Teriflunomide Induced Hair Loss in Multiple Sclerosis Patients: Most But Not All Recover Density

One-Third of Patients Using Teriflunomide Have moderate to Severe Hair Loss; 20 % Do not Recover Density.

Multiple sclerosis is an immune mediated disease of the nervous system. The disease leads to damage to myelin, which is a protective layer around nerves. The result of such damage is a variety of neurological symptoms such as numbness, tingling, mood change, pain, fatigue, memory issues, blindness and weakness.

There are now about 20 or so disease modifying therapies (DMTs) available to treat MS. DMTs target some component of the inflammatory process of MS and help to either reduce the frequency and severity of relapses, reduce the number of new lesions in the brain and spinal cord as seen on MRI, and/or slow down the accumulation of disability.

There have been reports of hair thinning in patients with multiple sclerosis (MS) treated with various disease-modifying therapies (DMTs).

Teriflunomide (marketed under Aubagio) was FDA approved in 2012 for treatment of ‘relapsing forms’ of multiple sclerosis. Clinical trial data of teriflunomide showed that hair loss was observed in 10–14% of patients receiving teriflunomide compared to 5 % of patients receiving placebo. Other studies have suggested hair shedding can be an issue early on once treatment is started but then stabilizes. For example, the incidence of hair thinning with teriflunomide in one study decreased from approximately 6% of patients in the first 4 weeks of treatment, to 2.9% at 12 weeks and < 1% after 24 weeks. It’s not clear if that kind of resolution is the norm.

In 2018, Travis et al set out to examine the hair thinning that is experienced by patients using teriflunomide. The authors invited patients to complete questionnaires at their first visit and then again at follow up. Health care practitioners caring for the patients also completed a questionnaire. Patients and health care practitioners rated the hair loss on a scale from 0 to 10 - with a score of 10 being severe hair loss.

There were 38 patients in the study. 97 % of patients were women and 87 % did not have prior hair thinning problems. the mean time to onset of hair loss was 77 days (11 weeks) after the first teriflunomide dose.

Health care practitioners classified the initial hair loss in the 38 patients as being mild in 63 % of patients, moderate in 34 % and severe in 3 %. The patients rate their severity an average of 5 out of 10.

In terms of resolution of the hair loss, 37 % of patients indicated that they had complete/near-complete resolution of hair loss. 42 % had marked improvement but did not feel they had complete resolution. 18 % were rated as only ‘somewhat improved’ and 3 % had no improvement.

At the follow up visit, health care practitioners rated 18 % of patients as still having moderate thinning.

Comment

This was an interesting company sponsored paper. The authors pointed out that about 2/3 of patients were receiving concomitant medications associated with hair thinning, for conditions such as migraine, epilepsy, or depression. It’s not clear when these were all started but it’s unlikely these have a huge impact given the timing of the hair loss here.

This paper looked at only those with hair loss so we don’t have a good sense of what the density was like before the teriflunomide was started. Also, it’s not clear when follow up visits were done. If the initial appointment was conducted at week 11 and the follow up visit was done at week 16, this is not all that concerning. If the follow up visit was done at week 150, this is concerning.

The study does not allow doctors to rate hair loss at the follow up visit as “looks normal” only mild, moderate or severe. That’s clearly a problem.

There is a tendency in this paper to downplay the concerns of the patient. The authors state that “since most were informed of the possibility prior to treatment initiation, there was neither distress nor upset.” This is surprising in my experience given that even if patients are informed of hair loss, it is still quite upsetting. Patient using minoxidil for example know that they will lose hair at weeks 4-10 but still the emails pour into the office and the phone rings off the hook.

The key message in this study is that at least 18 % of patients were rated by doctors as having moderate thinning at the follow up visit. 63 % of patients felt their hair density was not back to normal. If we believe the long term data from other studies it is likely that this proportion will drop over time.

REFERENCE

Travis LH et al. Real-World Observational Evaluation of Hair Thinning in Patients with Multiple Sclerosis Receiving Teriflunomide: Is It an Issue in Clinical Practice? Neurol Ther. 2018 Dec; 7(2): 341–347.

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.