Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223

Abstract

Background In the phase 2 CAMMS223 trial (NCT00050778), alemtuzumab significantly improved clinical and MRI outcomes versus subcutaneous interferon beta-1a over 3 years in treatment-naive patients with relapsing–remitting MS. Here, we assess efficacy and safety of alemtuzumab over 12 years in CAMMS223 patients who enrolled in the CAMMS03409 extension (NCT00930553), with available follow-up through the subsequent TOPAZ extension (NCT02255656). Methods In CAMMS223, patients received 2 alemtuzumab courses (12 mg/day; baseline: 5 days; 12 months later: 3 days); 22% received a third course. In the open-label, nonrandomized extensions, patients could receive as-needed additional alemtuzumab or other disease-modifying therapies. Results Of 108 alemtuzumab-treated patients in CAMMS223, 60 entered the CAMMS03409 extension; 33% received a total of 2 alemtuzumab courses, and 73% received no more than 3 courses through Year 12. Over 12 years, annualized relapse rate was 0.09, 71% of patients had stable or improved Expanded Disability Status Scale scores, and 69% were free of 6-month confirmed disability worsening. In Year 12, 73% of patients were free of MRI disease activity. Cumulatively throughout the extensions (Years 7–12), 34% of patients had no evidence of disease activity. Adverse event (AE) incidence declined through Year 12. Infusion-associated reactions peaked at first course and declined thereafter. Cumulative thyroid AE incidence was 50%; one immune thrombocytopenia event occurred, and there were no autoimmune nephropathy cases. Conclusions Alemtuzumab efficacy was maintained over 12 years in CAMMS223 patients, with 73% receiving no more than three courses. The safety profile in this cohort was consistent with other alemtuzumab clinical trials.

Anti-CD52 Therapy for Multiple Sclerosis: An Update in the COVID Era

“…That might cause a selection bias in favor of patients with positively experiences of alemtuzumab, as patient participation in the extension study was voluntary. 47 Nevertheless, the study confirmed the efficacy and safety of alemtuzumab on long-term follow-up.…”

COVID-19 and the Use of Immunomodulatory Agents in Ophthalmology

“…The highest risk of serious infectious complications with alemtuzumab use in patients with multiple sclerosis was reported to be the first year of treatment (3.3%/year). 87 In the same study, it was observed that the incidence of serious infections decreased in the long term (0.8%/year) in patients with 12-year follow-up. An analysis of 399 patients receiving different treatments for multiple sclerosis (including alemtuzumab) indicated that COVID-19 incidence and disease course were similar to those in the normal population.…”

“…The 12-year long-term outcomes of alemtuzumab use in multiple sclerosis patients were recently published. 87 Its efficacy has been demonstrated both clinically and on magnetic resonance imaging. There are case reports related to its use in the treatment of uveitis.…”

Alemtuzumab in a Large Real-Life Cohort: Interim Baseline Data of the TREAT-MS Study

“…Three randomized, rater-blinded clinical trials assessing the efficacy of alemtuzumab in MS treatment, using an effective comparator drug, have been performed: CAMMS223 (9), CARE-MS I (10), and CARE-MS II (11). In sum, alemtuzumab significantly reduced clinical and radiological disease activity and slowed down progression of relapsing-remitting MS (RRMS) to secondary progressive MS, also in the long-term and in patients with highly active disease (HAD) (4,(12)(13)(14)(15).…”