Secukinumab and Sandoz Adalimumab Have Similar Outcomes When Treating r-axSpA

Xenofan Baraliakos, MD

Credit: ResearchGate

A new study found patients with radiographic axial spondyloarthritis (r-axSpA) treated with secukinumab (IL-17A inhibitor) and the biosimilar Sandoz adalimumab (SDZ-ADL; TNF inhibitor) had no significant differences in the effectiveness of the treatment.¹

“SURPASS is, to date, the only head-to-head randomized study evaluating the effect of two biologic treatments on radiographic progression in a high-risk r-axSpA population,” wrote investigators, led by Xenofan Baraliakos, MD, from Ruhr-University Bochum in Germany.

Separate trials for secukinumab and Sandoz adalimumab showed the treatments can improve symptoms of r-axSpA and both were linked to low rates of radiographic progression.^2,3 Secukinumab and Sandoz adalimumab are both approved by the US Food and Drug Administration (FDA) to treat r-axSpA. However, the two treatments were never compared to see which one had a lower rate of radiographic progression.₁

The new study, SURPASS, compared the changes in spinal radiographic progression—an important outcome in r-axSpA—in the treatments of secukinumab and SDZ-ADL. The randomized, partially blinded, active-controlled, parallel-group, multicenter study was conducted in 171 centers worldwide.

Participants (n = 859; 78.5% male) were ≥ 18 years old, met the modified New York classification criteria for AS, had moderately to severely active disease, no prior history of bDMARD, and were all biologic-naïve and had active r-axSpA at a high risk of radiographic progression defined as a high-sensitivity C-reactive protein ≥ 5 mg/L or ≥ 1 syndesmophyte[s] on spinal radiographs. To be eligible, patients needed a score of ≥ 4 on the Bath AS Disease Activity Index (BASDAI; range: 0 – 10), a spinal pain score of ≥ 4 (range 0 – 10), and a total back pain score of ≥ 40 mm on a 100 mm visual analog scale (VAS).

Patients were randomized 1:1:1 to secukinumab at either 150 (n = 287) or 300 mg (n = 300), or SDZ-ADL at 40 mg (n = 286). They were given secukinumab at baseline (weeks 1, 2, 3, and 4) and from there every 4 weeks until week 100. SDZ-ADL was administered at baseline and every 2 weeks until week 102.

The primary endpoint was the number of patients with no radiographic progression, indicated by a change from baseline in modified Stroke Ankylosing Spondylitis Spinal Cord Score ≤ .05 at week 104, to demonstrate the superiority of secukinumab over SDZ-ADL. Investigators also assessed the mean change from baseline in the Stroke Ankylosing Spondylitis Spinal Cord Score, the proportion of patients with ≥ 1 syndesmophyte(s) at baseline with no new syndesmophytes(s), and safety.

At baseline, participants had a mean Stroke Ankylosing Spondylitis Spinal Cord Score of 16.1, a high sensitivity C-reactive protein of 20.4 mg/L, and 73% with ≥ 1 syndesmophytes. At week 104, the proportion of patients with no radiographic progression for those receiving secukinumab 150 mg, secukinumab 300 mg, or SDZ-ADL was 66.1%, 66.9%, and 65.6%, respectively. However, the data was not significant.

Therefore, the findings did not reveal secukinumab was superior to SDZ-ADL in terms of how many patients had no radiographic progression. Due to the nonsignificant data, the statistical testing ended.

The mean change from baseline Stroke Ankylosing Spondylitis Spinal Cord Score was 0.54 for secukinumab 150 mg, 0.55 for secukinumab 300 mg, and 0.72 for SDZ-ADL, showing no notable difference across groups.

Furthermore, about half of the patients who had ≥ 1 syndesmophyte(s) at baseline did not develop new syndesmophyte(s) by the of the study, which was 56.9% for secukinumab 150 mg, 53.8% for secukinumab 300 mg, and 53.3% for SDZ-ADL.

Investigators also measured ASAS 20 and ASAS 40 response rates at week 104 and found they were 83.1% and 69.9% in the secukinumab 150 mg group and 82.9% and 73.5% in the secukinumab 300 mg group, respectively. Responses rates for SDZ-ADL groups were similar.

As for the safety comparison, only 14% (secukinumab 150 mg), 10.2% (secukinumab 300 mg), and 11.2% (SDZ-ADL) of patients had ≥ 1 serious adverse event. The most common adverse event was nasopharyngitis, occurring in 16.4%, 14.0%, and 15.4% in the secukinumab 150 mg, 300 mg, and SDZ-ADL groups, respectively. Investigators observed similar adverse events between secukinumab and SDZ-ADL, except for Crohn’s disease, ulcerative colitis, uveitis, and pulmonary tuberculosis. The team observed Crohn’s disease, ulcerative colitis, and uveitis in the secukinumab groups and pulmonary tuberculosis in the SDZ-ADL group.

“The SURPASS study did not meet the primary endpoint of demonstrating superiority of secukinumab over SDZ-ADL in terms of the proportion of patients with no radiographic regression treatments, with no significant difference between treatment arms,” investigators concluded. “There were no new safety signals for either therapy.”

^References

1. ^{Baraliakos X, Østergaard M, Poddubnyy D, et al. Effect of secukinumab versus adalimumab biosimilar on radiographic progression in patients with radiographic axial spondyloarthritis: Results from a head-to-head randomized phase IIIb study. Arthritis Rheumatol. Published online March 31, 2024. doi:10.1002/art.42852}
2. ^{Braun J, Kiltz U, Bühring B, Baraliakos X. Secukinumab in axial spondyloarthritis: a narrative review of clinical evidence. Ther Adv Musculoskelet Dis. 2021;13:1759720X211041854. Published 2021 Aug 28. doi:10.1177/1759720X211041854}
3. ^{Ward MM, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 2019;71(10):1285-1299. doi:10.1002/acr.24025}