P538 Pregnancy outcomes in women with psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis treated with ustekinumab

Abstract Background Ustekinumab (UST) is indicated for psoriasis (PSO), psoriatic arthritis (PsA), Crohn’s disease (CD), and ulcerative colitis (UC). The recommended dose in CD/UC is generally higher than in PSO/PsA. No adverse pregnancy outcomes were observed in preclinical studies.1 Here we present pregnancy outcomes from spontaneous reporting, clinical studies and registries. Methods This dataset includes pregnancies with maternal exposure to UST during pregnancy or within 3 months prior to conception reported to the manufacturer through April 2019. Results Overall, 478 maternal pregnancies (334 PSO, 124 CD, 11 UC, 9 PsA) were identified. Mean maternal age was 30.5 years. Most pregnancies (71.3%) resulted in live births (LB, [including 20 preterm births; PTB]). Spontaneous abortion (SA) was reported in 18.4% of cases. Congenital anomalies (CA) were reported in 3.8% (3.3% major CA [MCA]). Pregnancies with UST exposure throughout gestation (12.1%) resulted in 55 (94.8%) LB including 4 (7.3%) PTB, and 5 (8.6%) MCA. Among pregnancies with exposure in Trimester 1 (66.5%), 207 (65.1%) LB including 11 (5.3%) PTB, and 2 (0.6%) MCA were reported. Among PSO/PsA maternal pregnancies, rates were 72.3% LB, 2.0% CA (1.4% MCA), and 16.9% SA; among CD/UC maternal pregnancies, rates were 68.9% LB, 4.4% MCA and 22.2% SA. Conclusion Pregnancy outcome data following maternal exposure to UST showed that the prevalence of live births, spontaneous abortions and congenital anomalies were consistent with the general population and TNFi therapies. Pregnancy outcomes in women with CD/UC and PSO/PsA were generally comparable. No apparent safety signals were noted with exposure throughout pregnancy. Reference

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Sa1827 PREGNANCY OUTCOMES IN WOMEN WITH PSORIASIS, PSORIATIC ARTHRITIS, CROHN'S DISEASE AND ULCERATIVE COLITIS TREATED WITH USTEKINUMAB

Gastroenterology ◽

10.1016/s0016-5085(20)31787-x ◽

2020 ◽

Vol 158 (6) ◽

pp. S-442

Author(s):

Sheri Volger ◽

Ilia Tikhonov ◽

Connie Lin ◽

Christopher D. O'Brien ◽

Colleen W. Marano ◽

...

Keyword(s):

Ulcerative Colitis ◽

Crohn’S Disease ◽

Psoriatic Arthritis ◽

Crohn's Disease ◽

Pregnancy Outcomes

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178 PREGNANCY OUTCOMES IN WOMEN EXPOSED TO USTEKINUMAB IN THE CROHN'S DISEASE AND ULCERATIVE COLITIS CLINICAL TRIALS

Gastroenterology ◽

10.1016/s0016-5085(21)00849-0 ◽

2021 ◽

Vol 160 (6) ◽

pp. S-43

Author(s):

Bincy P. Abraham ◽

Elyssa Ott ◽

Christopher Busse ◽

Conor J. Murphy ◽

Lindsay Miller ◽

...

Keyword(s):

Ulcerative Colitis ◽

Clinical Trials ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Pregnancy Outcomes

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Psoriasis and inflammatory bowel diseases: pathogenetic pathways and the choice of biologic therapy (a literature review)

Almanac of Clinical Medicine ◽

10.18786/2072-0505-2019-47-062 ◽

2019 ◽

Vol 47 (6) ◽

pp. 568-578 ◽

Cited By ~ 2

Author(s):

L. S. Kruglova ◽

A. N. Lvov ◽

A. V. Kagramanova ◽

O. V. Knyazev

Keyword(s):

Ulcerative Colitis ◽

Crohn’S Disease ◽

Psoriatic Arthritis ◽

Crohn's Disease ◽

Genetically Engineered ◽

Evidence Level ◽

Frequent Administration ◽

Bowel Diseases ◽

Inflammatory Bowel ◽

Effector Cytokines

Psoriasis and inflammatory bowel disease (IBD) are multifactorial chronic immuno-inflammatory potentially disabling disorders with similar genetic factors and immunological pathways, in particular, genetic polymorphisms of IL-23R, which determines the signal IL-12/23-mediated pathway of immunopathogenesis. The emergence of genetically engineered biological agents has changed the prognosis for both psoriasis and IBD. The intersection of the therapeutic spectrum in psoriasis and IBD is a very important point when choosing the management strategy for these patients. Infliximab and adalimumab are effective in the treatment of psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis (evidence level 1A). Ustekinumab demonstrates effectiveness in the treatment of psoriasis, psoriatic arthritis (evidence level 1A) and Crohn's disease (evidence level 1B). Etanercept and secukinumab have been shown to be effective against psoriasis, psoriatic arthritis (evidence level 1A) and ineffective and even associated with exacerbation risk in Crohn's disease and ulcerative colitis. Inhibition of regulatory cytokines IL-12/23 also has a number of advantages compared to the blockade of effector cytokines (TNF-α, IL-17) due to potentially long-term and stable treatment results and less frequent administration.

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Sa544 THE BURDEN OF WORK PRODUCTIVITY AND ACTIVITY IMPAIRMENT IN CROHN'S DISEASE, ULCERATIVE COLITIS, PSORIASIS AND PSORIATIC ARTHRITIS

Gastroenterology ◽

10.1016/s0016-5085(21)02000-x ◽

2021 ◽

Vol 160 (6) ◽

pp. S-543

Author(s):

David Hudesman ◽

Philip Mease ◽

Mark Lebwohl ◽

Anita M. Loughlin ◽

Page C. Moore ◽

...

Keyword(s):

Ulcerative Colitis ◽

Crohn’S Disease ◽

Psoriatic Arthritis ◽

Crohn's Disease ◽

Work Productivity ◽

Activity Impairment

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DOP53 Pregnancy outcomes in the ozanimod clinical development program in relapsing multiple sclerosis, Ulcerative Colitis, and Crohn’s Disease

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab073.092 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S088-S089

Author(s):

M C Dubinsky ◽

U Mahadevan ◽

L Charles ◽

S Afsari ◽

A Henry ◽

...

Keyword(s):

Multiple Sclerosis ◽

Ulcerative Colitis ◽

Crohn’S Disease ◽

Pregnancy Outcomes ◽

Development Program ◽

Clinical Development ◽

Study Medication ◽

Live Births ◽

Clinical Development Program ◽

Relapsing Multiple Sclerosis

Abstract Background Ozanimod, an oral sphingosine 1-phosphate (S1P) receptor modulator selectively targeting S1P1 and S1P5, has demonstrated efficacy in patients with relapsing multiple sclerosis (rMS) and ulcerative colitis (UC), and is being studied in Crohn’s disease (CD). S1P1-3 receptors are involved in vascular formation during embryogenesis. Within studies in the ozanimod clinical development program, female participants of childbearing potential were required to use effective contraception while receiving and up to 3 months after discontinuing ozanimod; treatment discontinuation was required if pregnancy was confirmed. Here we review pregnancy outcomes data with ozanimod use in rMS, UC, and CD. Methods All pregnancies, including participant and partner pregnancies, in the ozanimod clinical development program with an initial diagnosis prior to a cut-off date of September 30, 2020 were assessed for pregnancy outcomes. Results At cut-off, safety data on 4131 participants were available. A total of 83 pregnancies were reported in the safety database of participants treated with ozanimod or their partners (Table). All pregnancy exposures occurred during the first trimester. Of the 60 pregnancies in ozanimod clinical trials, 9 were reported in patients with UC, and 3 in patients with CD. Participants discontinued study medication promptly except for those who elected pregnancy termination and did not discontinue study medication. Among all pregnancies in the ozanimod clinical development program, the incidence of spontaneous abortion in clinical trial participants was 15%; the rate in the general population is between 12% and 22%. The rate of preterm birth was 10.7% of live births; as reference, the global population estimate is 10.6% and the European estimate is 8.7%. No teratogenicity was observed. Outcomes in patients with UC included 2 live births that resulted in 2 full-term healthy newborns, 2 ongoing pregnancies, 2 spontaneous early losses, and 3 elective terminations. Conclusion While pregnancy should be avoided in patients on and 3 months after stopping ozanimod and clinical experience with ozanimod during pregnancy is limited, there has been no increased event of foetal abnormalities or adverse pregnancy outcomes seen with ozanimod exposure in early pregnancy.

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S930 Safety of Ustekinumab Across Approved Adult Indications: Pooled Safety Analysis in Crohn’s Disease, Ulcerative Colitis, Psoriasis, and Psoriatic Arthritis Through up to 5 Years

The American Journal of Gastroenterology ◽

10.14309/01.ajg.0000777252.35443.aa ◽

2021 ◽

Vol 116 (1) ◽

pp. S441-S441

Author(s):

Millie D. Long ◽

Silvio Danese ◽

Elyssa Ott ◽

Christopher Gasink ◽

Ye Miao ◽

...

Keyword(s):

Ulcerative Colitis ◽

Crohn’S Disease ◽

Psoriatic Arthritis ◽

Crohn's Disease ◽

Safety Analysis

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Risk of uveitis and inflammatory bowel disease in people with psoriatic arthritis: a population-based cohort study

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2017-212328 ◽

2017 ◽

Vol 77 (2) ◽

pp. 277-280 ◽

Cited By ~ 17

Author(s):

Rachel Charlton ◽

Amelia Green ◽

Gavin Shaddick ◽

Julia Snowball ◽

Alison Nightingale ◽

...

Keyword(s):

Ulcerative Colitis ◽

Inflammatory Bowel Disease ◽

Cohort Study ◽

Crohn’S Disease ◽

Psoriatic Arthritis ◽

Crohn's Disease ◽

General Population ◽

Bowel Disease ◽

Inflammatory Bowel ◽

Incident Cases

ObjectivesTo determine the risk of uveitis and inflammatory bowel disease (IBD) in patients with psoriatic arthritis (PsA) compared with the general population and patients with psoriasis.MethodsA cohort study using data from the UK Clinical Practice Research Datalink between 1998 and 2014. Patients with incident PsA aged 18–89 years were identified and matched to a cohort of patients with psoriasis and a general population cohort. The incidence of uveitis, all IBD, Crohn’s disease and ulcerative colitis was calculated for each study cohort and adjusted relative risks (RRadj) were calculated using conditional Poisson regression.Results6783 incident cases of PsA were identified with a median age of 49 years. The risk of uveitis was significantly higher in the PsA cohort than in the general population and psoriasis cohorts (RRadj 3.55, 95% CI 2.21 to 5.70 and RRadj 2.13, 95% CI 1.40 to 3.24, respectively). A significant increase was observed for Crohn’s disease (RRadj 2.96, 95% CI 1.46 to 6.00 and RRadj3.60, 95% CI 1.83 to 7.10) but not for ulcerative colitis (RRadj1.30, 95% CI 0.66 to 2.56 and RRadj0.98, 95% CI 0.50 to 1.92).ConclusionsIn a primary care-based incidence cohort of patients with PsA, there were substantial risks of developing uveitis and/or Crohn’s disease, but not ulcerative colitis, when compared with the general population and psoriasis controls.

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