Photo Credit: iStock.com/Christoph Burgstedt

The post-approval safety profile of cladribine tablets in relapsing MS was updated, with results consistent with development program findings and prior updates.

The post-approval safety profile of cladribine tablets in people with relapsing multiple sclerosis (MS) was updated. The results were consistent with findings from the clinical development program and previous safety updates. There was no increased risk of serious infections.

Adverse events (AEs) from post-approval sources were presented by Thomas Leist, MD, PhD, Jefferson University, Philadelphia, Pennsylvania.¹ The AE of special interest with the highest prevalence was hypersensitivity, which was reported 2,858 times. Of note, 98% of the 566 cases (674 AEs) in the latest reporting period (July 8, 2023-July 7, 2024) were nonserious. The second highest number of reports on AEs concerned serious infections; there were 1,270 reports of 1,584 serious infections in 101,132 patients with relapsing MS (rate, 0.50). The most frequently reported serious infections were pneumonia (11.9%; n=188), COVID-19 (10.3%; n=163), and urinary tract infection (10.0%; n=159). No treatment-associated progressive multifocal leukoencephalopathy (PML) was seen.

Other reported AEs of special interest, including the exposure-adjusted reporting rate per 100 patient-years, were the following:

• 830 reports of herpes zoster concerning 839 AEs (rate, 1.13).
• 623 reports of liver injury concerning 837 AEs (rate, 1.25). Of the 228 serious AEs, the most common were increased alanine aminotransferase (n=45) and increased aspartate aminotransferase (n=35).
• 397 reports of malignancies concerning 435 AEs (rate, 1.16). There was no pattern or clustering, and occurrence was in line with that expected in the general population.
• 259 reports of serious lymphopenia concerning 260 AEs (rate, 0.10); 69 cases were associated with infections.
• 106 reports of seizures (rate, 0.06).
• 39 reports of opportunistic infections other than tuberculosis (rate, 0.02); 23 were serious.
• 35 reports of tuberculosis (rate, 0.01).

A total of 474 pregnancies were identified, 200 with known outcomes. While the numbers are small, there was no evidence of an increased risk of adverse pregnancy outcomes among women receiving cladribine tablets.

Medical writing support was provided by Michiel Tent.
Copyright ©2025 Medicom Medical Publishers