AxSpA: Adalimumab biosimilar equally effective as IL-17 inhibitor in hindering radiographic progression

Radiographic progression in patients with axial spondyloarthritis (axSpA) was equally controlled by the IL-17A inhibitor secukinumab in comparison with the anti-TNF adalimumab biosimilar SDZ-ADL. At week 104, the efficacy of both treatment options was demonstrated by an overall low change from baseline in modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS).

“We report the very first head-to-head study in axSpA comparing secukinumab and adalimumab biosimilar with the aim of measuring any differences in radiographic progression,” Prof. Xenofon Baraliakos (Rheumazentrum Ruhrgebiet, Germany) announced [1]. The 2-year, phase 3b SURPASS study (NCT03259074) enrolled 859 biologic- naïve patients with active radiographic axSpA and a high risk of radiographic progress, with high-sensitivity C-reactive protein (hsCRP) ≥5 mg/L and/or the presence of at least 1 spinal syndesmophyte. The trial design foresaw 3 groups, receiving either adalimumab biosimilar SDZ-ADL 40 mg or secukinumab at 150 mg or 300 mg dosages as study treatment. The primary endpoint was defined as the proportion of participants without radiographic progression at week 104, measured by an mSASSS change from baseline ≤0.5 in the assessment of 3 different central readers.

Baseline demographics showed a mean age of 42.1, and 78.5% of the participants were men. The mean mSASSS was 16.6, the mean hsCRP was 20.4 mg/L, and 73% had ≥1 syndesmophyte. The results revealed similar and non-significant results for the primary endpoint across all groups, with rates of 66.1% (secukinumab 150 mg), 66.9% (secukinumab 300 mg), and 65.9% (SDZ-ADL) of participants not developing radiographic progression up to week 104. Additionally, respective mean values for change from baseline in mSASSS were low, at 0.54, 0.55, and 0.72, respectively, a fact that Prof. Baraliakos highlighted as an important message. In line with these results, the rates of participants without new syndesmophytes after 2 years ranged between 53.3% and 56.9%, without significant inter-group differences. The analysis furthermore did not find relevant dissimilarities in the reduction of oedema scores for the spine and sacroiliac joint.

“We did not observe any new safety signals; overall, about 80% of the participants had at least 1 adverse event, the most frequent being nasopharyngitis,” Prof. Baraliakos stated. For some specific adverse events, the exposure-adjusted incidence rates (EAIR) of secukinumab versus SDZ-ADL differed, among them Crohn’s disease (EAIR 1.0 vs 0.2) and uveitis (EAIR 2.1 vs 1.4).

“This first head-to-head prospective study in axSpA showed that radiographic progression of the spine over 2 years was low, with no significant difference between secukinumab and adalimumab biosimilar and no additional safety aspects besides the ones that we know well,” Prof. Baraliakos summarised. These interesting findings must be interpreted in the context of the inability to recognise rapid progressor patients, which are hard to define, and where such a comparative analysis cannot be performed.

1. Baraliakos Effect of secukinumab versus adalimumab biosimilar on radiographic progression in patients with radiographic axial spondyloarthritis: a randomized phase IIIB study. OP0059, EULAR 2023, 31 May–3 June, Milan, Italy.

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Posted on 31 July, 202331 July, 2023