Abstract Details

Title Comparing the Infectious and Neoplastic Adverse Event Profiles of Ocrelizumab and Cladribine Using the FDA Adverse Event Reporting Database

Topic Multiple Sclerosis

Presentation(s) P9 - Poster Session 9 (8:00 AM-9:00 AM)

Poster/Presentation
Number 6-009

Objective

To investigate the infectious and neoplastic adverse event (AE) profiles of ocrelizumab and cladribine for treatment of multiple sclerosis (MS) using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Background Ocrelizumab, an anti-CD20 monoclonal antibody, and cladribine, a purine nucleoside analog, are both considered high-efficacy disease modifying therapies for treating relapsing forms of MS. Their real-world safety profile, however, has not been adequately compared.

Design/Methods We performed a disproportionality analysis of the FAERS database between the first quarter of 2004 and the second quarter of 2023 using the OpenVigil2.1-MedDRA software. Preferred terms for common infectious and neoplastic AEs were extracted using MedDRA v.26. A signal was detected if the number of drug–AE reports was ≥3 and the proportional reporting ratio was ≥2 associated with a χ2 value of ≥4.

Results There were a total of 7,522 and 2,561 AE reports for ocrelizumab and cladribine, respectively. Among the most relevant infectious AEs, signals were detected for ocrelizumab for upper respiratory tract infections (URTI) (ROR [reporting odds ratio]:2.36; 95%CI:1.787-3.135), pneumonia (ROR:2.821; 95%CI:2.297-3.465), COVID-19 (ROR:31.889; 95%CI: 29.155-34.881), urinary tract infection (UTI) (ROR:2.055; 95%CI:1.846-2.289), and herpes virus infection (ROR:7.476; 95%CI:4.738-11.795). Similar analyses for cladribine detected signals for URTI (ROR:2.143; 95%CI:1.307-3.515), pneumonia (ROR:2.098; 95%CI:1.824-2.412), and COVID-19 (ROR:3.82; 95%CI:2.886-5.056), but not for UTI and herpes virus infection. No neoplastic safety signals were detected for ocrelizumab or cladribine regarding breast cancer, ovarian cancer, malignant melanoma, squamous cell or basal cell carcinoma, lung cancer and pancreatic cancer.

Conclusions This study showed differences in infectious AEs between cladribine and ocrelizumab, with infections appearing to be more frequently associated with ocrelizumab. However, no differences in neoplastic AE signals were noted. Overall, cladribine was not found to have a worse AE profile compared to ocrelizumab. Further longitudinal studies are needed to rigorously compare the real-world AE profile of ocrelizumab and cladribine.

Authors/Disclosures
Nasrin Rahimian, MD PRESENTER	Dr. Rahimian has nothing to disclose.
Olaf Stuve, MD, PhD, FAAN (UT Southwestern Medical Center)	Dr. Stuve has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Stuve has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Stuve has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Therapeutic Advances in Neurological Diseases. Dr. Stuve has received research support from US Department of Veterans Affairs. Dr. Stuve has received research support from National Multiple Sclerosis Society (US). Dr. Stuve has received research support from Merck KGaA.
Afsaneh Shirani, MD, FAAN	Dr. Shirani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics.

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