Comparative effectiveness of ocrelizumab in subgroups of patients with multiple sclerosis: a multi-registry observational cohort study.
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Roos Izanne, Sharmin Sifat, Horakova Dana, Kubala Havrdova Eva, Libertinova Jana, Vachova Marta, Alroughani Raed, Boz Cavit, Rous Zuzana, Buzzard Katherine, Skibina Olga, Peterka Marek, Hradilek Pavel, Mares Miroslav, Coles Alasdair, Brown J William L, Eichau Madueño Sara, Foschi Matteo, Prevost Julie, Terzi Murat, Prat Alexandre, Girard Marc, Meca-Lallana Jose E, John Nevin, Blanco Yolanda, van der Walt Anneke, Butzkueven Helmut, Recmanova Eva, Laureys Guy, Ampapa Radek, Macdonell Richard, Pavelek Zbysek, Khoury Samia Joseph, D'Amico Emanuele, Gerlach Oliver, Van Pesch Vincent, Maimone Davide, Romero-Ferrando Beatriz, McCombe Pamela A, Mrabet Saloua, Willekens Barbara, Cárdenas-Robledo Simón, Ramo-Tello Cristina, Stourac Pavel, Houskova Jana, Shaygannejad Vahid, Hodgkinson Suzanne, Cartechini Elisabetta, Kermode Allan G, Fabis-Pedrini Marzena, Carroll William M, Slee Mark, Sánchez-Menoyo José Luis, Al-Asmi Abdullah, Mathey Guillaume, Giannesini Claire, Michel Laure, Ciron Jonathan, De Sèze Jérôme, Ruet Aurelie, Kwiatkowski Arnaud, Zephir Helene, Papeix Caroline, Lebrun-Frenay Christine, Moreau Thibault, Berger Eric, Clavelou Pierre, Pelletier Jean, Casez Olivier, Bourre Bertrand, Wahab Abir, Magy Laurent, Camdessanché Jean-Philippe, Doghri Ines, Tchikviladze Maia, Sellebjerg Finn, Romme Christensen Jeppe, Jensen Henrik Boye, Illes Zsolt, Bramow Stephan, Rasmussen Peter V, Stilund Morten Leif, Schäfer Jakob, Kant Matthias, Weglewski Arkadiusz, Vukusic Sandra, Magyari Melinda, Laplaud David-Axel, Kalincik Tomas, MSBase, OFSEP and Danish MS Registries
Аннотация
METHODS: Patients with relapse-onset MS treated with ocrelizumab, fingolimod, natalizumab or alemtuzumab for ≥6 months were identified from three registries: MSBase, OFSEP and Danish MS Registry. Pairwise comparisons were performed in the overall cohort and 14 predefined clinicodemographic subgroups based on sex, disease activity, MS duration, Expanded Disability Status Scale, prior therapy and reason for prior treatment cessation. Relapses, progression independent of relapse activity (PIRA) and relapse-associated worsening (RAW) were compared in pairwise-censored groups.
RESULTS: Fingolimod was associated with a higher annualised relapse rate (ARR) (0.14 vs 0.06, p<0.001), relapse risk (HR 2.26, 95% CI 1.98 to 2.58), RAW (1.62, 1.08 to 2.43) and lower risk of disability improvement (0.78, 0.63 to 0.96) than ocrelizumab. Superiority of ocrelizumab over fingolimod on relapses was maintained in all subgroups. Natalizumab was associated with marginally higher ARR (0.10 vs 0.07, p<0.001), relapse risk (1.35, 1.16 to 1.57) and RAW (1.77, 1.07 to 2.94) than ocrelizumab. Alemtuzumab was associated with higher ARR (0.18 vs 0.12, p<0.001) and relapse risk (1.48, 1.25 to 1.76) than ocrelizumab, but there was no evidence for a difference in risk of RAW. There was no evidence for a difference on PIRA in any comparisons. Ocrelizumab was superior to natalizumab and alemtuzumab on relapses in patients who were not treatment-naïve, experienced disease activity on the prior therapy or stopped prior therapy due to lack of efficacy.
CONCLUSIONS: Ocrelizumab provides superior control of relapses and RAW, especially among patients with prior on-treatment disease activity. Treatment of PIRA remains an unmet need.