Abstract Background Upadacitinib (UPA) is a reversible and selective Janus kinase inhibitor (JAK) and has been approved for the treatment of moderate to severe ulcerative colitis (UC). EUROPE is an ongoing, prospective, non-interventional, multicenter study of UPA in adult patients with moderate to severe UC in Germany, Austria and Switzerland (DACH). Methods The investigation of sex-specific differences is gaining increasing attention in research1. Here, we present data on patient-reported disease burden, stratified by sex, as measured with the IBD-Disk. Patients with both a documented visit at week 52 and ongoing treatment with UPA were included in this analysis. Safety data was available for 364 patients (≥1 dose of UPA). Results Baseline characteristics of the 159 included patients are shown in Table 1. At baseline (BL), women had a significant higher partial adapted Mayo Score (pAMS) and showed numerically higher levels of fecal calprotectin and C-reactive protein (CRP). While pancolitis was more frequent in men (62% vs. 39%), women predominantly had left-sided colitis (53% vs. 34% in men). BL steroid use was lower in women (34%) than men (48%). IBD-Disk total scores and scores for all individual dimensions of IBD-Disk were higher in women at BL. At week 8 and 52, IBD-Disk scores were comparable between women and men, thus decreasing more substantially in women. The most affected dimensions in women at BL were energy, sleep, abdominal pain and regulation of defecation, whereas in men, energy and sleep were most affected, followed by regulation of defecation and education and work (Figure 1). Mean values decreased in women and men up to week 8, with a greater reduction in women. By week 8, rates of symptomatic remission (stool frequency score 0/1 and rectal bleeding score = 0) for women vs. men were 70.3% and 74.2% (vs. 14.1% and 18.3% at BL), increasing to 87.5% and 81.7% by week 52, respectively. The influence of prognostic factors on IBD-Disk total score was analyzed. Sex and time since treatment initiation significantly affected the IBD-Disk total score. Furthermore, sex-stratification of this analysis indicated that, in men, BMI showed a significant effect on IBD-Disk total score, whereas in women, disease duration influenced these parameters. No new safety signals were detected. Conclusion We observed a higher disease burden across all dimensions of IBD-Disk in women compared to men. Disease burden improved substantially in response to UPA and was similar in women and men at week 8 and 52 of treatment. Further investigations are required to confirm the observed sex-dependent differences in symptom burden in independent cohorts. Reference: 1. Blumenstein I and Sonnenberg E (2023) Sex- and gender-related differences in inflammatory bowel diseases. Front. Gastroenterol. 2:1199687. Conflict of interest: Wiestler, Miriam: Financial compensation for lectures, advisory boards, other medical-scientific services by: AbbVie, Alfasigma, CED Service, Dr. Falk Pharma, FomF Forum für medizinische Fortbildung, FORUM Institut für Management GmbH, Johnson & Johnson, Lilly Deutschland GmbH, Pfizer, Takeda Pharma. No fees or payments were made for authorship. Schmelz, Renate: Renate Schmelz has received consulting fees and was on speaker bureaus for AbbVie Deutschland GmbH & Co KG, Alphasigma, Bristol Myers Squibb GmbH & Co KG, Celltrion Healthcare, Falk Foundation e.V, Johnson and Johnson, MSD Sharp & Dome GmbH, Lilly, Pharmacosmos, Pfizer, Takeda Pharma GmbH No fees or payments were made for authorship. Helwig, Ulf: Speaker/Consulting activity:AbbVie, Amgen, Biogen, BMS, Celltrion, Falk Foundation, Ferring, Janssen, Lilly, MSD, Mundipharma, Mylan Pharma, Pfizer, Sandoz, Shield, Takeda, Vifor, subsidy/fee: AbbVie, Amgen, Biogen, Celltrion, Falk Foundation, Ferring, Janssen, MSD, Mundipharma, Mylan Pharma, Pfizer, Sandoz, Shield, Takeda, Vifor Advisory board/committee: AbbVie, Amgen, Biogen, BMS, Celltrion, Janssen, MSD, Mundipharma, Mylan Pharma, Pfizer, Sandoz, Shield, Takeda, Vifor, No fees or payments were made for authorship. Moschen, Alexander R.: Personal fees from MSD, research support and personal fees from AbbVie, research support and personal fees from Takeda, personal fees from Janssen, grant support and personal fees from Pfizer, personal fees from Ferring, grants and personal fees from Amgen, personal fees from Dr Falk, personal fees from Novartis (Sandoz), personal fees from Nestlé, personal fees from Gebro Pharma, personal fees from Norgine, personal fees from Vifor, personal fees from Fresenius, personal fees from Astro Pharma, sidekick, endpoint health, UCB Pharma, High5Immunology. No fees or payments were made for authorship. Greuter, Thomas: Grant: Novartis Research Foundation Personal Fees: TG has consulting contracts with Sanofi-Regeneron, Janssen, BMS, Takeda, Abbvie and Falk Pharma GmbH, received travel grants from Falk Pharma GmbH and Vifor, speaker’s fee from Norgine No fees or payments were made for authorship. Fischer, Imma: I receive consultant fees from AbbVie Deutschland. The statistical analysis was supported by Dr. Imma Fischer, Biostatistics Tübingen, which was funded by AbbVie. Dr. Martin, Julia: Employee of AbbVie and may own shares or options in AbbVie AbbVie sponsored the study, contributed to the design, participated in collecting, analyzing, and interpreting the data, and preparing, reviewing, and approving the final version. The statistical analysis was supported by Dr. Imma Fischer, Biostatistics Tübingen, which was funded by AbbVie. No fees or payments were made for authorship. Rath, Stefan: Employees of AbbVie and may own shares or options in AbbVie. AbbVie sponsored the study, contributed to the design, participated in collecting, analyzing, and interpreting the data, and preparing, reviewing, and approving the final version. The statistical analysis was supported by Dr. Imma Fischer, Biostatistics Tübingen, which was funded by AbbVie. No fees or payments were made for authorship. Kucharzik, Torsten: Personal Fees: MSD, Abbvie, Amgen, Arena, Biogen, Boehringer, Bristol-Myers Squibb, Celgene, Celltrion, Falk Foundation, Ferring, Galapagos, Gilead, Janssen, J & J, Lilly, CED Service GmbH, Olympus, MSD, Mundipharma, Takeda, Pfizer, Roche, Vifor No fees or payments were made for authorship. Maaser, Christian: Speaker honaria and/or Advisory honaria Abbvie, Alfasigma, Biogen, Falk Foundation, Galapagos, Gilead, J & J, MSD Sharp & Dome, Pfizer, Roche, Samsung, Takeda No fees or payments were made for authorship. Zeissig, Sebastian: Grant: Ardeypharm, Celltrion Healthcare Personal Fees: Advisory: Abbvie Deutschland GmbH, Amgen GmbH, Biogen GmbH, Bristol-Myers Squibb GmbH, Celltrion Healthcare, Ferring Arzneimittel GmbH, Hogg Robinson GmbH, Mylan, Janssen Cilag GmbH, Pfizer Pharma GmbH, Takeda Pharma GmbH. Speakers bureau: Abbvie Deutschland GmbH, Amgen GmbH, Biogen GmbH, Bristol-Myers Squibb GmbH, CED Service GmbH, Falk Foundation e.V., Ferring Arzneimittel GmbH, FORGA Solutions GmbH, GWT-TUD GmbH, Janssen Cilag GmbH,,Janssen Pharmaceutica NV, MSD Sharp & Dome, Roche, Pfizer Pharma GmbH, Pharma Zentrale GmbH, Takeda Pharma GmbH, WebMD Global. No fees or payments were made for authorship.
Wiestler et al. (Thu,) studied this question.