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Oral Paper Presentation

Annual Scientific Meeting

Session: Plenary Session 3A - IBD

43 - Maternal and Neonatal Outcomes in Vedolizumab and Ustekinumab Exposed Pregnancies: Results From the PIANO Registry

Tuesday, October 25, 2022

3:15 PM – 3:25 PM ET

Location: Hall C2

Presenting Author(s)

Rishika Chugh, MD

University of California San Francisco
San Francisco, CA

PDF of Slides View Slides

Award: Outstanding Research Award in the IBD Category (Trainee)

Rishika Chugh, MD¹, Millie Long, MD, MPH, FACG², Kimberly Weaver, MD³, Dawn Beaulieu, MD⁴, Ellen J. Scherl, MD⁵, Uma Mahadevan, MD¹
¹University of California San Francisco, San Francisco, CA; ²UNC Chapel Hill, Chapel Hill, NC; ³University of North Carolina at Chapel Hill, Chapel Hill, NC; ⁴Vanderbilt University Medical Center, Nashville, TN; ⁵Weill Cornell Medicine, New York Presbyterian Hospital, New York, NY

Introduction: Pregnancy outcomes in IBD patients with quiescent disease are similar to the general population. Data from the Pregnancy Inflammatory bowel disease And Neonatal Outcomes (PIANO) registry have demonstrated the safety of anti-tumor necrosis factor alpha (TNFs) and thiopurines in pregnancy. The objective of this study is to provide updated information from the PIANO registry on maternal and fetal outcomes in patients exposed to ustekinumab (UST) and vedolizumab (VDZ).

Methods: In this multicenter prospective observational study, we included pregnant women with singleton pregnancies and a diagnosis of inflammatory bowel disease. Questionnaires were administered to women at study intake, each subsequent trimester, delivery, and at 4, 9, and 12 months after birth. Bivariate analyses were utilized to determine the independent effects of specific drug classes on outcomes. The exposure cohorts were VDZ, UST, TNFs, immunomodulators, and combination with biologics and immunomodulators. All were compared to no exposure to biologics/immunomodulators.

Results: There were 1642 completed pregnancies with 1581 live births. Maternal mean age was 32.1±4.6 years at delivery with 62 VDZ and 43 UST exposed. Women on UST were more likely to have Crohn’s disease. There was no increased risk of spontaneous abortion, small for gestational age, low birth weight, neonatal intensive care unit stay, congenital malformations, or intrauterine growth restriction with in utero VDZ or UST exposure [Table 1]. The rate of preterm birth was 0% in UST, 12.7% VDZ, 8.2% TNFs, and 9.7% in the unexposed cohort (p = 0.037). Rates of serious and non-serious infections at birth and within the first 12 months of life were comparable among all groups, with an increase in nonserious infections in VDZ group at 4 months, which did not persist at 1 year. There was no increased risk of placental complications in the VDZ cohort compared to the unexposed cohort. UST infant concentrations at birth were increased whereas VDZ concentrations were overall decreased compared to maternal serum drug concentrations.

Discussion: An updated analysis of UST and VDZ exposure during pregnancy suggests no increase in complications compared to TNFs, immunomodulators and combination of biologics with immunomodulators. UST was associated with lower rates of preterm birth and Cesarean section. No signal was found for increased placental events with either therapy. Continuation of UST and VDZ during pregnancy is recommended.

Pregnancy Events

(% yes)

No exposure

(n = 430)

Anti-TNFs

(n = 700)

Immuno-modulators

(n = 226)

Combination: Biologics + Immunomodulators

(n = 179)

UST

(n = 43)

VDZ

(n = 62)

p-value

Any pregnancy complication

86 / 401

(21.4%)

123 / 649

(19.0%)

42 / 208

(20.2%)

28 / 169

(16.6%)

10 / 39

(25.6%)

10 / 59

(16.9%)

0.663

SAB (gestation ages ≤140 days)

9 / 234

(3.8%)

18 / 438

(4.1%)

6 / 136

(4.4%)

2 / 109

(1.8%)

2 / 21

(9.5%)

1 / 30

(3.3%)

0.675

SAB (all gestation ages)

11 / 429

(2.6%)

18 / 697

(2.6%)

7 / 226

(3.1%)

2 / 178

(1.1%)

2 / 43

(4.7%)

1 / 62

(1.6%)

0.739

Preterm birth (< 37 weeks)

38 / 391

(9.7%)

53 / 643

(8.2%)

25 / 204

(12.3%)

24 / 166

(14.5%)

0 / 38

(0.0%)

7 / 55

(12.7%)

0.037

Small for gestational age

16 / 383

(4.2%)

31 / 579

(5.4%)

5 / 202

(2.5%)

3 / 147

(2.0%)

1 / 14

(7.1%)

2 / 35

(5.7%)

0.356

LBW (< 2500 g)

21 / 380

(5.5%)

38 / 635

(6.0%)

9 / 206

(4.4%)

8 / 159

(5.0%)

1 / 38

(2.6%)

6 / 55

(10.9%)

0.493

Intrauterine growth restriction

11 / 429

(2.6%)

13 / 700

(1.9%)

1 / 226

(0.4%)

4 / 179

(2.2%)

0 / 43

(0.0%)

1 / 62

(1.6%)

0.455

Cesarean section

154 / 394

(39.1%)

292 / 650

(44.9%)

93 / 208

(44.7%)

90 / 168

(53.6%)

12 / 38

(31.6%)

26 / 55

(47.3%)

0.024

NICU at birth

58 / 397

(14.6%)

107 / 651

(16.4%)

31 / 209

(14.8%)

29 / 168

(17.3%)

4 / 37

(10.8%)

8 / 55

(14.5%)

0.879

Congenital malformations

28 / 268

(10.4%)

61 / 581

(10.5%)

19 / 150

(12.7%)

18 / 153

(11.8%)

7 / 39

(17.9%)

8 / 59

(13.6%)

0.715

Any of the above

275 / 430

(64.0%)

477 / 700

(68.1%)

156 / 226

(69.0%)

128 / 179

(71.5%)

28 / 43

(65.1%)

42 / 62

(67.7%)

0.513

Abruptio Placenta

3 / 198

(1.5%)

5 / 302

(1.7%)

1 / 93

(1.1%)

1 / 75

(1.3%)

0 / 13

(0.0%)

0 / 31

(0.0%)

>0.999

Pre-Eclampsia/

Eclampsia

18 / 198

(9.1%)

30 / 302

(9.9%)

13 / 93

(14.0%)

7 / 75

(9.3%)

2 / 13

(15.4%)

4 / 31

(12.9%)

0.512

Placenta previa

5 / 197

(2.5%)

9 / 302

(3.0%)

2 / 93

(2.2%)

1 / 75

(1.3%)

0 / 13

(0.0%)

2 / 31

(6.5%)

0.243

Hemorrhage

5 / 197

(2.5%)

5 / 302

(1.7%)

5 / 93

(5.4%)

2 / 75

(2.7%)

3 / 13

(23.1%)

0 / 31

(0.0%)

>0.999

Postpartum hemorrhage

6 / 197

(3.1%)

15 / 302

(2.1%)

1 / 93

(1.1%)

5 / 75

(6.7%)

0 / 13

(0.0%)

1 / 31

(3.2%)

>0.999

TNF: tumor necrosis factor, UST: ustekinumab, VDZ: vedolizumab, SAB: spontaneous abortion, LBW: low birth weight, g: grams, NICU: neonatal intensive care unit, vs: versus

Table: Table 1. Pregnancy Related Complications by Drug Exposure in completed pregnancies

Disclosures:

Rishika Chugh 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.

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

Dawn Beaulieu: Abbvie – Consultant. Takeda – Consultant.

Ellen Scherl: AbbVie – Consultant, Grant/Research Support. AstraZeneca – Grant/Research Support. Bristol Myers Squibb – Consultant. Celgene – Grant/Research Support. Crohn’s and Colitis Foundation – Consultant, Grant/Research Support. Entera Health – Consultant. Evidera – Consultant. Genentech – Grant/Research Support. GI Health Foundation – Consultant, Speakers Bureau. Gilead – Stock Options. Janssen Research & Development, LLC – Consultant, Grant/Research Support. Johns Hopkins University – Grant/Research Support. National Institute of Diabetes and Digestive and Kidney – Grant/Research Support. National Institute of Health – Grant/Research Support. New York Crohn’s Foundation – Grant/Research Support. Pfizer – Grant/Research Support. Protagonist – Consultant. Seres – Consultant, Grant/Research Support. Takeda – Consultant. UCB – Grant/Research Support.

Uma Mahadevan: Abbive – Consultant. Arena – Consultant. Boehringer Ingelheim – Grant/Research Support. Bristol Myers Squibb – Consultant. Gilead – Consultant. Janssen – Consultant. Lilly – Consultant. Pfizer – Consultant. Prometheus Biosciences – Grant/Research Support. Protagonist – Grant/Research Support. Surrozen – Grant/Research Support. Takeda – Consultant.

Rishika Chugh, MD¹, Millie Long, MD, MPH, FACG², Kimberly Weaver, MD³, Dawn Beaulieu, MD⁴, Ellen J. Scherl, MD⁵, Uma Mahadevan, MD¹, 43, Maternal and Neonatal Outcomes in Vedolizumab and Ustekinumab Exposed Pregnancies: Results From the PIANO Registry, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.