Abstract Background Hormonal fluctuations during the menstrual cycle (MC) may influence Crohn’s disease (CD) symptoms, potentially confounding treatment efficacy assessments. While prior studies have described MC-related symptom variability in CD, comprehensive real-world, multinational patient-reported data quantifying the prevalence, timing, and severity of these fluctuations remain limited. This study investigated the relationship between MCs, CD symptom changes, and their impact on quality of life (QoL). Methods A cross-sectional survey was conducted via the Carenity patient community platform, targeting women aged 18-50 years with moderate-to-severe CD who were receiving treatment. From 102 initial responses across France, the US, and the UK, 61 participants met the inclusion criteria following data review. Respondents reported symptom changes during menstruation, the timing of exacerbation, persistence during remission, and the impact on QoL in close-ended questions. Analysis included descriptive statistics and correlation assessment between symptom severity and QoL using weighted scoring methods. Results Among participants, 64% received biologics (e.g., anti-TNF, IL-12/23 inhibitors), 34% immunomodulators (e.g., azathioprine, 6-MP, methotrexate), 15% corticosteroids, 8% 5-ASA, and 2% investigational therapy in a clinical trial. Most respondents (87%) reported symptom changes related to their MC, with 48% indicating the most significant changes occurred during menstruation and 38% during the premenstrual week. CD symptoms reported as most changed during the MC were fatigue, abdominal pain, joint pain, nausea, and constipation with 94%, 82%, 74%, 74%, and 71% of respondents reporting either slight or significant change, respectively. Notably, 73% of respondents reported a moderate-to-very severe impact of their MC on CD-related QoL. The weighted scoring method, based on data-driven frequency of symptoms changes, applied to QoL correlation identified fatigue and stool frequency as the strongest drivers of QoL related to CD and MC. Conclusion The MC has a significant impact on CD symptom severity, influencing overall QoL. These findings underscore the importance of considering the MC when evaluating treatment response and symptom variability in both clinical trials and clinical practice. Integrating MC data may enhance the interpretation of treatment outcomes and support more personalized care for women with CD. Future research could explore incorporating menstrual cycle tracking and symptom pattern analysis into treatment planning, as this may help inform adjustments in timing, dosage, or supportive therapies during phases of heightened symptom severity to improve outcomes for women with IBD. Conflict of interest: Ligoudhi, Ihsane: Ihsane Ligoudhi is contractor at Sanofi Bondoux, Laurence: LJB is Sanofi employee and may hold shares and/or stock options in the company. Mrs. Lucats, Laurence: LL is a Sanofi employee and may hold shares and/or stock options in the company. Rekhtman, Yuliya: YR is a Sanofi employee and may hold shares and/or stock options in the company. Cross, Sarah: SC is Sanofi employee and may hold shares and/or stock options in the company. Hajdukova, Eva: EH is Sanofi conractor
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