EFFECT OF SECUKINUMAB VERSUS ADALIMUMAB BIOSIMILAR ON RADIOGRAPHIC PROGRESSION IN PATIENTS WITH RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS: A RANDOMIZED PHASE IIIB STUDY
Authors: Xenofon Baraliakos et al.
Clinical efficacy of biologics, TNF-inhibitors as well as IL-17-inhibitors, in the treatment of axial spondyloarthritis is well documented. However, whether the radiographic progression is effectively slowed is less clear. Data from observational studies, including data from the SCQM, suggest that TNF-inhibitor therapy has an inhibitory effect on radiographic progression. This randomized partially blinded study compared the radiographic progression of patients treated with secukinumab or with an adalimumab biosimilar in a head to head design. To be included patients had to have radiographic axSpA with a BASDAI ≥4, spinal pain ≥4, total back pain score ≥40 (0-100) and either a hsCRP ≥5 or ≥1 syndesmophyte on spinal X-ray. The primary endpoint was the proportion of patients with no radiographic progression (mSASSS ≤0.5) at week 104. The patients had a high mean disease activity (BASDAI 7.1) and 73% had ≥1 syndesmophyte, representing a population with a high risk for radiographic progression. The proportions of patients at week 104 with no radiographic progression were 66.1% in the secukinumab 150mg, 66.9% in the secukinumab 300mg and 65.6% in the adalimumab group, the differences were not statistically significant. Similarly, the change of the mSASSS until week 104 was not different between the groups, as well as the percentages of patients that had syndesmophytes at baseline and did not develop new syndesmophytes by week 104.
This study is remarkable as it is a head to head study of two biologics with radiographic progression as a primary outcome. Although a population with a high risk of radiographic progression was included in the study, the measured radiographic progression was low. There were no differences between secukinumab and adalimumab, indicating that secukinumab has similar effects on radiographic progression compared to adalimumab. It has to be noted that, although the low radiographic progression seen in this trial suggests that radiographic progression was inhibited, this cannot be firmly concluded due to the lack of a control group without bDMARD treatment. The study extends the existing data on clinical efficacy and safety of secukinumab in axSpA documenting equal effects on structural changes compared to a TNF-inhibitor in a head to head design.