P768 Appropriateness of small molecule agents for patients with IBD of childbearing age – a RAND appropriateness panel

Abstract

Abstract Background Many women of childbearing age with IBD require advanced therapies. While biologics are largely low risk during pregnancy, the novel small molecules Tofacitinib, Filgotinib, Upadacitinib and Ozanimod (TFUO) have shown concerning reproductive results in animal studies. Therefore, their use in women of childbearing age needs careful consideration. Methods We convened a RAND appropriateness panel of 6 gastroenterologists, 2 IBD nurses, 1 IBD pharmacist and 3 expert patients. Following a literature review, 13 statements were drafted and voted upon in 2 rounds. Results 13 statements were voted on in two rounds. All statements were deemed appropriate after one round of revisions. Here we present a selection of key statements: 1. Women with IBD of childbearing age who wish to commence therapy with TFUO, need to use effective contraception. Counselling regarding the risk of TFUO in unplanned pregnancies should be provided. 2. For women using contraception while on JAK therapy, we suggest the preferred use of progesterone-only or non-hormonal long-acting contraception over combined oestrogen-progesterone formulations to reduce the risk of venous thromboembolism. 3. TFUO are contraindicated during pregnancy due to serious teratogenicity concerns. 4. Regardless of physical wash out periods, we recommend that women currently receiving TFUO cease therapy with enough time to establish clinical remission ideally for at least 3 months prior to conception. This window allows to safely establish whether the alternative (or no) therapy can maintain remission. 5. Therapies other than TFUO should be considered as first line therapy in women with IBD of childbearing age, with the exception of select individual social or medical circumstances, or women who have completed family planning and agree to use effective contraception. 6. TFUO may be appropriate choices for women of childbearing age after failure of, intolerance of or contraindications to one biological agent licensed for IBD. 7. In women who wish to have children in the future, a minimum treatment period for TFUO should be considered. Where the wish to start a family is less than 1 year in the future it is recommended to consider agents other than TFUO. 8. TFUO are contraindicated during breastfeeding. 9. If a woman conceives while taking TFUO, the medication should be ceased, she should receive counselling about potential known and unknown maternofoetal complications, and alternative IBD therapy may be commenced if required. Conclusion We developed 13 practice statements derived from a RAND appropriateness panel of clinicians and patients to guide decision making for women of childbearing age regarding TFUO small molecules therapies for IBD.