Abstract
Background Data regarding effectiveness and persistence to therapy with anti-IL17 agent secukinumab (SEC) in spondyloarthritis (SpA) patients of real world clinical practice are very limited. Objectives To assess characteristics of SpA patients starting therapy with SEC versus tumor necrosis factor inhibitors (TNFis) in routine clinical care and compare clinical responses and treatment retention at 2 years. Methods All patients starting a bDMARD in the Rheumatology Department of the University Hospital of Heraklion, Crete, are included in a prospective observational study after their written informed consent. Data concerning disease activity at pre-specified time-points, drugs, comorbidities and any adverse events are recorded. For the present study we analyzed all consecutive patients with axial (AxSpA) or peripheral SpA (pSpA) starting or switching bDMARD therapy, either a TNFi or SEC from 1/2015 till 12/2018. We excluded patients with IBD-related SpA, patients starting ustekinumab (or apremilast) and patients switching from a bio-originator to a biosimilar TNFi. We compared disease activity scores improvement at 6 months using linear regression analysis and treatment retention using Kaplan-Meier survival curves with log-rank test and Cox regression. Inverse propensity score weighting (IPW) was used to adjust for the potential confounding of gender, age, disease duration, previous bDMARDs and csDMARDs number, diagnosis (AxSpA vs pSpA), presence of peripheral arthritis and co-therapy with csDMARDs. Results A total of 239 patients with SpA started/switched bDMARD (SEC:69, TNFis:170). SEC was the ≥3rd bDMARD in 63% of patients compared to 17% of TNFis (p Unadjusted 2-year treatment retention was similar in the two groups, both overall (SEC: 63%, TNFi: 56%, p=0.18) and due to failure or adverse events. However, when we selected only patients on 1st or 2nd bDMARD (SEC:26, TNFis:131), 2-year survival of SEC was higher than that of TNFis (95% vs. 57%, p=0.027). Similarly, SEC tended to have higher survival than TNFis in patients with pSpA (p=0.11). After IPW, SEC administration was an independent predictor for higher bDMARD retention overall [HR (95%CI)=0.48(0.33-0.69), p Mean BASDAI and ASDAS improvements at 6 months were similar in patients with AxSpA receiving SEC or TNFis [Mean(SD) δBASDAI: 1.6 (2.5) vs 1.4(2.5) respectively (p=0.78) and δASDAS: 0.7 (1.4) vs 1.0 (1.5), p=0.44]. Similarly, in patients with peripheral arthritis, δDAS28 at 6 months was comparable in the two groups (p=0.88). Adjusted linear regression with IPW provided similar results to the unadjusted analyses in both axial and peripheral disease. Conclusion In SpA patients of real-world, administration of SEC results in similar clinical responses but higher treatment adherence compared to TNFis, especially if Secukinumab is the 1st or 2nd bDMARD. Larger number of patients and longer follow-up is needed to confirm these data. Disclosure of Interests None declared
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