Secukinumab Rapidly Improves Spinal Pain in Patients With Axial Spondyloarthritis

Secukinumab can effectively reduce spinal pain and improve disease activity measures as early as 8 weeks after starting treatment in patients with axial spondyloarthritis (axSpA), according to a study published in Therapeutic Advances in Musculoskeletal Disease.

A key symptom of axSpA is chronic back pain and patients with the disease often experience increased disease burden and limited performance of daily activities.

“Treatment strategies in axSpA aim to reduce inflammation, control signs, and symptoms, such as pain and stiffness, and prevent or delay the progression of structural damage in the spine that could result in preservation of functional status and improvements in quality of life (QoL) in the long term,” the authors explained.

First-line treatment is physical activity with nonsteroidal anti-inflammatory drugs, followed by biological disease-modifying anti-rheumatic drugs, such as secukinumab, an interleukin-17 inhibitor.

In a randomized, double-blinded, placebo-controlled, and multicenter study, SKIPPAIN, patients were randomized 3:1 to receive either secukinumab 150 mg (Group A) or placebo (Group B). There were 2 treatment periods in the SKIPPAIN: a double-blind, placebo-controlled period from baseline to week 8 (Treatment Period 1 [TP1]) and a double-blind secukinumab treatment period from week 8 to week 24 (Treatment Period 2 [TP2]).

Patients were re-randomized or re-assigned in TP2 to 1 of 5 treatment arms based on response in TP1:

• Responders from Group A who achieved an average spinal pain score of < 4 were re-assigned to A1 and continued with secukinumab 150 mg
• Non-responders were re-randomized to either secukinumab 150 mg in A2 or secukinumab 300 mg in A3
• Patients in Group B were re-randomized to either secukinumab 150 mg in B1 or secukinumab 300 mg in B2

A total of 380 patients were randomized. During TP1, 285 patients were in Group A (97.5% completed TP1) and 95 in Group B (93.7% completed TP1).

At the end of TP1, 31.9% of those in Group A responded to treatment compared with 20.0% in Group B. Odds of being a responder on the average spinal pain score and nocturnal pain score were higher for patients treated with secukinumab 150 mg vs placebo. As early as week 1, patients on secukinumab responded at higher rates compared with placebo (9.8% vs 2.1%).

At the end of TP2 there were improvements in pain scores observed across all treatment arms, but the patients who continued on secukinumab (A1) had the highest improvements for mean average pain score, total pain score, and nocturnal pain score. These patients also had the highest improvements in Bath Ankylosing Spondylitis Disease Activity Index score and Ankylosing Spondylitis Disease Activity Score.

The researchers also found:

1. In TP2, all treatment arms showed improvement in Functional Assessment of Chronic Illness Therapy-Fatigue score compared with baseline, although patients in A1 who continued on secukinumab 150 mg had the mean highest increase
2. At the end of TP2, all treatment arms had an improvement in Assessment of SpondyloArthritis international Society health index from baseline, although A1 again showed the highest mean improvement

The mean duration of exposure days was similar between the 2 groups in TP1 (29.0 days for secukinumab vs 28.7 days for placebo). Mean duration of exposure was similar across all 5 arms in TP2. Only 2.4% of patients experienced 1 or more serious adverse events (AEs). The most common AE was headache across all treatment arms followed by nasopharyngitis, oropharyngeal pain, and upper respiratory tract infection.

The results of the study highlighted that early identification of nonresponders may result in improved outcomes as a result of optimized treatment, the authors explained.

“In conclusion, the results of the SKIPPAIN trial demonstrated that secukinumab provided a rapid and significant improvement in spinal pain and reduced disease activity in patients with axSpA,” they wrote.

Reference

Poddubnyy D, Pournara E, Zielińska A, et al. Rapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-IIIb trial. Ther Adv Musculoskelet Dis. Published online October 22, 2021. doi:10.1177/1759720X211051471