Contributions
Abstract: P1257
Type: Poster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Background: Teriflunomide is a new oral treatment for Relapsing Remitting Multiple Sclerosis, showing a similar efficacy to subcutaneous Interferon β-1a (IFNB1a) 3-times weekly in the phase three clinical trial “TENERE”.
Case report: A 55 years old woman with MS, started teriflunomide in May 2015, shifting from IFNB1a. After an initial period of good tolerability, in August 2015 she began to complain of hair loss (a known side effect of teriflunomide) scarcely noticeable at examination. Two months later she complained about progressive loss of hand nails occurring in the last few weeks. At examination two nails in her right hand had dropped off (one of these presenting in a regrowth phase), whereas two in the left hand presented lack of growth with consequent void at the nail matrix. Some of the remaining nails showed thinning and progressive detachment from their bed. The patient also reported persistent hair loss and denied use of new drugs or different soap or other cosmetic products. At referral an expert dermatologist excluded nail mycosis, psoriasis and other possible causes of nail dystrophy, and confirmed that the hypothesis of a causal relationship with teriflunomide was highly probable. Hence, the drug was discontinued and the patient underwent the accelerated removal procedure with oral colestiramine. A few weeks later she started therapy with dimethyl-fumarate, that was well tolerated. In the following months her nails showed progressive regrowth and normalization.
Discussion: We could not find any published reports of nail loss associated with teriflunomide treatment. We believe this represents a new adverse event of teriflunomide treatment based on the following: time relationship between event onset and starting treatment, a progressive development consistent with nail matrix growth; absence of any other change in the patient"s life such as new drugs, new diet, new cosmetics; simultaneous presence of hair loss, which presumably shares the same pathophysiological mechanism; exclusion of other possible etiologies by the dermatologist and, finally, reversibility at drug discontinuation.
Conclusion: MS specialists should be aware of this potential adverse event, which might represent a new cause of teriflunomide discontinuation.
Disclosure: Luca Mancinelli is involved in clinical trials of Merck Serono S.A. - Geneva, Biogen-Dompè, Bayer Schering, Novartis and Teva.
Maria di Ioia has received researcher and travel grant from: Merck Serono S.A. - Geneva, Biogen-Dompè, Novartis, Genzyme and Bayer and is involved in clinical trials of the same companies, plus Teva.
Valeria Di Tommaso has received travel grant from: Merck Serono S.A. - Geneva, Biogen-Dompè, Novartis, Genzyme and Bayer and is involved in clinical trials of the same companies, plus Teva.
Erika Pietrolongo is involved in clinical trials of Merck Serono S.A. - Geneva, Biogen-Dompè, GlaxoSmithKline, Bayer Schering, Novartis and Teva.
Deborah Farina has received researcher grant from: Merck Serono S.A. - Geneva, Biogen-Dompè and is involved in clinical trials of the same companies, plus GlaxoSmithKline, Bayer Schering, Novartis and Teva.
Daniela Travaglini has received researcher grant from Novartis and is involved in clinical trials of the same companies, plus GlaxoSmithKline, Merck Serono, Bayer and Teva.
Giovanna De Luca has received researcher grant from: Merck Serono S.A. - Geneva, Biogen-Dompè and is involved in clinical trials of the same companies, plus GlaxoSmithKline, Bayer Schering, Novartis and Teva.
Paolo Amerio: nothing to disclose.
Alessandra Lugaresi is a Bayer, Biogen, Genzyme, Merck Advisory Board Member. She received travel grants and honoraria from Bayer, Biogen, Merck, Novartis, Sanofi, Teva. Her institution received research grants from Bayer, Biogen, Merck, Novartis, Sanofi, Teva.
Abstract: P1257
Type: Poster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Background: Teriflunomide is a new oral treatment for Relapsing Remitting Multiple Sclerosis, showing a similar efficacy to subcutaneous Interferon β-1a (IFNB1a) 3-times weekly in the phase three clinical trial “TENERE”.
Case report: A 55 years old woman with MS, started teriflunomide in May 2015, shifting from IFNB1a. After an initial period of good tolerability, in August 2015 she began to complain of hair loss (a known side effect of teriflunomide) scarcely noticeable at examination. Two months later she complained about progressive loss of hand nails occurring in the last few weeks. At examination two nails in her right hand had dropped off (one of these presenting in a regrowth phase), whereas two in the left hand presented lack of growth with consequent void at the nail matrix. Some of the remaining nails showed thinning and progressive detachment from their bed. The patient also reported persistent hair loss and denied use of new drugs or different soap or other cosmetic products. At referral an expert dermatologist excluded nail mycosis, psoriasis and other possible causes of nail dystrophy, and confirmed that the hypothesis of a causal relationship with teriflunomide was highly probable. Hence, the drug was discontinued and the patient underwent the accelerated removal procedure with oral colestiramine. A few weeks later she started therapy with dimethyl-fumarate, that was well tolerated. In the following months her nails showed progressive regrowth and normalization.
Discussion: We could not find any published reports of nail loss associated with teriflunomide treatment. We believe this represents a new adverse event of teriflunomide treatment based on the following: time relationship between event onset and starting treatment, a progressive development consistent with nail matrix growth; absence of any other change in the patient"s life such as new drugs, new diet, new cosmetics; simultaneous presence of hair loss, which presumably shares the same pathophysiological mechanism; exclusion of other possible etiologies by the dermatologist and, finally, reversibility at drug discontinuation.
Conclusion: MS specialists should be aware of this potential adverse event, which might represent a new cause of teriflunomide discontinuation.
Disclosure: Luca Mancinelli is involved in clinical trials of Merck Serono S.A. - Geneva, Biogen-Dompè, Bayer Schering, Novartis and Teva.
Maria di Ioia has received researcher and travel grant from: Merck Serono S.A. - Geneva, Biogen-Dompè, Novartis, Genzyme and Bayer and is involved in clinical trials of the same companies, plus Teva.
Valeria Di Tommaso has received travel grant from: Merck Serono S.A. - Geneva, Biogen-Dompè, Novartis, Genzyme and Bayer and is involved in clinical trials of the same companies, plus Teva.
Erika Pietrolongo is involved in clinical trials of Merck Serono S.A. - Geneva, Biogen-Dompè, GlaxoSmithKline, Bayer Schering, Novartis and Teva.
Deborah Farina has received researcher grant from: Merck Serono S.A. - Geneva, Biogen-Dompè and is involved in clinical trials of the same companies, plus GlaxoSmithKline, Bayer Schering, Novartis and Teva.
Daniela Travaglini has received researcher grant from Novartis and is involved in clinical trials of the same companies, plus GlaxoSmithKline, Merck Serono, Bayer and Teva.
Giovanna De Luca has received researcher grant from: Merck Serono S.A. - Geneva, Biogen-Dompè and is involved in clinical trials of the same companies, plus GlaxoSmithKline, Bayer Schering, Novartis and Teva.
Paolo Amerio: nothing to disclose.
Alessandra Lugaresi is a Bayer, Biogen, Genzyme, Merck Advisory Board Member. She received travel grants and honoraria from Bayer, Biogen, Merck, Novartis, Sanofi, Teva. Her institution received research grants from Bayer, Biogen, Merck, Novartis, Sanofi, Teva.