SECUKINUMAB - AN OVERACHIEVER IN REAL-LIFE CLINICAL SETTING - HOW TO INTERPRET REAL WORLD EVIDENCE OF SECUKINUMAB IN SPONDYLOARTHRITIS
Abstract
The treat to target approach aims to attain remission or minimal disease activity in pacients with spondyloarthritis (SpA) or psoriatic arthritis (PsA). Secukinumab(SEK), an IL-17A inhibitor is of high use in anti-TNF fails or as first-line therapy when skin involvement is dominant. Primary outcome of the study was to evaluate response to SEK in bDMARD naïve and non-naïve AS and PsA patients in a real-world cohort. Secondary outcomes were SEK mean retention rate, adverse events occurance. A single-center observational, retrospective study was performed in AS and PsA patients started or switched on SEK, with a minimum follow-up period of six months. Outcome measures (BASDAI, ASDAS, inflammatory markers) were recorded at baseline and at the last follow-up visit. Statistical analysis used SPSS 20.0. Forty patients were included in the study, two discontinued treatment. Out of the 38 remaining patients, 9 had PsA and 29 SpA, mean age 54.6 and 49.75 respectively, with a slight male predominance (57.8% versus 42.1%). Mean disease duration was 108.4 months. 14 patients were started directly on SEK 150mg, while 24 were switched from a previous anti-TNF, ranging from one to five agents (12 non-responders, 12 adverse reactions). Pacients with PsA required a more frequent switch on SEK than patients with SpA. A drastic decrease in BASDAI score was observed in patients after they were started on SEK, from a mean value of 6.38 to 1.78, indicating an inactive disease at follow-up (p<0.0001). ASDAS-CRP decreased from a mean 4.12 to 1.67, classifying patients as having inactive to moderate disease (p<0.0001).In the PsA group the DAPSA score decreased with a mean of 26.1 points (p<0.0001) from 35.2 to 9.1 (p<0.0001).Likewise, C-reactive protein significantly decreased with a mean of 26 mg/dl at follow-up.
While there was no significant difference in BASDAI, the ASDAS-CRP mean difference confirmed benefit in patients who were first started on SEK compared to those with previous bDMARDs (-3.12 vs -2.21) p=0.08. Mean retention rate for SpA patients was 23.5 months, while for PsA patients it was 16.2 months (p=0.019). SEK survival rate was higher in patients with prior anti-TNF alpha therapy when compared to naïve-patients, with a value of 23.3 months versus 18.9, p 0.034.There was no difference in SEK drug survival as monotherapy versus combination with csDMARD (p 0.28). SEK was effective in lowering disease activity as proven by a reduction in clinical parameters and inflammatory markers showing prompt effect of the anti-IL17 agent.
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