Universität zu Köln

Ellwardt, Erik, Rolfes, Leoni, Klein, Julia, Pape, Katrin, Ruck, Tobias, Wiendl, Heinz, Schroeter, Michael, Zipp, Frauke, Meuth, Sven G., Warnke, Clemens and Bittner, Stefan (2020). Ocrelizumab initiation in patients with MS A multicenter observational study. Neurol.-Neuroimmunol. Neuroinflammation, 7 (4). PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 2332-7812

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Abstract

Objective To provide first real-world experience on patients with MS treated with the B cell-depleting antibody ocrelizumab. Methods We retrospectively collected data of patients who had received at least 1 treatment cycle (2 infusions) of ocrelizumab at 3 large neurology centers. Patients' characteristics including premedication, clinical disease course, and documented side effects were analyzed. Results We could identify 210 patients (125 women, mean age +/- SD, 42.1 +/- 11.4 years) who had received ocrelizumab with a mean disease duration of 7.3 years and a median Expanded Disability Status Scale score of 3.75 (interquartile range 2.5-5.5; range 0-8). Twenty-six percent of these patients had a primary progressive MS (PPMS), whereas 74% had a relapsing-remitting (RRMS) or active secondary progressive (aSPMS) disease course. Twenty-four percent of all patients were treatment naive, whereas 76% had received immune therapies before. After ocrelizumab initiation (median follow-up was 200 days, range 30-1,674 days), 13% of patients with RRMS/aSPMS experienced a relapse (accounting for an annualized relapse rate of 0.17, 95% CI 0.10-0.24), and 5% of all patients with MS experienced a 12-week confirmed disability progression. Treatment was generally well tolerated, albeit only short-term side effects were recorded, including direct infusion-related reactions and mild infections. Conclusions We provide class IV evidence that treatment with ocrelizumab can stabilize naive and pretreated patients, indicating that ocrelizumab is an option following potent MS drugs such as natalizumab and fingolimod. Further studies are warranted to confirm these findings and to reveal safety concerns in the longer-term follow-up. Classification of evidence This study provides Class IV evidence that for patients with MS, ocrelizumab can stabilize both treatment-naive and previously treated patients.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Ellwardt, Erik UNSPECIFIED UNSPECIFIED UNSPECIFIED Rolfes, Leoni UNSPECIFIED UNSPECIFIED UNSPECIFIED Klein, Julia UNSPECIFIED UNSPECIFIED UNSPECIFIED Pape, Katrin UNSPECIFIED UNSPECIFIED UNSPECIFIED Ruck, Tobias UNSPECIFIED UNSPECIFIED UNSPECIFIED Wiendl, Heinz UNSPECIFIED UNSPECIFIED UNSPECIFIED Schroeter, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Zipp, Frauke UNSPECIFIED UNSPECIFIED UNSPECIFIED Meuth, Sven G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Warnke, Clemens UNSPECIFIED UNSPECIFIED UNSPECIFIED Bittner, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-327391
DOI:	10.1212/NXI.0000000000000719
Journal or Publication Title:	Neurol.-Neuroimmunol. Neuroinflammation
Volume:	7
Number:	4
Date:	2020
Publisher:	LIPPINCOTT WILLIAMS & WILKINS
Place of Publication:	PHILADELPHIA
ISSN:	2332-7812
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language MULTIPLE-SCLEROSIS; RITUXIMAB; FINGOLIMOD; PLACEBO; NATALIZUMAB Multiple languages Clinical Neurology; Neurosciences Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/32739