PMID- 32960413 OWN - NLM STAT- MEDLINE DCOM- 20210216 LR - 20211020 IS - 1179-6901 (Electronic) IS - 1174-5886 (Print) IS - 1174-5886 (Linking) VI - 20 IP - 4 DP - 2020 Dec TI - Systematic Review: Monoclonal Antibody-Induced Subacute Cutaneous Lupus Erythematosus. PG - 319-330 LID - 10.1007/s40268-020-00320-5 [doi] AB - BACKGROUND: Subacute cutaneous lupus erythematosus (SCLE) lacks consensus diagnostic criteria and the pathogenesis is poorly understood. There are increasing reports of SCLE induced by monoclonal antibodies (mAbs), but there are limited data on the aetiology, clinical characteristics and natural course of this disease. METHODS: We devised a set of diagnostic criteria for SCLE in collaboration with a multinational, multispecialty panel. This systematic review employed a two-layered search strategy of five databases for cases of mAb-induced SCLE (PROSPERO registered protocol CRD42019116521). To explore the relationship between relative mAb use and the number of SCLE cases reported, the estimated number of mAb users was modelled from 2013 to 2018 global commercial data and estimated annual therapy costs. RESULTS: From 40 papers, we identified 52 cases of mAb-induced SCLE, occurring in a cohort that was 73% female and with a median age of 61 years. Fifty percent of cases were induced by anti-tumour necrosis factor (TNF)-a agents. A median of three drug doses preceded SCLE onset and the lesions lasted a median of 7 weeks after drug cessation. Oral and topical corticosteroids were most frequently used. Of the licensed mAbs, adalimumab, denosumab, rituximab, etanercept and infliximab were calculated to have the highest relative number of yearly users based on global sales data. Comparing the number of mAb-induced SCLE cases with estimated yearly users, the checkpoint inhibitors pembrolizumab and nivolumab showed strikingly high rates of SCLE relative to their global use, but ipilimumab did not. CONCLUSION: We present the first systematic review characterising mAb-induced SCLE with respect to triggers, clinical signs, laboratory findings, prognosis and treatment approaches. We identify elevated rates associated with the use of checkpoint inhibitors and anti-TNFa agents. FAU - Bolton, Chrissy AU - Bolton C AUID- ORCID: 0000-0003-0240-3244 AD - University College London, University College London Hospitals NHS Foundation Trust, London, UK. Christine.bolton@nhs.net. AD - Medical Sciences Division, University of Oxford, Oxford, UK. Christine.bolton@nhs.net. AD - Translational Gastroenterology Unit, Experimental Medicine, University of Oxford, John Radcliffe Hospital, Oxford, OX3 9DU, UK. Christine.bolton@nhs.net. FAU - Chen, Yifan AU - Chen Y AD - Medical Sciences Division, University of Oxford, Oxford, UK. FAU - Hawthorne, Rachel AU - Hawthorne R AD - John Radcliffe Hospital, Oxford University Hospitals NHS Trust, Oxford, UK. FAU - Schepel, Ianthe R M AU - Schepel IRM AD - Medical Sciences Division, University of Oxford, Oxford, UK. FAU - Harriss, Elinor AU - Harriss E AD - Bodleian Health Care Libraries, The Knowledge Centre, Oxford University Old Road Campus Research Building, Oxford, UK. FAU - Hofmann, Silke C AU - Hofmann SC AD - Department of Dermatology, Allergology and Dermatosurgery, HELIOS University Hospital Wuppertal, University of Witten/Herdecke, Wuppertal, Germany. FAU - Ellis, Spencer AU - Ellis S AD - Lister Hospital, East and North Herts NHS Trust, Stevenage, UK. FAU - Clarke, Alexander AU - Clarke A AD - The Kennedy Institute of Rheumatology, University of Oxford, Oxford, UK. FAU - Wace, Helena AU - Wace H AD - Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK. FAU - Martin, Blanca AU - Martin B AD - Department of Dermatopathology, St John's Institute of Dermatology, St Thomas' Hospital, London, UK. FAU - Smith, Joel AU - Smith J AD - Nuffield Department of Population Health, University of Oxford, Oxford, UK. LA - eng PT - Journal Article PT - Systematic Review PL - New Zealand TA - Drugs R D JT - Drugs in R&D JID - 100883647 RN - 0 (Antibodies, Monoclonal) RN - 0 (Immunologic Factors) SB - IM MH - Antibodies, Monoclonal/*adverse effects/economics/therapeutic use MH - Humans MH - Immunologic Factors/*adverse effects/economics/therapeutic use MH - International Cooperation MH - Lupus Erythematosus, Cutaneous/*chemically induced/epidemiology/*therapy MH - Prognosis MH - Treatment Outcome PMC - PMC7691410 COIS- Christine Bolton, Yifan Chen, Ianthe R.M Schepel, Elinor Harriss, Silke C. Hofmann, Spencer Ellis, Alexander Clarke, Rachel Hawthorne, Helena Wace, Blanca Martin, Joel Smith declare there are no conflicts of interest. EDAT- 2020/09/23 06:00 MHDA- 2021/02/17 06:00 PMCR- 2020/09/22 CRDT- 2020/09/22 12:13 PHST- 2020/09/23 06:00 [pubmed] PHST- 2021/02/17 06:00 [medline] PHST- 2020/09/22 12:13 [entrez] PHST- 2020/09/22 00:00 [pmc-release] AID - 10.1007/s40268-020-00320-5 [pii] AID - 320 [pii] AID - 10.1007/s40268-020-00320-5 [doi] PST - ppublish SO - Drugs R D. 2020 Dec;20(4):319-330. doi: 10.1007/s40268-020-00320-5.