Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis: The MIRROR study
Neurology. 2018 May 15;90(20):e1805-e1814.
Objective: To assess dose-response effects of the anti-CD20 monoclonal antibody ofatumumab on efficacy and safety outcomes in a phase 2b double-blind study of relapsing forms of multiple sclerosis (RMS).
Methods: Patients (n = 232) were randomized to ofatumumab 3, 30, or 60 mg every 12 weeks, ofatumumab 60 mg every 4 weeks, or placebo for a 24-week treatment period, with a primary endpoint of cumulative number of new gadolinium-enhancing lesions (per brain MRI) at week 12. Relapses and safety/tolerability were assessed, and CD19+ peripheral blood B-lymphocyte counts measured. Safety monitoring continued weeks 24 to 48 with subsequent individualized follow-up evaluating B-cell repletion.
Results: The cumulative number of new lesions was reduced by 65% for all ofatumumab dose groups vs placebo (p < 0.001). Post hoc analysis (excluding weeks 1-4) estimated a ≥90% lesion reduction vs placebo (week 12) for all cumulative ofatumumab doses ≥30 mg/12 wk. Dose-dependent CD19 B-cell depletion was observed. Notably, complete depletion was not necessary for a robust treatment effect. The most common adverse event was injection-related reactions (52% ofatumumab, 15% placebo), mild to moderate severity in 97%, most commonly associated with the first dose and diminishing on subsequent dosing.
Conclusion: Imaging showed that all subcutaneous ofatumumab doses demonstrated efficacy (most robust: cumulative doses ≥30 mg/12 wk), with a safety profile consistent with existing ofatumumab data. This treatment effect also occurred with dosage regimens that only partially depleted circulating B cells.
Classification of evidence: This study provides Class I evidence that for patients with RMS, ofatumumab decreases the number of new MRI gadolinium-enhancing lesions 12 weeks after treatment initiation.
Trial registration: ClinicalTrials.gov NCT01457924.
Free full text.
Ofatumumab Phase IIb Trial, MIRROR Study
Kesimpta is a subcutaneously injected anti CD20 monoclonal antibody approved for RRMS and active progressive MS.
Return to “Kesimpta (Ofatumumab)”
Jump to
- Multiple Sclerosis
- ↳ General Discussion
- ↳ Introductions
- ↳ Drug Pipeline
- ↳ Regimens
- ↳ Undiagnosed
- ↳ MS Etiology and Pathogenesis
- Treatments
- ↳ Chronic Cerebrospinal Venous Insufficiency (CCSVI)
- ↳ Low Dose Naltrexone
- ↳ Tysabri (Antegren, Natalizumab)
- ↳ Copaxone
- ↳ Glatopa
- ↳ Avonex
- ↳ Rebif
- ↳ Betaseron
- ↳ Plegridy
- ↳ Novantrone
- ↳ Aimspro
- ↳ Diet
- ↳ Stem Cells
- ↳ Antibiotics
- ↳ Campath (Lemtrada, Alemtuzumab)
- ↳ Gene Therapy
- ↳ Natural Approach
- ↳ Biotin (Qizenday, Cerenday, MD1003)
- ↳ Coimbra High-Dose Vitamin D Protocol
- ↳ Statins
- ↳ Tcelna (Tovaxin)
- ↳ Revimmune (Cyclophosphamide, Cytoxan)
- ↳ Medical Devices
- ↳ Rituxan (Rituximab)
- ↳ Ocrevus (Ocrelizumab)
- ↳ Kesimpta (Ofatumumab)
- ↳ Briumvi (Ublituximab-xiiy)
- ↳ General Medications
- ↳ Tecfidera (BG-12, Dimethyl fumarate)
- ↳ Vumerity (Diroximel fumarate)
- ↳ Bafiertam (Monomethyl fumarate)
- ↳ Gilenya
- ↳ Aubagio (Teriflunomide)
- ↳ Mayzent (Siponimod)
- ↳ Zeposia (Ozanimod)
- ↳ Ponvory (Ponesimod)
- ↳ Mavenclad (Cladribine)
- ↳ Ampyra (Dalfampridine)
- ↳ Medical Marijuana
- ↳ Sativex
- ↳ Chiropractic Treatment
- Life
- ↳ Daily Life
- ↳ Veterans and MS
- ↳ Trigeminal Neuralgia in MS
- ↳ Reading Nook
- ↳ Humor
- ↳ Shopping
- ↳ Friends and Family
- ↳ Mental & Spiritual Health
- ↳ Exercise and Physical Therapy
- ↳ Under 25 with MS
- ↳ MS in the Golden Years
- ↳ Parenting Kids With MS
- ↳ Parents with MS
- ThisIsMS.com
- ↳ Site Support
- ↳ Suggestions