medwireNews: Secukinumab significantly reduces spinal pain in patients with axial spondyloarthritis (axSpA), with benefits seen after just 8 weeks, findings from the SKIPPAIN trial show.
Researcher Denis Poddubnyy (Charité University Hospital, Berlin, Germany), who presented the findings in a poster at the ACR Convergence 2020 virtual meeting, also noted that there was a significant improvement in disease activity with the interleukin-17A inhibitor and the clinical benefits were sustained or improved further up to week 24.
Discussing the rationale for the phase 3b trial, he pointed out that “clinical studies routinely use composite measures of disease activity to assess treatment effect, despite pain being the most troubling symptom for patients.”
Denis Poddubnyy on SKIPPAIN: axSpA spinal pain relief with secukinumab
Poddubnyy reported that in their trial, 32% of 285 patients with axSpA who were randomly assigned to receive subcutaneous secukinumab 150 mg every 4 weeks for 24 weeks, following a loading dose of 150 mg/week from week 0–4, responded to treatment achieving a spinal pain numerical rating scale (NRS) score below 4 points on a scale of 0–10 by week 8.
These patients were a significant 1.9-fold more likely to respond to treatment than the 95 patients assigned to placebo, among whom the response rate was 20%.
The total spinal pain NRS score fell from an average of 7.23 points before secukinumab treatment to 4.67 points at week 8, compared with a decrease from 7.22 to 5.77 points with placebo.
Among the patients, 70.8% had radiographic axSpA and 29.2% had non-radiographic axSpA. The average BASDAI score at baseline was 7.0 points and all of the participants had failed to respond adequately to at least two nonsteroidal anti-inflammatory drugs for at least 4 weeks prior to the trial.
At the 8-week follow-up, the patients confirmed as responders were randomly re-assigned to start or continue secukinumab 150 mg treatment for a further 16 weeks, while nonresponders were randomly re-assigned to receive secukinumab 150 mg or an up-titrated dose of 300 mg every 4 weeks for 16 weeks.
“The secukinumab up-titration strategy might be beneficial for suboptimal responders to secukinumab 150 mg,” said Poddubnyy.
Indeed, 48% of 94 patients who had not responded to secukinumab 150 mg in the first 8 weeks had done so with secukinumab 300 mg by week 24. The responder rates for the other treatment arms were 86% for patients who responded and continued with secukinumab 150 mg, 43% for nonresponders assigned to secukinumab 150 mg, and 58% and 68% for patients who originally received placebo and were re-assigned to secukinumab 150 mg and 300 mg, respectively.
Poddubnyy commented that “pronounced improvements” in disease activity were also observed, as measured on the ASDAS-CRP, and that a numerically higher proportion of patients achieved ASDAS-CRP low disease activity at week 24 after dose escalation to 300 mg compared with those who continued on the 150 mg dose.
The safety profile of secukinumab was consistent with that previously reported, with no new or unexpected safety signals, said Poddubnyy.
Any adverse events of special interest, such as ulcerative colitis and uveitis, occurred at exposure-adjusted incidence rates per 100 patient–years of 1.4 or below. The rate of serious adverse events was 2.4% and there were no deaths.
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