) in a very early stage of the disease. The hypothesis would be that treatment with a TNF-blocker at this early (“immature”) stage of the disease would result in a significant higher number of patients in clinical remission compared to placebo.

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. If patient were in clinical remission at two major consecutive visits planned at week 12 and 24, treatment was stopped. These patients were prospectively followed to assess the percentage of patients in drug-free sustained clinical remission or having a clinical relapse of arthritis, dactylitis and enthesitis. In case of clinical relapse patients were retreated with open-label golimumab in the extension part of this trial.

Results: In total 60 patients were randomized of whom 20 received placebo and 40 golimumab. Baseline demographics and disease characteristics were generally similar between the 2 groups. At week 24 a significantly 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 ). Sustained clinical remission (both at week 12 and 24) was observed in 67.5% (27/40) of golimumab treated patients, compared to only 15% (3/20) in the placebo group; in these patients treatment was stopped. All patients had at least a follow up of 6 months after discontinuation of treatment with a maximum of 52 months. 60% (18/30) of these patients are still in drug-free sustained clinical remission and 40% (12/30) had a clinical relapse. In the 12 patients with relapse after withdrawal of treatment, 10 patients (83.3%) already experienced this flare within 6 months of discontinuation.

Conclusion: In patients with active, very early peripheral spondyloarthritis, treatment with golimumab led to high percentages of clinical remission at week 12 and 24. A high percentage of patients stayed in sustained drug-free clinical remission after induction therapy with golimumab the first 24 weeks.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/exploring-the-window-of-opportunity-for-drug-free-clinical-remission-in-patients-with-active-very-early-peripheral-spondyloarthritis/