Dataset of a retrospective multicenter cohort study on characteristics of immune checkpoint inhibitor-induced encephalitis and comparison with HSV-1 and anti-LGI1 encephalitis.

Over the past decade, cancer immunotherapy with immune checkpoint inhibitors (ICIs) has significantly improved the outcome of many malignancies. However, with the broad use of ICIs, neurological immune related adverse events (irAE) are increasingly recognized. ICI-induced encephalitis (ICI-iE) is a particularly severe irAE, often leading to treatment termination, long-term sequalae or death. Despite its high morbidity and mortality, data on clinical features and diagnostic criteria are limited. We aimed to define clinical, radiologic and laboratory characteristics of ICI-iE and identify factors that discriminate it from anti-leucine-rich glioma-inactivated (anti-LGI)-1 encephalitis and herpes simplex virus (HSV)-1 encephalitis - two alternative causes of encephalitis - to increase the awareness of ICI-iE and improve its diagnosis and management. To that end, we retrospectively collected 30 cases of ICI-iE that were reported to the Side Effect Registry Immuno-Oncology (SERIO) and 46 cases of anti-LGI1 encephalitis or herpes simplex virus (HSV)-1 encephalitis that presented to a large German neurological referral center (Charité Universitätsmedizin Berlin) between January 2015 and September 2021. Signs and symptoms, imaging and electroencephalogram features, laboratory findings and outcome measures were assessed using standardized case report forms as well as patients' medical records and compared between the groups. The data reported here represents the largest primary cohort of patients with ICI-iE to date and the first comparison with other types of encephalitis. As all three disorders - ICI-iE, HSV-1 encephalitis and anti-LGI1 encephalitis - are rare neurological entities, this dataset can be used as a reference in future clinical studies on ICI-induced neurotoxicity, neurological autoimmune disorders, and central nervous system infections.

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Déclaration de conflit d'intérêts

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. X The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: LMJ, JMV, WB, PH, RM, AC, TH, FM, LR, PB, JAS, TE, MT, CH, LvB, THu, declare no conflicts of interest. SZ declares speaker's fees or travel grants from Bristol-Myers Squibb (BMS), Sun Pharma and Merck Sharp & Dohme (MSD). ME received funding from DFG under Germany´s Excellence Strategy – EXC-2049 – 390688087, BMBF, DZNE, DZHK, EU, Corona Foundation, and Fondation Leducq. ME reports grants from Bayer and fees paid to the Charité from AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo, Amgen, GSK, Sanofi, Covidien, Novartis, Pfizer, all outside the submitted work. CUB received compensation (all paid to the institute except TRV) for advisory roles for BMS, MSD, Roche, Novartis, GlaxoSmithKline, AstraZeneca, Pfizer, Lilly, GenMab, Pierre Fabre, Third Rock Ventures, received research funding (all paid to the institute) from BMS, Novartis, NanoString, and declares stockownership in Immagene BV, where he is co-founder. AG received speaker´s honoraria from Allmiral, BMS, MSD and Roche; AG has intermittent advisory board relationships with Amgen, BMS, Novartis, MSD, Pierre Fabre Pharmaceuticals, Pfizer, Roche and Sanofi Genzyme; travel and congress fee support from BMS, MSD, Novartis, Pierre Fabre Pharmaceuticals and Roche. Clinical studies: Amgen, Array, BMS, GSK, Novartis, Merck, MSD, Pfizer, and Roche. MS received speaker's honoraria and travel grants from Abbvie, BMS, Merck, MSD, Novartis, Pfizer, and Sanofi. JCH has served as a consultant for GSK, MSD, Pierre Fabre, Sun Pharma (personal) and BMS, Immunocore, Nektar, Novartis, Philogen (institution); received speaker's honoraria from Almirall, Amgen, BMS, GSK, MSD, Novartis, Pfizer, Pierre Fabre, Roche, Sanofi (personal); a scientific grant from BMS and Sun Pharma (institution) and clinical trial honoraria for BioNTech, BMS, Genentech, Immunocore, Iovance, MSD, Novartis, Philogen, Pierre Fabre, Regeneron, Roche, Sanofi, 4SC (institution). SU declares research support from BMS and Merck Serono; speakers and advisory board honoraria from BMS, MSD, Merck Serono, Novartis and Roche, and travel support from BMS, MSD, and Pierre Fabre Pharmaceuticals. LZ served as consultant and/or has received honoraria from BMS, MSD, Novartis, Pierre Fabre Pharmaceuticals, Sun Pharma and Sanofi; Research funding to institution: Novartis; travel support from MSD, BMS, Amgen, Pierre-Fabre, Sun Pharma, Sanofi and Novartis, outside the submitted work. LS declares advisory and speaker honoraria from BMS. KCK has served as consultant or/and has received honoraria from Amgen, Roche, BMS, MSD, Pierre Fabre Pharmaceuticals, and Novartis, and received travel support from Amgen, BMS, MSD, Amgen, Pierre Fabre Pharmaceuticals, Medac and Novartis. RSB has served as consultant for and/or received honoraria from Amgen, AstraZeneca, BMS, Celgene, Jansen-Cilag, MSD, Merck Seono, Novartis, Pfizer, and Roche. GVL is consultant advisor for Agenus, Amgen, Array Biopharma, Boehringer Ingelheim, BMS, Evaxion, Hexal AG (Sandoz Company), Highlight Therapeutics S.L., Innovent Biologics USA, MSD, Novartis Pharma AG, OncoSec, PHMR Limited, Pierre Fabre Pharmaceuticals, Provectus, Qbiotics, Regeneron. FS has received an honorarium from Gilead for an advisory board meeting. MS received speaker's honoraria and participated in advisory boards of BMS, Novartis, MSD, Roche, Pierre Fabre Pharmaceuticals, Kyowa Kirin, Immunocore, Recordati and Sanofi-Genzyme. MS received travel accommodation and expenses by Novartis, Pierre Fabre Pharmaceuticals, and Sun Pharma. LEF has served as consultant for Galderma, Janssen, Leo Pharma, Eli Lilly, Almirall, Union Therapeutics, Regeneron, Novartis, Amgen, Abbvie, UCB, Biotest, and InflaRx. SK received compensation for advising roles for Biogen. LH has served as consultant for Amgen, BMS, Biome-dx, EMA, Immunocore, Kyowa Kirin, MSD, Novartis, Pierre Fabre Pharmaceuticals, Roche, and Sanofi.