Published in the New England Journal of Medicine (2008), the CAMMS223 trial provides critical insights into the efficacy of Alemtuzumab compared to Interferon Beta-1a in patients with early, relapsing-remitting multiple sclerosis (RRMS). This phase 2, randomized, blinded study highlights the potential of aggressive anti-inflammatory treatment early in the disease course.
Objective
The trial hypothesized that early aggressive treatment targeting inflammation in the brain could protect patients with MS from accumulating long-term disability.
Key Details
- Study Design: Phase 2, randomized, blinded trial
- Participants: 334 patients with relapsing-remitting multiple sclerosis (RRMS)
- Intervention Groups:
- Control Group: Interferon Beta-1a (44 μg S/C three times per week)
- Treatment Group: Annual IV cycles of Alemtuzumab (12 mg or 24 mg/day)
Inclusion Criteria
- Age 18–50 years
- Diagnosis of MS per McDonald’s criteria (2001) with MRI confirmation
- MS onset ≤3 years
- Expanded Disability Status Scale (EDSS) score of 0.0–3.0
- At least two relapses in the prior two years
- At least one gadolinium-enhancing lesion on screening MRI
Primary Outcomes
- Rate of Sustained Accumulation of Disability
- Alemtuzumab: 9.0%
- Interferon Beta-1a: 26.2%
Hazard Ratio (HR): 0.29 (95% CI: 0.16–0.54, P < 0.001)
- Annualized Rate of Relapse
- Alemtuzumab: 0.10
- Interferon Beta-1a: 0.36
HR: 0.26 (95% CI: 0.16–0.41, P < 0.001)
Secondary Outcome
Mean Disability Score on a 10-Point Scale
- Improved in the Alemtuzumab group but worsened in the Interferon Beta-1a group.
Mean Change: 0.38 points in favor of Alemtuzumab (P < 0.001)
Conclusion
The CAMMS223 trial demonstrated that Alemtuzumab significantly reduced both disability progression and relapse rates in patients with early RRMS compared to Interferon Beta-1a. However, treatment with Alemtuzumab was associated with a higher risk of autoimmune complications, particularly immune thrombocytopenic purpura.
Clinical Implications
Alemtuzumab represents a highly effective treatment option for early RRMS but requires careful monitoring for autoimmune side effects. Its use may be reserved for patients with aggressive disease who do not respond adequately to other first-line therapies.
Reference:
The CAMMS223 Trial Investigators et al. “Alemtuzumab vs. Interferon Beta-1a in Early Multiple Sclerosis.” N Engl J Med. 2008;359:1786–1801.
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