Le traitement par bimekizumab a été efficace à 2 ans, quelle que soit la durée des symptômes de l’axSpA : résultats de deux essais de phase III - 26/11/24
, L.S. Gensler 6, M. Kishimoto 7, V. Taieb 8, D. Voiniciuc 9, U. Massow 10, V. Navarro-Compán 11Résumé |
Introduction |
Bimekizumab (BKZ), an IgG1 monoclonal antibody that selectively inhibits IL-17F in addition to IL-17A, has shown efficacy through week (W) 52 in patients (pts) with non-radiographic/radiographic axial spondyloarthritis (nr-/r-axSpA) in two phase III trials [1]. We compare the impact of symptom duration on the efficacy of BKZ at 2 years.
Patients et méthodes |
In BE MOBILE 1 (nr-axSpA; NCT03928704) and 2 (r-axSpA; NCT03928743), pts were randomized to BKZ or placebo (PBO); all received BKZ from W16 to W52. At W52, pts could enter the open-label extension study (NCT04436640) and receive BKZ. We present results through W104 for pts with a duration of symptoms (DoS) ≤2/>2 years (ASAS definition of early axSpA) [2], and ≤5/>5 years to optimize subgroup sizes. Pts who received continuous BKZ and those who switched from PBO to BKZ were pooled from W52.
We present ASAS40 (non-responder imputation), ASDAS<2.1, and change from baseline in BASDAI (CfB; multiple imputation) for pts with DoS ≤5/>5 (BE MOBILE 1 and 2) and ≤2/>2 (BE MOBILE 1), mean SPARCC score on sacroiliac joint MRI (observed cases) for pts with DoS ≤5/>5 in BE MOBILE 1. To compare the efficacy of BKZ vs PBO according to DoS, we calculated relative odds ratios (ASAS40/ASDAS<2.1) and relative differences (BASDAI CfB/SPARCC) at W16, if sample size allowed.
Résultats |
Better outcomes were observed with BKZ vs. PBO at W16, regardless of DoS. Results were maintained/improved through W104. At W16, more BKZ-treated pts with DoS ≤5/≤2 achieved ASAS40/ASDAS<2.1 compared with patients with DoS>5/>2, respectively. No significant differences were detected between DoS≤5/>5 (BE MOBILE 1 and 2) or between DoS≤2/>2 (BE MOBILE 1). At W104, more pts with DoS≤5/≤2 achieved ASAS40/ASDAS<2.1 (Figure 1, Figure 2).
No significant relative difference in mean BASDAI CfB between DoS≤5/>5 or ≤2/>2 was detected at W16 in BE MOBILE 1, but a greater improvement was seen in BASDAI in pts with DoS≤5 vs.>5 in BE MOBILE 2. Improvements in mean BASDAI were greater at W104 in pts with DoS≤5/≤2 vs>5/>2, respectively (Figure 3).
Baseline SPARCC scores indicated greater inflammation in pts with DoS≤5 vs>5. BKZ treatment resulted in a reduction in mean SPARCC scores at W16; compared with PBO, no significant difference was detected between DoS≤5/>5 in BE MOBILE 1 (relative difference [95% CI]: –3.10 [–8.09, 1.90]). Mean SPARCC scores remained low through W104 (DoS≤5: 2.03 [n=40], DoS>5: 2.83 [n=55]) and indicated resolution of inflammation, regardless of DoS.
Conclusion |
BKZ treatment was effective at 2 years, regardless of symptom duration, with no difference observed in treatment effect at W16 between pts with shorter symptom duration and those with longer symptom duration.
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Vol 91 - N° S1
P. A206-A208 - décembre 2024 Retour au numéro
Article précédent
- Impact du rhumatisme psoriasique récent oligoarticulaire selon le questionnaire PSAID-12 (Psoriatic Arthritis Impact of Disease 12-items) dans l’étude FOREMOST de l’aprémilast
- L. Gossec, L.C. Coates, D.D. Gladman, A. Ogdie, P. Nash, D. Poddubnyy, A. Kavanaugh, A. Armstrong, C. Selmi, R. Queiro, C. Deignan, R. Wang, J. Reddy, M. Brunori, P.J. Mease
- Le bimekizumab a maintenu les réponses d’efficacité chez les patients atteints de rhumatisme psoriasique actif : résultats à 2 ans de deux études de phase III
- L. Gossec, J.A. Walsh, J.F. Merola, C.T. Ritchlin, Y. Tanaka, E.G. Favalli, D. McGonagle, D. Thaçi, B. Ink, R. Bajracharya, J. Coarse, W. Tillett
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