Skip to main content
Top
Published in: Neurology and Therapy 2/2018

Open Access 01-12-2018 | Original Research

Real-World Observational Evaluation of Hair Thinning in Patients with Multiple Sclerosis Receiving Teriflunomide: Is It an Issue in Clinical Practice?

Authors: Lori Hendin Travis, Annette Okai, Steve Cavalier, Darren Stam, Lisa Farnett, Keith R. Edwards

Published in: Neurology and Therapy | Issue 2/2018

Login to get access

Abstract

Introduction

Hair thinning occurred in 10–14% of teriflunomide-treated patients in the teriflunomide multiple sclerosis clinical development program, compared with 5% of placebo-treated patients. Our objective was to examine the clinical course of hair thinning in patients in an observational real-world project.

Methods

Patients with relapsing–remitting multiple sclerosis who reported hair thinning to healthcare professionals (HCPs) during treatment with teriflunomide were eligible for inclusion. During two office visits, one at onset of hair thinning and another at follow-up, HCPs and patients completed questionnaires that categorized hair thinning as mild, moderate, or severe, or from 0 (no hair thinning) to 10 (very severe hair thinning), respectively. At the follow-up visit, patients also rated the degree of recovery. Patients were photographed at both visits with a standardized protocol and camera.

Results

Of the 38 patients who completed follow-up, most were women (97%) without prior history of hair thinning (87%), with the majority (68%) receiving concomitant medications potentially associated with hair thinning. The mean time to onset of hair thinning was 77 days after the first teriflunomide dose. HCPs classified the majority of hair thinning events as mild (63%) or moderate (34%), with one event classified as severe (3%). The mean patient severity perception was 5/10, and complete/near-complete resolution or marked improvement was reported by 79% of patients.

Conclusion

Consistent with observations from the teriflunomide clinical program, hair thinning was usually mild and occurred within the first 3 months of treatment, with most patients fully recovering while remaining on teriflunomide treatment. As with any potential adverse event, it is important to ensure appropriate expectations through patient education before treatment.

Funding

Sanofi.
Literature
3.
go back to reference Harrison S, Bergfeld W. Diffuse hair loss: its triggers and management. Cleve Clin J Med. 2009;76:361–7.CrossRefPubMed Harrison S, Bergfeld W. Diffuse hair loss: its triggers and management. Cleve Clin J Med. 2009;76:361–7.CrossRefPubMed
4.
go back to reference Walther EU, Hohlfeld R. Multiple sclerosis: side effects of interferon beta therapy and their management. Neurology. 1999;53:1622–7.CrossRefPubMed Walther EU, Hohlfeld R. Multiple sclerosis: side effects of interferon beta therapy and their management. Neurology. 1999;53:1622–7.CrossRefPubMed
5.
go back to reference Losavio FA, Lucchini M, De Fino C, Mirabella M, Nociti V. Transient hair loss during treatment with dimethyl-fumarate for multiple sclerosis. Mult Scler Relat Disord. 2016;7:68–9.CrossRefPubMed Losavio FA, Lucchini M, De Fino C, Mirabella M, Nociti V. Transient hair loss during treatment with dimethyl-fumarate for multiple sclerosis. Mult Scler Relat Disord. 2016;7:68–9.CrossRefPubMed
6.
7.
go back to reference Pacheco MF, Jacobe H, Eagar TN, Stuve O. Reversible alopecia associated with glatiramer acetate. Arch Neurol. 2010;67:1154.CrossRefPubMed Pacheco MF, Jacobe H, Eagar TN, Stuve O. Reversible alopecia associated with glatiramer acetate. Arch Neurol. 2010;67:1154.CrossRefPubMed
8.
go back to reference Zimmermann JS, Buhl T, Müller M. Alopecia universalis following alemtuzumab treatment in multiple sclerosis: a barely recognized manifestation of secondary autoimmunity-report of a case and review of the literature. Front Neurol. 2017;8:569.CrossRefPubMedCentralPubMed Zimmermann JS, Buhl T, Müller M. Alopecia universalis following alemtuzumab treatment in multiple sclerosis: a barely recognized manifestation of secondary autoimmunity-report of a case and review of the literature. Front Neurol. 2017;8:569.CrossRefPubMedCentralPubMed
9.
go back to reference Comi G, Freedman MS, Kappos L, et al. Pooled safety and tolerability data from four placebo-controlled teriflunomide studies and extensions. Mult Scler Relat Disord. 2016;5:97–104.CrossRefPubMed Comi G, Freedman MS, Kappos L, et al. Pooled safety and tolerability data from four placebo-controlled teriflunomide studies and extensions. Mult Scler Relat Disord. 2016;5:97–104.CrossRefPubMed
11.
go back to reference O’Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011;365:1293–303.CrossRefPubMed O’Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011;365:1293–303.CrossRefPubMed
12.
go back to reference Freedman MS, Miller AE, Comi G, et al. Outcomes of the TEMSO extension study of teriflunomide: 10.5 years of clinical results. Mult Scler. 2016;22(S3):807. Freedman MS, Miller AE, Comi G, et al. Outcomes of the TEMSO extension study of teriflunomide: 10.5 years of clinical results. Mult Scler. 2016;22(S3):807.
13.
go back to reference Coyle PK, Khatri B, Edwards KR, et al. Teriflunomide real-world safety profile: results of the phase 4 Teri-PRO study. Mult Scler. 2016;22(S3):774. Coyle PK, Khatri B, Edwards KR, et al. Teriflunomide real-world safety profile: results of the phase 4 Teri-PRO study. Mult Scler. 2016;22(S3):774.
14.
go back to reference Avonex (interferon-beta-1a). Prescribing information. Cambridge, MA: Biogen; 2016. Avonex (interferon-beta-1a). Prescribing information. Cambridge, MA: Biogen; 2016.
15.
go back to reference Betaseron (interferon beta-1b). Prescribing Information. Whippany, NJ: Bayer HealthCare Pharmaceuticals; 2016. Betaseron (interferon beta-1b). Prescribing Information. Whippany, NJ: Bayer HealthCare Pharmaceuticals; 2016.
Metadata
Title
Real-World Observational Evaluation of Hair Thinning in Patients with Multiple Sclerosis Receiving Teriflunomide: Is It an Issue in Clinical Practice?
Authors
Lori Hendin Travis
Annette Okai
Steve Cavalier
Darren Stam
Lisa Farnett
Keith R. Edwards
Publication date
01-12-2018
Publisher
Springer Healthcare
Published in
Neurology and Therapy / Issue 2/2018
Print ISSN: 2193-8253
Electronic ISSN: 2193-6536
DOI
https://doi.org/10.1007/s40120-018-0107-y

Other articles of this Issue 2/2018

Neurology and Therapy 2/2018 Go to the issue