P0277Menopause, menstruation, and IBD flare: Results from the PREdiCCt study

Background In PREdiCCt, the largest prospective study of IBD flare, female sex was strongly associated with increased patient-reported flares. Herein, we aimed to investigate associations between women’s health factors and disease flare. Methods Of 2629 participants, 1422 female patients in patient-reported remission were recruited from 47 UK sites and followed up prospectively for a minimum of 24 months. At study entry, patients completed questionnaires evaluating menstruation, menopause, and use of contraceptives/hormone therapy. Our primary objective was to determine the relationship between menopausal status and time to patient-reported or objective flare (CRP >5mg/L or FC > 250μg/g and change in treatment). We further investigated hormonal contraception use, menstrual patterns and symptoms, and IBD symptoms during menses with time to flare. Survival analyses with Cox frailty models were run adjusting for baseline FC and key clinical and demographic factors. Results We included 1044 patients [CD = 555, UC/IBDU=465] (Table 1). Pre-menopausal women had a higher baseline FC in clinical remission than post-menopausal women [p < 0.001 (Table 1)]. This association remains significant in a multivariable logistic regression model adjusted by age, disease duration, and biologic use (p = 0.037). Pre-menopausal patients with irregular menstrual cycles and those reporting increased rectal bleeding during menses had a higher baseline FC (p = 0.023 and p = 0.024 respectively). Conversely, hormonal contraceptive use was associated with a lower baseline FC (p = 0.016). The rates of objective flare were higher in pre- versus post-menopausal women on univariate analysis [17.1% vs 10.6%, p = 0.0048 (Fig. 1B)], but not in the multivariable model (p = 0.41). No significant differences were seen for patient-reported flare. Hormonal contraception was not associated with time to flare. Irregular menstrual cycle (variation ≥8 days) and prolonged menstrual period (>8 days) were associated with a shorter time to patient-reported [aHR 1.65 (1.19-2.30), p = 0.0029 (Fig. 1C) and aHR 2.22 (1.20-4.10), p = 0.011, respectively], but not objective flare. Similarly, women reporting increased rectal bleeding during menses had a shorter time to patient-reported flare [aHR 1.35 (1.00-1.82), p = 0.047 (Fig 1D)]. No other changes to IBD symptoms during menstruation were associated with time to flare. Conclusion The absence of associations between women’s health factors and objective flares in PREdiCCt is reassuring. However, irregular cycles and prolonged menstrual periods were associated with a higher risk of patient-reported flare. The observation that fully adjusted baseline FC is lower in post- versus pre-menopausal women merits further exploration. Conflict of interest: Brito, Maria Teresa: No conflict of interest Dr. Constantine-Cooke, Nathan: No conflict of interest Ramos Belinchon, Clara: No conflict of interest Plevris, Nikolas: Speaker fees / travel support from Abbvie, Pfizer, Janssen, Lilly, Ferring Gros, Beatriz: Beatriz Gros has served as a speaker for Abbvie, Johnson and Johnson, Takeda, Roche, Gilead, Pfizer and Galapagos and has served as an advisor for Roche, Gilead, Abbvie, Galapagos and Takeda Bell, Sally: - Lees, Charlie: Consultancy and lecture fees: Abbvie, Oshi Health, Gilead, Pfizer, Takeda, Janssen, Shire, Samsung Bioepis, Dr Falk, GSK, Galapagos, Trellus Health, Iterative Scopes, Fresnius Kabi