Introduction

Crohn’s disease (CD) and ulcerative colitis (UC) are chronic and progressive inflammatory bowel diseases (IBD), frequently associated with bowel damage and extraintestinal manifestations, and present a significant burden for patients.

Aims & Methods

The IBD-PODCAST was a descriptive non-interventional, cross-sectional study, which aimed to estimate the proportion of patients with CD and UC with Suboptimal Disease Control (SDC) in a real-world setting, across 103 sites in 10 countries. Criteria for SDC were largely based on STRIDE-II¹ and modified by an expert panel. The original cohort consisted of 2185 IBD patients. We previously reported that treatment modification opportunities were possible in 49% of CD and 61% of UC patients on advanced therapy². The aim of this analysis was to evaluate treatment patterns and potential treatment modifications in patients on standard or escalated maintenance therapy with biologics according to summary of product characteristics (SmPC), at index date. Patients who were receiving induction phase regimen or concomitant multiple advanced therapies or were treated with lower dosages according to the label were excluded from this analysis. Patients whose therapy was escalated beyond SmPC indications (i.e., with shorter intervals of administration) were classified as “further escalated”.

Results

A total of 796 CD and 549 UC patients treated with biologics (infliximab, adalimumab, ustekinumab and vedolizumab) were analyzed. Results are summarized in Table 1. Overall, 52% CD and 47% UC patients were in SDC. Among patients treated with adalimumab standard biweekly dose, 50% CD and 37% UC patients had the potential to modify therapy, while 70% CD and 50% UC patients were still in SDC despite dose escalation; concerning patients further escalated with adalimumab, 60% CD and 75% UC were in SDC. Nearly half of the infliximab-treated-patients were still in SDC. In ustekinumab-treated group, 58% of CD patients treated every 12 weeks had SDC and were eligible for treatment modifications, while SDC was observed in 57% CD and 49% UC patients treated every 8 weeks and in 56% of CD and 82% of UC patients furtherly escalated. Among vedolizumab-treated patients, 42% CD and 39% UC patients with intravenous (IV) maintenance every 8 weeks were in SDC and candidates for treatment modification; SDC was observed also in 65% CD and 35% UC patients treated every 4 weeks with IV Vedolizumab. Table 1: treatment patterns in patients affected by UC and CD (total n = 1345)

Conclusion

This descriptive analysis showed suboptimally-controlled disease in nearly half of 1345 IBD patients treated with biologics. Moreover, almost half of patients whose therapy had already been escalated may still require treatment modification. These results further enhance the need for a targeted management strategy and additional therapeutic alternatives in IBD.

References

1. Turner D, et al.; International Organization for the Study of IBD. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021 Apr;160(5):1570-1583
2. D’Amico F , et al. Proportion of IBD patients with suboptimal control in daily clinical practice – Real-world evidence from the IBD-Podcast study. United European Gastroenterol J. 2024 (article in press).

Disclosure

This study was funded by AbbVie. No honoraria or payments were made for authorship. Fortrea, funded by AbbVie, oversaw data management, biostatistics, clinical study report, and medical writing. AbbVie reviewed and approved the publication. All authors had access to all relevant data and participated in data interpretation, writing, review, and approval of this abstract.
Ferdinando D’Amico served as a speaker for Sandoz, Takeda, Jannsen, Omega Pharma, and Galapagos and served as an advisory board member for Abbvie, Ferring, Galapagos, Jannsen, and Nestlé.
Fernando Gomollón has received honoraria as speaker from Janssen, AbbVie, Takeda, and MSD; and participated in advisory panels for Faes-Farma and AbbVie
Giorgos Bamias has received honoraria as an Advisor/Lecturer and/or research grants and/or clinical trial participant from Janssen, Pfizer, Takeda, Abbvie, MSD, Mylan, Genesis Pharma, Adacyte Therapeutics, Amgen, Ferring, Cooper, BMS, and Aenorasis.
Tobias Heatta-Speicher, Valentina Tornatore, Ricardo Prata and Lorenzo Gemignani are employees of AbbVie and may own stock/options.
Axel Dignass reports received fees for participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees from Abivax, AbbVie, Bristol Myers Squibb, Dr Falk Foundation, Galapagos, Gilead, Janssen, and Pfizer; consultancy fees from AbbVie, Amgen, Arena Pharmaceuticals, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Dr Falk Foundation, Ferring Pharmaceuticals, Fresenius Kabi, Galapagos, Janssen, Lilly, MSD, Pfizer, Pharmacosmos, Roche, Sandoz,; Stada, Takeda, Tillotts, and Vifor Pharma; payment for lectures including service on speakers bureaus from AbbVie, Biogen, CED Service GmbH, Celltrion, Falk Foundation, Ferring, Galapagos, Gilead, High5MD, Janssen, Materia Prima, MedToday, MSD, Pfizer, Sandoz, Takeda, Tillotts, and Vifor Pharma; payment for manuscript preparation from Abbvie, Falk Foundation, Janssen, Takeda, Thieme, and UniMed Verlag