Abstract Details

Title Safety of Non-MS Biologics in Patients with Multiple Sclerosis: A Multi-center Retrospective Study of MS Patients with Co-morbid Autoimmune Conditions

Topic Multiple Sclerosis

Presentation(s) S40 - Multiple Sclerosis: Clinical Trials/Science and Real-world Evidence (2:12 PM-2:24 PM)

Poster/Presentation
Number 007

Objective To assess the safety of non-MS biologics in patients with multiple sclerosis (MS) and co-morbid systemic autoimmune disease (AID).

Background

Systemic autoimmune disease (AID) occurs in 5-10% of the general population, and at an even higher rate in multiple sclerosis (MS). Biologic therapies are increasingly used for the treatment of AID. While TNFa inhibitors are contraindicated, the safety of many other biologics in MS is uncertain. The use of non-MS biologics is of special concern when prescribed in combination with MS disease-modifying therapies (DMTs).

Design/Methods

Retrospective chart review from 11 medical centers across the United States. Patients with MS who were treated with a biologic for a co-morbid AID were included.

Results We identified 190 patients with MS and AID who were treated with non-MS biologics (mean age [standard deviation]: 50.6 [12.7], female: 70%, mean MS disease duration: 11.57 years [10.9]). The most common AIDs were inflammatory bowel disease (37%), psoriasis (36%), and psoriatic arthritis (22%). The most commonly used biologics were anti-IL-12/IL-23s (37%), anti-IL-17s (27%), and anti-IL-23s (23%). The average time on a biologic was 3.0 years (for a total of 593.2 patient-years). In 152 patients (80%), an MS DMT was prescribed concurrently. There were 20 serious infections (3.4 per 100 patient-years). Other serious adverse events, such as malignancy and thromboembolism, were rare. Thirty-six clinical MS relapses were observed (6.1 per 100 patient-years). Detailed analysis on the updated cohort will be presented, including MS disease activity.

Conclusions Serious adverse events in patients with both MS and AID on non-MS biologics were rare, including among patients treated concurrently with an MS DMT. Our results may help inform care for patients with MS who require a non-MS biologic for management of a co-morbid AID.

Authors/Disclosures
Evan Madill, MD (Mass General Brigham) PRESENTER	The institution of Dr. Madill has received research support from ��ɫ��.
Kerry Lenzi, PharmD	Dr. Lenzi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics.
Kristin M. Galetta, MD (Stanford University)	Dr. Galetta has received personal compensation in the range of $0-$499 for serving as a Speaker with Can Do MS.
John A. Lincoln, MD, PhD (McGovern Medical School, UTHealth)	The institution of Dr. Lincoln has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Genzyme. Dr. Lincoln has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. The institution of Dr. Lincoln has received research support from Deaprtment of Defense. The institution of Dr. Lincoln has received research support from National Institutes of Health. The institution of Dr. Lincoln has received research support from EMD-Serono. Dr. Lincoln has received intellectual property interests from a discovery or technology relating to health care.
Erin Longbrake, MD, PhD, FAAN (Yale University)	Dr. Longbrake has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Longbrake has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Longbrake has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Longbrake has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Longbrake has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Longbrake has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Longbrake has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Longbrake 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. Longbrake has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for ACTRIMS. Dr. Longbrake has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Annals of Neurology. The institution of Dr. Longbrake has received research support from Genentech. The institution of Dr. Longbrake has received research support from NINDS K23. The institution of Dr. Longbrake has received research support from Robert Patterson Leet Trust. The institution of Dr. Longbrake has received research support from Biogen. The institution of Dr. Longbrake has received research support from National MS Society. The institution of Dr. Longbrake has received research support from Department of Defense. Dr. Longbrake has received personal compensation in the range of $500-$4,999 for serving as a Study Section Member with Department of Defense (CDMRP). Dr. Longbrake has received personal compensation in the range of $500-$4,999 for serving as a Programmatic Review with Department of Defense (CDMRP). Dr. Longbrake has received personal compensation in the range of $500-$4,999 for serving as a Study Section Member with National Institute of Health .
Gloria Von Geldern, MD, FAAN (University of Washington)	The institution of Dr. Von Geldern has received research support from Novartis. The institution of Dr. Von Geldern has received research support from Contineum Therapeutics. Dr. Von Geldern has received personal compensation in the range of $0-$499 for serving as a DSMB member with NIH, NINDS. Dr. Von Geldern has a non-compensated relationship as a editorial board member with MS and Related Disorders Journal that is relevant to AAN interests or activities.
Jacob A. Sloane, MD, PhD (Beth Israel Deaconess Medical Center)	Dr. Sloane has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for biogen. Dr. Sloane has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Sloane has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi.
Hamza Coban, MD (UConn Health Neurology)	Dr. Coban has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EMD Serono.
Asya I. Wallach, MD (Holy Name MS Center)	Dr. Wallach has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genetech. Dr. Wallach has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen.
Josef M. Gutman, MD (NYU Ambulatory Care Center East Meadow Neurology)	Dr. Gutman has nothing to disclose.
Nancy Le, PharmD	Dr. Le has received personal compensation in the range of $0-$499 for serving as a Consultant for TG Therapeutics, Inc. . Dr. Le has received personal compensation in the range of $500-$4,999 for serving as a Group Leader for ��ɫ��al Discussion with Argenx US Inc. .
Carolyn Akers, MD	Ms. Akers has nothing to disclose.
Raveena Vij	Miss Vij has nothing to disclose.
Tamar Bacon	The institution of an immediate family member of Tamar Bacon has received research support from Novartis. The institution of an immediate family member of Tamar Bacon has received research support from Genentech. An immediate family member of Tamar Bacon has received publishing royalties from a publication relating to health care.
Laura Naydovich, MD	Dr. Wolf has nothing to disclose.
Caitlin Pileggi, NP (Penn Medicine)	Mrs. Pileggi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Mrs. Pileggi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics.
Jeffrey Xi, MS	Mr. Xi has nothing to disclose.
Bruna de Freitas Dias, MD (Stanford university)	Dr. Dias has nothing to disclose.
Joshua Hobbs	Mr. Hobbs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Trinity LIfe Sciences . Mr. Hobbs has received research support from NIH.
Alexandra R. Balshi	Ms. Balshi has nothing to disclose.
Mary A. Picone, MD, FAAN (Holy Name Medical Center MS Center)	Dr. Picone has nothing to disclose.
Josephine Vonderhaar, BA, PharmD Candidate	Miss Vonderhaar has nothing to disclose.
Daniel Kantor, MD, FAAN (Medical Partnership 4 MS+)	Dr. Kantor has received personal compensation for serving as an employee of Gateway Institute for Brain Research. Dr. Kantor has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Kantor has a non-compensated relationship as a HAP with MSFous (MSF) that is relevant to AAN interests or activities. Dr. Kantor has a non-compensated relationship as a Medical Board with MS Views & News that is relevant to AAN interests or activities.
Shamik Bhattacharyya, MD, FAAN (Brigham and Women's Hospital)	Dr. Bhattacharyya has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NeuroLambda. Dr. Bhattacharyya has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion Pharmaceuticals. Dr. Bhattacharyya has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Bhattacharyya has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Bhattacharyya 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 Continuum. Dr. Bhattacharyya has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Wiley. Dr. Bhattacharyya has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Merck. The institution of Dr. Bhattacharyya has received research support from Alexion Pharmaceuticals. The institution of Dr. Bhattacharyya has received research support from National Institute of Health. The institution of Dr. Bhattacharyya has received research support from UCB. The institution of Dr. Bhattacharyya has received research support from Genentech. Dr. Bhattacharyya has received publishing royalties from a publication relating to health care. Dr. Bhattacharyya has received publishing royalties from a publication relating to health care.
Ilya Kister, MD, FAAN (NYU School of Medicine)	Dr. Kister has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech-Roche. Dr. Kister has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. The institution of Dr. Kister has received research support from Genentech. The institution of Dr. Kister has received research support from Novartis. Dr. Kister has received publishing royalties from a publication relating to health care.

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