60 - Impact of Holding Immunosuppressive Therapy in Patients With Inflammatory Bowel Disease (IBD) Around the Time of mRNA COVID-19 Vaccine Administration on Humoral Immune Response and Development of COVID-19 Infection

Wednesday, October 26, 2022

9:20 AM – 9:30 AM ET

Location: Hall C2

Presenting Author(s)

Kiran Motwani, MD

University of Maryland Medical Center
Baltimore, MD

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Award: ACG Governors Award for Excellence in Clinical Research (Trainee)

Kiran Motwani, MD¹, Jana G. Hashash, MD, MSc², Francis A. Farraye, MD, MSc, MACG³, Michael Kappelman, MD⁴, Kimberly Weaver, MD⁴, Xian Zhang, PhD⁵, Millie Long, MD, MPH, FACG⁶, Raymond Cross, MD¹
¹University of Maryland Medical Center, Baltimore, MD; ²Mayo Clinic Florida, Jacksonville, FL; ³Mayo Clinic, Jacksonville, FL; ⁴University of North Carolina at Chapel Hill, Chapel Hill, NC; ⁵University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC; ⁶UNC Chapel Hill, Chapel Hill, NC

Introduction: The BNT162b2 and mRNA-1273 vaccines are efficacious in patients with IBD; however, there is ongoing debate as to whether holding immunosuppressive therapy before and after immunization leads to better immune response. We sought to evaluate the effect of holding IBD medications around the time of vaccination on antibody response and subsequent COVID-19 infection.

Methods: We reviewed data collected from the prospective cohort, Partnership to Report Effectiveness of Vaccination in populations Excluded from iNitial Trials of COVID (PREVENT-COVID). Quantitative measurement of anti-receptor binding domain (anti-RBD) IgG antibodies to SARS-CoV-2 was performed 8 weeks after completing the vaccination series using the LabCorp Cov2Quant IgG assay. Patients were excluded if they were < 16 years, received the Ad26.COV2.S vaccine, on steroids, prior COVID-19 infection, or nucleocapsid antibody positive.

Results: A total of 1,768 patients were included; 69% with Crohn’s disease and 73% females. 49% were on anti-TNF monotherapy, 11% on combination therapy (anti-TNF and immunomodulator), 11% on vedolizumab, and 14% on ustekinumab. 11% of participants held therapy before or after vaccine administration. Continuing versus holding anti-TNF before or after the second vaccine made no difference on anti-RBD antibody titer in those receiving BNT162b2 (9.9 mg/mL vs 10.2 mg/mL) or mRNA-1273 (17 mg/mL vs 14 mg/mL). There was also no difference in titer in those on combination therapy if therapy was continued or held (BNT162b2: 5.3 mg/mL vs 4 mg/mL; mRNA-1273: 15 mg/mL vs 18 mg/mL). Antibody titers in those on novel biologics (ustekinumab or vedolizumab) were higher compared to participants treated with other therapies and were increased in those that held therapy around the time of vaccination. However, the difference if drug was continued or held was not statistically significant (BNT162b2: 22 mg/mL vs 29 mg/mL, mRNA-1273: 51 mg/mL vs 88.5 mg/mL, respectively). Holding therapy was not associated with decreased rate of breakthrough COVID-19 infection compared to those not holding therapy (BNT162b2: 24% vs 24%; mRNA-1273 13% vs 20%). None of the participants were hospitalized for COVID-19.

Discussion: Holding immunosuppressive therapy before or after mRNA COVID-19 vaccine dosing has no significant impact on anti-RBD antibody titers and does not impact the rate of breakthrough COVID-19 infections or hospitalizations. We recommend continuing IBD medications while receiving mRNA COVID-19 vaccination.

Initial COVID-19 Antibody Titers by Whether Medication was Held Before Second Vaccine
	BNT162b2						P value	mRNA-1273						P value
	Medication Held			Mediation Not Held				Medication Held			Medication Not Held
	Total N	Post Vaccination Titer Median IQR		Total N	Post Vaccination Titer Median IQR			Total N	Post Vaccination Titer Median IQR		Total N	Post Vaccination Titer Median IQR
Anti-TNF	15	8.5	3.6, 19.0	426	9.9	4.5, 16.0	0.872	7	14	9.0, 24.0	228	17	9.7, 28.0	0.676
Combo therapy (TNF + thiopurine or MTX)	4	4.45	2.0, 10.2	110	5.1	2.3, 13.0	0.764	3	18	10.0, 23.0	73	15	6.7, 22.0	0.541
Novel Biologic (Uste or Vedo)	6	62	39.0, 161.0	264	22	13.0, 40.0	0.038	7	119	89.0, 203.0	167	51	28.0, 99.0	0.026
Thiopurine Only	4	12.65	8.3, 22.5	112	15	7.1, 23.5	0.976	4	55.5	38.5, 68.0	68	35.5	20.5, 66.0	0.434
Methotrexate Only	4	23	16.5, 105.0	22	18.5	13.0, 34.0	0.505	1	74	74.0, 74.0	15	69	21.0, 101.0	1.000
Tofacitinib	0	n/a	n/a	20	15	8.9, 19.0	-	2	47.5	21.0, 74.0	6	74.5	66.0, 78.0	0.632
Initial COVID-19 Antibody Titers by Whether Medication was Held After Second Vaccine
	BNT162b2						P value	mRNA-1273						P value
	Medication Held			Medication Not Held				Medication Held			Medication Not Held
	Total N	Post Vaccination Titer Median IQR		Total N	Post Vaccination Titer Median IQR			Total N	Post Vaccination Titer Median IQR		Total N	Post Vaccination Titer Median IQR
Anti-TNF	38	11	4.4, 19.0	403	9.8	4.5, 16.0	0.759	25	14	9.0, 27.0	210	17	9.7, 28.0	0.405
Combo therapy (TNF + thiopurine or MTX)	11	4	1.9, 6.4	103	5.3	2.3, 13.0	0.343	5	18	10.0, 23.0	71	15	6.7, 22.0	0.587
Novel Biologic (Uste or Vedo)	16	22.5	16.0, 49.0	254	22	13.0, 40.0	0.786	14	88.5	36.0, 119.0	160	51	28.5, 99.0	0.238
Thiopurine Only	4	9.65	8.3, 19.5	112	15	7.1, 23.5	0.763	5	49	28.0, 62.0	67	37	20.0, 69.0	0.732
Methotrexate Only	7	26	16.0, 148.0	19	19	11.0, 33.0	0.205	1	74	74.0, 74.0	15	69	21.0, 101.0	1.000
Tofacitinib	0	n/a	n/a	20	15	8.9, 19.0	-	2	47.5	21.0, 74.0	6	74.5	66.0, 78.0	0.632
Initial COVID-19 Antibody Titers by Whether Medication was Held Before or After Second Vaccine
	BNT162b2						P value	mRNA-1273						P value
	Medication Held			Medication Not Held				Medication Held			Medication Not Held
	Total N	Post Vaccination Titer Median IQR		Total N	Post Vaccination Titer Median IQR			Total N	Post Vaccination Titer Median IQR		Total N	Post Vaccination Titer Median IQR
Anti-TNF	42	10.15	4.4, 19.0	399	9.9	4.5, 16.0	0.833	27	14	9.0, 27.0	208	17.5	9.9, 28.5	0.255
Combo therapy (TNF + thiopurine or MTX)	13	4	1.9, 6.4	101	5.3	2.5, 13.0	0.369	5	18	10.0, 23.0	71	15	6.7, 22.0	0.587
Novel Biologic (Uste or Vedo)	22	29	18.0, 48.0	248	22	13.0, 40.0	0.285	14	88.5	36.0, 119.0	160	51	28.5, 99.0	0.238
Thiopurine Only	5	10	9.3, 16.0	111	15	7.0, 24.0	0.823	6	54.5	28.0, 62.0	66	35.5	20.0, 69.0	0.556
Methotrexate Only	8	23	17.0, 120.0	18	18.5	11.0, 33.0	0.213	1	74	74.0, 74.0	15	69	21.0, 101.0	1.000
Tofacitinib	0	n/a	n/a	20	15	8.9, 19.0	-	2	47.5	21.0, 74.0	6	74.5	66.0, 78.0	0.632

Table: Antibody titers based on whether IBD therapy was held before, after, or any time before or after second BNT162b2 and mRNA-1273 COVID-19 vaccine administration.

Disclosures:

Kiran Motwani indicated no relevant financial relationships.

Jana Hashash indicated no relevant financial relationships.

Francis Farraye: Adiso Therapeutics – DSMB. BMS – Advisory Committee/Board Member. Boehringer Ingelheim – Advisory Committee/Board Member. Braintree – Advisory Committee/Board Member. GSK – Advisory Committee/Board Member. IBD Educational Group – Advisory Committee/Board Member. Innovation Pharmaceuticals – Stock Options. Iterative Scopes – Advisory Committee/Board Member. Janssen – Advisory Committee/Board Member. Lilly – DSMB. Pfizer – Advisory Committee/Board Member. Sebela – Advisory Committee/Board Member. Theravance – DSMB.

Michael Kappelman: Abbvie – Consultant. Eli Lilly – Consultant. Janssen – Consultant, Stock-publicly held company(excluding mutual/index funds). Pfizer – Consultant. Takeda – Consultant.

Kimberly Weaver: AbbVie – Consultant. Bristol Myers Squibb – Consultant.

Xian Zhang indicated no relevant financial relationships.

Millie Long: AbbVie – Consultant. Bristol Myers Squibb – Consultant. Calibr – Consultant. Eli Lilly – Consultant. Genentech – Consultant. Janssen – Consultant. Pfizer – Consultant, Grant/Research Support. Prometheus – Consultant. Roche – Consultant. Salix – Consultant. Takeda – Consultant, Grant/Research Support. Target RWE – Consultant. Theravance – Consultant.

Raymond Cross: Abbvie – Advisory Committee/Board Member, Consultant. BMS – Advisory Committee/Board Member. Fzata – Consultant. Janssen – Advisory Committee/Board Member, Grant/Research Support. Magellan Health – Consultant. Pfizer – Advisory Committee/Board Member, Consultant. Samsung bioepis – Consultant. Takeda – Advisory Committee/Board Member.

Kiran Motwani, MD¹, Jana G. Hashash, MD, MSc², Francis A. Farraye, MD, MSc, MACG³, Michael Kappelman, MD⁴, Kimberly Weaver, MD⁴, Xian Zhang, PhD⁵, Millie Long, MD, MPH, FACG⁶, Raymond Cross, MD¹, 60, Impact of Holding Immunosuppressive Therapy in Patients With Inflammatory Bowel Disease (IBD) Around the Time of mRNA COVID-19 Vaccine Administration on Humoral Immune Response and Development of COVID-19 Infection, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.