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Alemtuzumab improves contrast sensitivity in patients with relapsing-remitting multiple sclerosis.
Mult Scler. 2013 Sep; 19(10):1302-9.MS

Abstract

BACKGROUND

Alemtuzumab is a monoclonal antibody directed against CD52 that depletes T and B lymphocytes.

OBJECTIVE

To evaluate the treatment effect of alemtuzumab on low-contrast vision in relapsing-remitting multiple sclerosis (RRMS) patients.

METHODS

This was a pre-defined exploratory analysis within a randomized, rater-blinded trial (CAMMS223) that was run at 49 academic medical centers in the US and in Europe. Patients with untreated, early, RRMS (McDonald, n = 334) were randomized 1:1:1 to subcutaneous interferon beta-1a (IFNB-1a), or alemtuzumab 12 mg or 24 mg. Visual contrast sensitivity was measured for each eye at baseline and quarterly, with Pelli-Robson charts.

RESULTS

The eyes of patients in the pooled alemtuzumab group (versus IFNB-1a) had a greater than 2-fold higher rate of both 3-month and 6-month sustained visual improvement, of at least 0.3 log units (2 triplets, 6 letters) (At 3 months the hazard ratio (HR) = 2.26; CI = 1.19 to 4.31; P = 0.013; and at 6 months the HR = 2.44; CI =1.16 to 5.15; P = 0.019), and they had a lower risk of 3- and 6-month sustained worsening of at least 0.15 log units (1 triplet, 3 letters) (At 3 months the HR = 0.58; CI = 0.38 to 0.89; P = 0.012; and at 6 months HR = 0.55; CI=0.35 to 0.87; P = 0.010). Over the 36-month study period, the eyes of patients in the pooled alemtuzumab group improved in mean contrast sensitivity to a greater extent than those in the IFNB-1a group (0.080 log units versus 0.038 log units; P = 0.0102).

CONCLUSIONS

Alemtuzumab was associated with a greater chance of improved contrast sensitivity in patients with RRMS and may delay the worsening of visual function. Contrast sensitivity testing was sensitive to treatment effects, even within an active comparator study design. These results support the validity of low-contrast vision testing as a clinical outcome in MS trials.

Authors+Show Affiliations

University of Pennsylvania, Philadelphia, PA, USA. jennifer.graves@ucsf.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23459567

Citation

Graves, Jennifer, et al. "Alemtuzumab Improves Contrast Sensitivity in Patients With Relapsing-remitting Multiple Sclerosis." Multiple Sclerosis (Houndmills, Basingstoke, England), vol. 19, no. 10, 2013, pp. 1302-9.
Graves J, Galetta SL, Palmer J, et al. Alemtuzumab improves contrast sensitivity in patients with relapsing-remitting multiple sclerosis. Mult Scler. 2013;19(10):1302-9.
Graves, J., Galetta, S. L., Palmer, J., Margolin, D. H., Rizzo, M., Bilbruck, J., & Balcer, L. J. (2013). Alemtuzumab improves contrast sensitivity in patients with relapsing-remitting multiple sclerosis. Multiple Sclerosis (Houndmills, Basingstoke, England), 19(10), 1302-9. https://doi.org/10.1177/1352458513475722
Graves J, et al. Alemtuzumab Improves Contrast Sensitivity in Patients With Relapsing-remitting Multiple Sclerosis. Mult Scler. 2013;19(10):1302-9. PubMed PMID: 23459567.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Alemtuzumab improves contrast sensitivity in patients with relapsing-remitting multiple sclerosis. AU - Graves,Jennifer, AU - Galetta,Steven L, AU - Palmer,Jeffrey, AU - Margolin,David H, AU - Rizzo,Marco, AU - Bilbruck,John, AU - Balcer,Laura J, Y1 - 2013/03/04/ PY - 2013/3/6/entrez PY - 2013/3/6/pubmed PY - 2014/3/22/medline KW - Multiple sclerosis KW - alemtuzumab KW - contrast sensitivity KW - disease modifying therapy KW - interferon beta KW - outcome measurements KW - relapsing–remitting multiple sclerosis KW - visual function SP - 1302 EP - 9 JF - Multiple sclerosis (Houndmills, Basingstoke, England) JO - Mult Scler VL - 19 IS - 10 N2 - BACKGROUND: Alemtuzumab is a monoclonal antibody directed against CD52 that depletes T and B lymphocytes. OBJECTIVE: To evaluate the treatment effect of alemtuzumab on low-contrast vision in relapsing-remitting multiple sclerosis (RRMS) patients. METHODS: This was a pre-defined exploratory analysis within a randomized, rater-blinded trial (CAMMS223) that was run at 49 academic medical centers in the US and in Europe. Patients with untreated, early, RRMS (McDonald, n = 334) were randomized 1:1:1 to subcutaneous interferon beta-1a (IFNB-1a), or alemtuzumab 12 mg or 24 mg. Visual contrast sensitivity was measured for each eye at baseline and quarterly, with Pelli-Robson charts. RESULTS: The eyes of patients in the pooled alemtuzumab group (versus IFNB-1a) had a greater than 2-fold higher rate of both 3-month and 6-month sustained visual improvement, of at least 0.3 log units (2 triplets, 6 letters) (At 3 months the hazard ratio (HR) = 2.26; CI = 1.19 to 4.31; P = 0.013; and at 6 months the HR = 2.44; CI =1.16 to 5.15; P = 0.019), and they had a lower risk of 3- and 6-month sustained worsening of at least 0.15 log units (1 triplet, 3 letters) (At 3 months the HR = 0.58; CI = 0.38 to 0.89; P = 0.012; and at 6 months HR = 0.55; CI=0.35 to 0.87; P = 0.010). Over the 36-month study period, the eyes of patients in the pooled alemtuzumab group improved in mean contrast sensitivity to a greater extent than those in the IFNB-1a group (0.080 log units versus 0.038 log units; P = 0.0102). CONCLUSIONS: Alemtuzumab was associated with a greater chance of improved contrast sensitivity in patients with RRMS and may delay the worsening of visual function. Contrast sensitivity testing was sensitive to treatment effects, even within an active comparator study design. These results support the validity of low-contrast vision testing as a clinical outcome in MS trials. SN - 1477-0970 UR - https://www.unboundmedicine.com/medline/citation/23459567/Alemtuzumab_improves_contrast_sensitivity_in_patients_with_relapsing_remitting_multiple_sclerosis_ L2 - https://journals.sagepub.com/doi/10.1177/1352458513475722?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -