MADRID -- Most patients with early peripheral spondyloarthritis achieved remission during induction therapy with subcutaneous golimumab (Simponi), and were then able to withdraw from the anti-tumor necrosis factor inhibitor, a researcher reported here.
Among 60 patients enrolled in a study known as Clinical Remission in Early peripheral SPondyloArthritis (CRESPA), 49 were able to stop treatment with this tumor necrosis factor (TNF) inhibitor after maintaining sustained clinical remission at two major consecutive clinic visits, according to a report at the . Of those, 53% are still in drug-free remission after at least 12 months of follow-up, according to Philippe Carron, MD, of Ghent University in Belgium.
The number of patients who remained in drug-free clinical remission was "remarkably high," Carron said, noting that the longest drug-free follow-up is 4.5 years.
"Efficient treatment options are now available for peripheral spondyloarthritis, with most data coming from trials in psoriatic arthritis and ankylosing spondylitis. But one question remaining is how should we actually use these drugs? The fact is that little is known about the natural evolution of peripheral SpA, and there are some beliefs, particularly with reactive arthritis, that there may be high rates of spontaneous remission," he said.
Another question is whether or not there is actually a need for early, intensive treatment in this condition. Evidence has been accumulating for a "window of opportunity" for remission induction in the treatment of early rheumatoid arthritis. Because previous studies have suggested that treatment response is considerably greater in early axial disease, such a window may also exist for spondyloarthritis, with the possibility of treatment withdrawal following remission, he explained.
CRESPA is a single-center ongoing study evaluating golimumab for the treatment of peripheral SpA. Participants all had symptom duration of less than 12 weeks, and were randomized (2:1) to receive 50 mg of golimumab every 4 weeks or placebo for 24 weeks.
The primary endpoint was the percentage of patients in clinical remission at week 24. This required a complete absence of arthritis, enthesitis, and dactylitis. Concomitant nonsteroidal anti-inflammatory drugs were allowed, but disease-modifying anti-rheumatic drugs and corticosteroids were not.
Major clinical evaluations were performed at weeks 12, 24, 36, and 48.
Two-thirds of patients were men, and mean age was about 40. Mean symptom duration was 5 weeks. At baseline, peripheral arthritis was present in 59 of the 60 patients, while enthesitis and dactylitis were present in 25 and 24 patients, respectively. Tender and swollen joint counts were 5 and 4, respectively, and the most prominent extra-articular manifestation was psoriasis.
At week 24, 75% of the golimumab-treated patients were in clinical remission compared with only 20% of those receiving placebo (P<0.001). By week 12, similar results were already being seen with 70% versus 15% reaching clinical remission (P<0.001). Additional responses at week 12 included 40%, 50%, and 70% improvements from baseline, which were seen in 57.5%, 55%, and 50% of those in the golimumab group compared with 20%, 20%, and 15% of the placebo group.
A total of 47% of patients experienced a relapse after treatment withdrawal, with the mean time to relapse of 31 weeks.
"We also looked for baseline predictors of clinical remission, and only found that patients who had a swollen joint count more than 5 and also pre-existing psoriasis were not predictive of sustained clinical remission," he said.
The also were recently published. As early as week 12, clinical remission was reached by 70% of patients in the golimumab group compared with only 15% of those in the placebo group (P<0.001).
On the multi-component peripheral SpA remission criteria, improvements of 40%, 50%, and 70% were seen among 57.5%, 55%, and 50% of the golimumab group compared with 20% (P=0.007), 20% (P=0.013) and 15% (P=0.011) of the placebo group.
With regard to safety, there were no unexpected signals and the overall incidence of any adverse event was similar in the golimumab and placebo groups. The most common events in both groups were upper respiratory tract infection and nasopharyngitis.
Research questions remaining include what is the predictive value of imaging at baseline, and whether the early response is predictive of long-term remission, he concluded.
Disclosures
The authors reported no financial disclosures.
Primary Source
EULAR annual meeting
Carron P, et al "High drug-free remission in early peripheral spondyloarthritis after induction therapy with golimumab" EULAR 2017; abstract OP26.