Clinical and Experimental Gastroenterology (May 2024)

Vedolizumab Safety During Pregnancy and Lactation in a Patient with Ulcerative Colitis: A Case Report

  • Pinto FPJ,
  • Dutra RDM,
  • Almeida LC,
  • Craveiro MMS,
  • Baima JP,
  • Saad-Hossne R,
  • Sassaki LY

Journal volume & issue
Vol. Volume 17
pp. 165 – 171

Abstract

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Fernanda Patrícia Jeronymo Pinto,1 Renata de Medeiros Dutra,1 Livia Cafundo Almeida,1 Marcela Maria Silvino Craveiro,2 Julio Pinheiro Baima,1 Rogerio Saad-Hossne,2 Ligia Yukie Sassaki1 1Department of Internal Medicine, São Paulo State University (Unesp), Medical School, Botucatu, São Paulo State, Brazil; 2Department of Surgery, São Paulo State University (Unesp), Medical School, Botucatu, São Paulo State, BrazilCorrespondence: Ligia Yukie Sassaki, Department of Internal Medicine, São Paulo State University (Unesp), Medical School, Botucatu, São Paulo State, 18618687, Brazil, Tel +551438801171, Email [email protected]: Inflammatory bowel disease (IBD) affects young adults of reproductive age, and questions related to pregnancy and breastfeeding are common in clinical practice. Most medications used to treat IBD are considered safe during pregnancy, except methotrexate and small molecules such as tofacitinib. Despite few studies regarding vedolizumab (VDZ) safety, it appears to be safe during pregnancy. Therefore, this study aimed to report the management of ulcerative colitis in pregnant patient refractory to anti-tumor necrosis factor (TNF) agents using VDZ.Case Report: A female, 38 years old, with ulcerative colitis was refractory to conventional treatment with mesalazine, sulfasalazine, and azathioprine. She was hospitalized at six weeks of gestation with severe acute colitis requiring the use of infliximab (IFX) to induce remission. She had a spontaneous abortion at nine weeks of gestation after the second dose of IFX. Since there was no endoscopic improvement after six months of IFX treatment, VDZ treatment was initiated. During the VDZ infusion period, the patient discovered that she was pregnant with twins, leading to the discussion of the risks and benefits of continuing the VDZ. The patient presented with disease clinical remission with the use of VDZ, and the babies were born at 34 weeks of gestation without complications. Breastfeeding was also performed without complications.Conclusion: Continued VDZ medication is safe during pregnancy and breastfeeding, with adverse events similar to anti-TNF therapy.Keywords: gestation, biological therapy, safety, inflammatory bowel disease

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