CONFIDENCE treatment success: Long-term real-world effectiveness and safety of ocrelizumab in Germany

Mathias Buttmann^1*Martin S Weber^2,3Sven G Meuth⁴Sandra Blümich⁵Stefanie Hieke-Schulz⁵Petra Dirks⁶Julius C Eggebrecht⁵Tjalf Ziemssen⁷

• ¹Caritas-Krankenhaus, Bad Mergentheim, Germany
• ²Department of Neuropathology, University Medical Center Göttingen, Göttingen, Lower Saxony, Germany
• ³Fraunhofer-Institute for Translational Medicine and Pharmacology ITMP, Göttingen, Germany, Göttingen, Germany
• ⁴Department of Neurology, University Clinic Düsseldorf, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany, Düsseldorf, Germany
• ⁵Roche Pharma AG, Grenzach-Wyhlen, Germany, Grenzach-Wyhlen, Germany
• ⁶F. Hoffmann-La Roche AG, Basel, Switzerland, Basel, Switzerland
• ⁷Center of Clinical Neuroscience, Neurological Clinic, Carl Gustav Carus University Clinic, University of Technology, Dresden, Germany, Dresden, Germany

Background: Early high-efficacy treatment of people with relapsing multiple sclerosis (pwRMS) may provide better long-term outcomes compared with the escalation strategy. Here, we present an analysis of CONFIDENCE treatment success and safety in a real-world cohort of pwRMS treated with ocrelizumab in different treatment lines for up to 5.5 years.: The ongoing German non-interventional post-authorization safety study CONFIDENCE (ML39632, EUPAS22951) evaluates the long-term safety and effectiveness of therapy in pwMS newly treated with ocrelizumab or other disease-modifying therapies for up to 10 years. This analysis presents CONFIDENCE treatment success (proportion of people with no clinical disease activity measured by relapse or disease progression and no treatment discontinuation due to adverse event [AE] or lack of therapeutic effectiveness), confirmed disability progression (CDP), annualized relapse rates, and safety in pwRMS stratified by the number of previous MS therapies (PMSTs). Results: At data cutoff (11 Oct 2023), the full analysis set included 2,261 pwRMS treated with ≥1 dose of ocrelizumab. At baseline, mean age (SD) was 41.16 (11.39) years (treatment-naïve, 39.19 [12.95] years; ≥3 PMSTs, 42.80 [10.08] years) and mean EDSS was 3.08 (1.86) (treatment-naïve, 2.37 [1.54]; ≥3 PMSTs , 3.57 [1.90]). Overall, 58.4% of pwRMS with continuous treatment achieved CONFIDENCE treatment success from baseline until year 5 (74.0 and 50.3% of pwRMS with 0 and ≥3 PMSTs). Reasons for not achieving CONFIDENCE treatment success were mostly relapse and CDP, and only to a small extent discontinuation due to AEs or lack of effectiveness. The proportion of pwRMS with AEs did not increase with increased treatment duration and tended to be higher with a higher number of PMSTs. The spectrum of AEs was similar across treatment lines and no new or unexpected AEs were observed.CONFIDENCE treatment success was high over 5 years of ocrelizumab treatment, also in pwRMS with a higher number of PMSTs. Only a small proportion of pwRMS discontinued treatment due to AEs. These results support the early intervention with high-efficacy ocrelizumab treatment to optimize long-term outcomes for pwRMS.