Remibrutinib: A Novel BTKi in Development for MS With a Favorable Safety Profile in Various Autoimmune Disorders (P7-3.015)

Objective: To report the safety of remibrutinib from Phase 2 clinical trials in various autoimmune disorders. Background: Remibrutinib, a potent, highly selective, covalent, oral Bruton’s tyrosine kinase inhibitor, is currently being investigated in Phase 3 trials for the treatment of multiple sclerosis (MS; NCT05147220/NCT05156281). Remibrutinib showed a favorable selectivity and potency profile in vitro, with the potential to minimize off-target toxicity and associated adverse events (AEs). Design/Methods: This safety overview reports data from a final analysis of Phase 2 trials in chronic spontaneous urticaria (CSU), Sjögren syndrome (SjS), and asthma, and interim analysis of the open-label extension (OLE) in CSU. Safety assessments comprised AEs, including serious and AEs of special interest (AESI), vital signs, ECGs, and laboratory parameters. Results: Overall, 363 patients (267, CSU; 49, SjS; 47, asthma) who received various doses (10–100 mg q.d./b.i.d.) of remibrutinib for 12–52 weeks were included. For CSU, 267 patients received different doses in the core study; in the OLE, 183 received 100 mg b.i.d. Safety of remibrutinib in the core study was comparable across dose levels. Similarly, in the OLE, safety of remibrutinib 100 mg b.i.d. was comparable to any dose in the core. For CSU, SjS, and asthma, the most frequently reported grouped AEs (≥10%) were Infections and infestations, Skin and subcutaneous, Gastrointestinal, and Nervous system disorders. Overall, AEs were comparable to placebo in core studies, with no increases in infection rates and except for skin disorders where CSU flares caused an imbalance. AESI including bleeding, infection and cytopenia remained stable with long-term treatment. No safety concerns were noted in the analysis of laboratory parameters, ECGs and vital signs. Conclusions: Remibrutinib demonstrated a favorable safety profile and was well tolerated at all doses studied in Phase 2 trials and the OLE (up to 100 mg b.i.d.), supporting its development in Phase 3 clinical trials in MS. Disclosure: Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen Idec. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis Pharmaceuticals. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genzyme. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. Dr. Williams has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Janssen. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genzyme. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Williams has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen Idec. Dr. Williams has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Meyers Squibb. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Novartis Pharmaceuticals. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genentech. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Janssen. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Williams has received publishing royalties from a publication relating to health care. Dr. Williams has a non-compensated relationship as a National Board Member with National MS Society that is relevant to AAN interests or activities. Dr. Airas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme. Dr. Airas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Airas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Airas has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Chitnis has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Chitnis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche-Genentech. Dr. Chitnis has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Academic CME. The institution of Dr. Chitnis has received research support from Novartis. The institution of Dr. Chitnis has received research support from Sanofi. The institution of Dr. Chitnis has received research support from Octave. Dr. Saini has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Saini has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Graular. Dr. Saini has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for AAAAI. Dr. Saini has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for AAAAI. Dr. Saini has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for UptoDate. The institution of Dr. Saini has received research support from Novartis. The institution of Dr. Saini has received research support from Sanofi. The institution of Dr. Saini has received research support from Regenron. Dr. Hide has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teikoku Seiyaku. Dr. Hide has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Kaken Pharmaceutical. Dr. Hide has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Kyowa-Kirin. Dr. Hide has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Mitsubishi-Tanabe. Dr. Hide has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Hide has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Hide has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Taiho. Dr. Hide has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Kyorin. The institution of Dr. Hide has received research support from Japan and Grant-in-Aid for Scientific Research. Dr. Sussman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for CSL Behring. Dr. Sussman has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Sussman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mitsubishi-Tanabe. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Chugai. Prof. Nakahara has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Prof. Nakahara has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Mitsubishi-Tanabe. Prof. Nakahara has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Takeda. Prof. Nakahara has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eisai. Prof. Nakahara has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Prof. Nakahara has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Daiichi-Sankyo. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teiijin. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Asahi Kasei. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for The Japanese Society for Internal Medicine. Prof. Nakahara has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Kagakuhyoronsha. The institution of Prof. Nakahara has received research support from Biogen. The institution of Prof. Nakahara has received research support from Keio University. The institution of Prof. Nakahara has received research support from Otsuka. The institution of Prof. Nakahara has received research support from Kyowa-Kirin. The institution of Prof. Nakahara has received research support from Chugai. The institution of Prof. Nakahara has received research support from Shionogi. The institution of Prof. Nakahara has received research support from Sumitomo-Dainippon. The institution of Prof. Nakahara has received research support from Eisai. The institution of Prof. Nakahara has received research support from Abbvie. The institution of Prof. Nakahara has received research support from JB. The institution of Prof. Nakahara has received research support from Behringer-Ingelheim. The institution of Prof. Nakahara has received research support from MSD. The institution of Prof. Nakahara has received research support from Tsumura. The institution of Prof. Nakahara has received research support from EA Pharma. The institution of Prof. Nakahara has received research support from Daiichi-Sankyo. Dr. Bermel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi/Genzyme. Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech/Roche. Dr. Bermel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Viela Bio. Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck Serono. Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Astra Zeneca. Dr. Bermel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LabCorp. Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. The institution of Dr. Bermel has received research support from Biogen. The institution of Dr. Bermel has received research support from Roche. The institution of Dr. Bermel has received research support from Novartis. Dr. Bermel has received intellectual property interests from a discovery or technology relating to health care. Prof. Doerner has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Mr. Loop has received personal compensation for serving as an employee of Amgen. Mr. Loop has received personal compensation for serving as an employee of Novartis. Mr. Loop has stock in Vertex Pharmaceuticals . Mr. Loop has stock in Novartis. Dr. Ziehn has received personal compensation for serving as an employee of Novartis AG. Dr. Willi has received personal compensation for serving as an employee of Novartis Pharma. Dr. Willi has received stock or an ownership interest from Novartis. Bernd C. Kieseier, MD has nothing to disclose. Dr. Nikolaev has received personal compensation for serving as an employee of Novartis Pharma AG. Dr. Nikolaev has stock in Novartis Pharma AG. Dr. Haemmerle has received personal compensation for serving as an employee of Novartis Pharma AG. Dr. Haemmerle has stock in Novartis Pharma AG. Dr. Zharkov has received personal compensation for serving as an employee of Novartis. Dr. Zharkov has received personal compensation for serving as an employee of Roche. An immediate family member of Dr. Zharkov has received personal compensation for serving as an employee of SOBI. Dr. Zharkov has stock in Novartis. Dr. Siegel has received personal compensation for serving as an employee of Novartis. Dr. Siegel has stock in Novartis. Mr. Cenni has received personal compensation for serving as an employee of Novartis. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunovant. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Johnson&Johnson / Janssen. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. Dr. Wiendl has received personal compensation in the range of $0-$499 for serving as a Consultant for Idorsia. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Actelion. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Argenx. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gossamer Bio. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunic. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NexGen. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for PSI CRO. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Worldwide Clinical Trials. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BD. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Serono. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz. The institution of Dr. Wiendl has received research support from Biogen. The institution of Dr. Wiendl has received research support from Roche. The institution of Dr. Wiendl has received research support from Deutsche Forschungsgemeinschaft. The institution of Dr. Wiendl has received research support from European Union. The institution of Dr. Wiendl has received research support from Alexion. The institution of Dr. Wiendl has received research support from Argenx. The institution of Dr. Wiendl has received research support from CSL Behring. The institution of Dr. Wiendl has received research support from Merck. The institution of Dr. Wiendl has received research support from UCB. Dr. Wiendl has received publishing royalties from a publication relating to health care. Dr. Wiendl has received publishing royalties from a publication relating to health care. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alakos. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aralez. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ArgenX. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BioCryst. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Blueprint. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celldex. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CSL Behring. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for FAES. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kalvista. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Menarini. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Moxie. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pharvaris. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi/Regeneron. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shire/Takeda. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ThirdHarmonicBio. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for URIACH. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AstraZeneca. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Blueprint. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharvaris. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Shire/Takeda. Marcus Maurer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for URIACH. Prof. Gimenez-Arnau has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Uriach Pharma. Prof. Gimenez-Arnau has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis . Prof. Gimenez-Arnau has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SAnofi Regeneron . Prof. Gimenez-Arnau has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Thermo Fisher . Prof. Gimenez-Arnau has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Almirall. Prof. Gimenez-Arnau has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CElldex . Prof. Gimenez-Arnau has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Uriach Pharma. Prof. Gimenez-Arnau has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Novartis . Prof. Gimenez-Arnau has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi . Prof. Gimenez-Arnau has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Menarini . The institution of Prof. Gimenez-Arnau has received research support from Instituto CArlos III. The institution of Prof. Gimenez-Arnau has received research support from URIACH . The institution of Prof. Gimenez-Arnau has received research support from NOVARTIS . Prof. Gimenez-Arnau has received publishing royalties from a publication relating to health care. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck/ EMD Serono. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Hoffmann-La Roche. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Actelion/ Janssen. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for BMS/ Celgene. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi/ Genzyme. Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Actelion/ Janssen. Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS/ Celgene. Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck/ EMD Serono. Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hoffmann-La Roche. Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Genzyme. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic Therapeutics. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Viatris/ Mylan. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz. The institution of Dr. Montalban has received research support from Biogen. The institution of Dr. Montalban has received research support from Hoffmann-La Roche. The institution of Dr. Montalban has received research support from Sanofi/ Genzyme. The institution of Dr. Montalban has received research support from Merck/ EMD Serono. The institution of Dr. Montalban has received research support from Novartis. The institution of Dr. Montalban has received research support from Teva Pharmaceuticals. The institution of Dr. Montalban has received research support from Actelion/ Janssen. The institution of Dr. Montalban has received research support from BMS/ Celgene.

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