Clinical and epidemiological correlates of treatment change in patients with NMOSD: insights from the CIRCLES cohort

Author:

Gholizadeh Shervin,Exuzides Alex,Lewis Katelyn E.,Palmer Chella,Waltz Michael,Rose John W.,Jolley Anna Marie,Behne Jacinta M.,Behne Megan K.,Blaschke Terrence F.,Smith Terry J.,Sinnott Jennifer,Cook Lawrence J.,Yeaman Michael R.,Aguerre Ines,Amezcua Lilyana,Chitnis Tanuja,Lewis Jessica Coleman,Engel Casey,Han May H.,Klawiter Eric C.,Kocsik Alexandra,Kruse-Hoyer Mason,Levine Libby,Levy Michael,Marcille Melanie,Mealy Maureen A.,Moore Stephanie,Mullin Devin S.,Nelson Katherine E.,Onomichi Kaho B.,Planchon Sarah M.,Pruitt Ana,Repovic Pavle,Riley Claire S.,Rimler Zoe,Russo Andrew W.,Ocampo Collin Tanchanco,Tomczak Anna J.,

Abstract

Abstract Objective Neuromyelitis optica spectrum disorders (NMOSD) represent rare autoimmune diseases of the central nervous system largely targeting optic nerve(s) and spinal cord. The present analysis used real-world data to identify clinical and epidemiological correlates of treatment change in patients with NMOSD. Methods CIRCLES is a longitudinal, observational study of NMOSD conducted at 15 centers across North America. Patients with ≥ 60 days of follow-up and receiving on-study maintenance treatment were evaluated. The mean annual relapse rate (ARR) was estimated using negative binomial models; the likelihood of treatment change was estimated using Cox proportional hazards models. Relapses were included as time-varying covariates to estimate the relationship to treatment change. Results Of 542 patients included, 171 (31.5%) experienced ≥ 1 relapse on the study and 133 patients (24.5%) had ≥ 1 change in the treatment regimen. Two categories of variables significantly correlated with the likelihood of treatment change: (1) relapse: any on-study relapse (hazard ratio [HR] = 2.91; p < 0.001), relapse phenotypes (HR range = 2.15–5.49; p < 0.001), and pre-study ARR > 0.75 (HR 2.28; p < 0.001); 2) disease phenotype: brain syndrome only vs transverse myelitis involvement at onset (HR 2.44; p = 0.008), disease duration < 1 vs > 5 years (HR 1.66; p = 0.028), or autoimmune comorbidity (HR 1.55; p = 0.015). A subset of these factors significantly correlated with shorter time to first rituximab discontinuation. Conclusions In CIRCLES, relapse patterns and disease phenotype significantly correlated with changes in the maintenance treatment regimen. Such findings may facilitate the identification of patients with NMOSD who are likely to benefit from treatment change to reduce relapse risk or disease burden and enhance the quality of life.

Funder

Genentech

Publisher

Springer Science and Business Media LLC

Subject

Neurology (clinical),Neurology

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