PMID- 33837059 OWN - NLM STAT- MEDLINE DCOM- 20211215 LR - 20211215 IS - 2332-7812 (Electronic) IS - 2332-7812 (Linking) VI - 8 IP - 3 DP - 2021 May TI - Skin Reactions in Patients With Multiple Sclerosis Receiving Cladribine Treatment. LID - 10.1212/NXI.0000000000000990 [doi] LID - e990 AB - OBJECTIVE: To report 77 patients with multiple sclerosis (MS) who developed skin-related adverse events (AEs) following treatment with cladribine. METHODS: We evaluated our prospective bicentric cladribine cohort. Cladribine-treated patients with a skin AE were identified. RESULTS: Two hundred thirty-nine cladribine-treated patients with MS were evaluated. Seventy-seven patients (32%) showed at least 1 skin AE at median 1 month after cladribine initiation (range: 1-12). Within first 3 months following last cladribine exposition, hair thinning (n = 28, 12%), skin rash (n = 20; 8%), mucositis (n = 13, 5%), and pruritus (n = 6, 3%) were observed. Furthermore, 35 patients (15%) developed herpes virus infections (time since last cladribine exposition: median 83 [range: 10-305]). In 15 patients, herpes zoster infection was severe (CTCAE grade >/= 3) and required hospitalization. Delayed skin AEs (>/=3 months after a cladribine treatment cycle) involved 1 case of leukocytoclastic vasculitis and 2 cases of alopecia areata. Finally, 2 patients presented with in total 3 isolated precancerous lesions (1 leukoplakia simplex and 2 actinic keratosis) and 1 patient developed a squamous cell carcinoma. CONCLUSION: Skin AEs are common in patients with MS treated with cladribine. Until risk management plans have been adjusted to include these phenomena, clinicians should perform a thorough clinical follow-up and in suspicious cases seek early interdisciplinary support. In light of the observed delayed skin reactions, we further emphasize the necessity of careful clinical surveillance of cladribine-treated patients for yet undescribed secondary autoimmune events. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that skin-related AEs are frequent in patients with MS following cladribine in a real-world setting. CI - Copyright (c) 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology. FAU - Rolfes, Leoni AU - Rolfes L AD - From the Department of Neurology (L.R., S.P., M.P., T.R., H.W.), Institute of Translational Neurology, University Hospital of Munster, Germany; Department of Neurology (J.H., C.K., R.P.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; Department of Dermatology (W.S.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; and Department of Neurology (M.K., S.G.M.), University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Germany. leoni.rolfes@ukmuenster.de. FAU - Pfeuffer, Steffen AU - Pfeuffer S AUID- ORCID: 0000-0001-5171-4845 AD - From the Department of Neurology (L.R., S.P., M.P., T.R., H.W.), Institute of Translational Neurology, University Hospital of Munster, Germany; Department of Neurology (J.H., C.K., R.P.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; Department of Dermatology (W.S.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; and Department of Neurology (M.K., S.G.M.), University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Germany. FAU - Hackert, Jana AU - Hackert J AD - From the Department of Neurology (L.R., S.P., M.P., T.R., H.W.), Institute of Translational Neurology, University Hospital of Munster, Germany; Department of Neurology (J.H., C.K., R.P.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; Department of Dermatology (W.S.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; and Department of Neurology (M.K., S.G.M.), University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Germany. FAU - Pawlitzki, Marc AU - Pawlitzki M AD - From the Department of Neurology (L.R., S.P., M.P., T.R., H.W.), Institute of Translational Neurology, University Hospital of Munster, Germany; Department of Neurology (J.H., C.K., R.P.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; Department of Dermatology (W.S.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; and Department of Neurology (M.K., S.G.M.), University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Germany. FAU - Ruck, Tobias AU - Ruck T AD - From the Department of Neurology (L.R., S.P., M.P., T.R., H.W.), Institute of Translational Neurology, University Hospital of Munster, Germany; Department of Neurology (J.H., C.K., R.P.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; Department of Dermatology (W.S.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; and Department of Neurology (M.K., S.G.M.), University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Germany. FAU - Sondermann, Wiebke AU - Sondermann W AD - From the Department of Neurology (L.R., S.P., M.P., T.R., H.W.), Institute of Translational Neurology, University Hospital of Munster, Germany; Department of Neurology (J.H., C.K., R.P.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; Department of Dermatology (W.S.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; and Department of Neurology (M.K., S.G.M.), University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Germany. FAU - Korsen, Melanie AU - Korsen M AD - From the Department of Neurology (L.R., S.P., M.P., T.R., H.W.), Institute of Translational Neurology, University Hospital of Munster, Germany; Department of Neurology (J.H., C.K., R.P.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; Department of Dermatology (W.S.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; and Department of Neurology (M.K., S.G.M.), University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Germany. FAU - Wiendl, Heinz AU - Wiendl H AD - From the Department of Neurology (L.R., S.P., M.P., T.R., H.W.), Institute of Translational Neurology, University Hospital of Munster, Germany; Department of Neurology (J.H., C.K., R.P.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; Department of Dermatology (W.S.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; and Department of Neurology (M.K., S.G.M.), University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Germany. FAU - Meuth, Sven G AU - Meuth SG AD - From the Department of Neurology (L.R., S.P., M.P., T.R., H.W.), Institute of Translational Neurology, University Hospital of Munster, Germany; Department of Neurology (J.H., C.K., R.P.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; Department of Dermatology (W.S.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; and Department of Neurology (M.K., S.G.M.), University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Germany. FAU - Kleinschnitz, Christoph AU - Kleinschnitz C AUID- ORCID: 0000-0002-1650-8875 AD - From the Department of Neurology (L.R., S.P., M.P., T.R., H.W.), Institute of Translational Neurology, University Hospital of Munster, Germany; Department of Neurology (J.H., C.K., R.P.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; Department of Dermatology (W.S.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; and Department of Neurology (M.K., S.G.M.), University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Germany. FAU - Pul, Refik AU - Pul R AD - From the Department of Neurology (L.R., S.P., M.P., T.R., H.W.), Institute of Translational Neurology, University Hospital of Munster, Germany; Department of Neurology (J.H., C.K., R.P.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; Department of Dermatology (W.S.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; and Department of Neurology (M.K., S.G.M.), University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Germany. LA - eng PT - Journal Article DEP - 20210409 PL - United States TA - Neurol Neuroimmunol Neuroinflamm JT - Neurology(R) neuroimmunology & neuroinflammation JID - 101636388 RN - 47M74X9YT5 (Cladribine) SB - IM MH - Adult MH - Aged MH - Cladribine/*adverse effects MH - Cohort Studies MH - Female MH - Humans MH - Male MH - Middle Aged MH - Multiple Sclerosis/*complications/*drug therapy MH - Prospective Studies MH - Skin MH - Skin Diseases/*chemically induced PMC - PMC8042777 EDAT- 2021/04/11 06:00 MHDA- 2021/12/16 06:00 PMCR- 2021/04/09 CRDT- 2021/04/10 05:38 PHST- 2020/12/07 00:00 [received] PHST- 2021/02/16 00:00 [accepted] PHST- 2021/04/10 05:38 [entrez] PHST- 2021/04/11 06:00 [pubmed] PHST- 2021/12/16 06:00 [medline] PHST- 2021/04/09 00:00 [pmc-release] AID - 8/3/e990 [pii] AID - NEURIMMINFL2020038323 [pii] AID - 10.1212/NXI.0000000000000990 [doi] PST - epublish SO - Neurol Neuroimmunol Neuroinflamm. 2021 Apr 9;8(3):e990. doi: 10.1212/NXI.0000000000000990. Print 2021 May.