The incidence of remission and indicators of inadequate response to advanced therapy in patients with ulcerative colitis: results from medical charts in the United Kingdom

Abstract

Objective

A considerable proportion of patients with moderate-to-severe ulcerative colitis (UC) treated with advanced therapies do not achieve remission, even after 1 year of treatment, and suboptimal response to advanced therapies is frequently observed in clinical practice. This study aimed to analyze clinical practice data in the United Kingdom (UK) and assess the rates of clinical remission and inadequate response with advanced therapies among patients with UC.

Methods

This retrospective chart review included patients with UC who initiated a new advanced therapy (i.e. adalimumab, infliximab, golimumab, tofacitinib, or vedolizumab) between January 2017 and September 2019 from eight clinics across the UK. At least 12 months of data before and after starting an advanced therapy were required. Remission was assessed using components of the Mayo score. Inadequate response was defined by therapeutic adjustment or emergency treatment.

Results

Among 238 patients included (female: 46.6%; median age: 42.0 years; median follow-up: 28.8 months), 178 patients (74.8%) were biologic-naïve. At 12 months, 87 patients (53.9%) had achieved remission (median time to remission: 7.6 months), although 29 (33.3%) among them had required therapeutic modifications to achieve remission. At 12 months, 105 patients (44.3%) had at least one indicator of an inadequate response (median time to the first indicator of inadequate response: 18.0 months).

Conclusions

Nearly half of the patients did not achieve remission, and almost half of the included patients had an inadequate response within 1 year after treatment initiation. More effective therapies are needed to effectively treat UC.

PLAIN LANGUAGE SUMMARY

Treatment of ulcerative colitis (UC) follows a stepwise approach that considers disease severity and disease activity. It has the goal of achieving and maintaining steroid-free remission and healing of the gut lining. Treatment options for UC include several conventional and advanced therapies. However, suboptimal response to treatment has been reported in previous observational studies. This results in treatment adjustments, such as therapy discontinuation, dose intensification, and addition of conventional therapies, as well as lengthy concurrent use of corticosteroids.

This retrospective chart review evaluated clinical practice data from eight clinics across the United Kingdom. This was done to assess rates of clinical remission and indicators of suboptimal response to advanced therapies among patients with UC. The analysis included data from January 2017 to September 2019.

Nearly half of the patients did not have clinical remission within 1 year after starting advanced therapies. Optimization of advanced therapies was often seen, even in patients in remission. The most common indicators of suboptimal therapy were therapy discontinuation, dose escalation of advanced therapy, and the addition of conventional therapies. Our findings suggest that the efficacy of advanced therapies to treat UC remains insufficient in clinical practice. Thus, there is a need for more effective treatment alternatives to achieve better outcomes for patients with UC.

Keywords:

• Ulcerative colitis
• biologics
• Janus kinase inhibitors
• drug therapy
• multicenter study
• inflammatory bowel diseases

Transparency

Declaration of funding

This study was funded by Galapagos NV (Mechelen, Belgium).

Declaration of financial/other relationships

James O. Lindsay has served as a consultant and an advisory board participant for AbbVie, Allergan (Warner Chilcott), Atlantic Healthcare, Bristol Myers Squibb, Celgene, Celltrion, Ferring Pharmaceuticals, Galapagos, Gilead, GSK, Janssen, Lilly, MSD, Napp, Pfizer, Shire, Takeda, and Vifor Pharma; has received speaker fees and sponsorship for academic meetings from AbbVie, Allergan (Warner Chilcott), Ferring Pharmaceuticals, Janssen, MSD, Napp, Norgine, Pfizer, Shire, Takeda, and Tillotts Pharma; and has received investigator-led research grants from AbbVie, Gilead, Pfizer, Shire, and Takeda. Nils Picker and Daniel Kromer are employees of Ingress-Health; the work of Ingress-Health in this study was funded by Galapagos NV. Michael Smyth is a former employee of Galapagos UK. Haridarshan Patel is a former employee of Galapagos NV. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

James O. Lindsay contributed to the acquisition of data analyzed in this study. Nils Picker and Daniel Kromer performed the statistical analyses. All authors made substantial contributions to the conception and design, as well as the interpretation of data, and were involved in drafting this manuscript. All authors approved the final version of the manuscript. Haridarshan Patel is the guarantor of the article.

Acknowledgements

The medical writing support was provided by Daniel Kromer, PhD (Ingress-Health, Wismar, Germany) and editorial and publications management support was provided by PharmaGenesis London, London, UK, both funded by Galapagos NV. Publication coordination support was provided by Ornah Levine-Dolberg of Galapagos NV. The authors thank the participating study sites that provided data for this study. The data collection for this research was supported by Joya Bhattacharyya (Bedfordshire Hospitals NHS Foundation Trust), Htar Htar Hlaing (West Suffolk NHS Foundation Trust), Ruth Penn (Buckinghamshire Healthcare NHS Trust), Richard Shenderey (Airedale NHS Foundation Trust), Vivek Goel (Aneurin Bevan Local Health Board), Monira Rahman (Surrey and Sussex Healthcare NHS Trust), Melissa Smith (Brighton and Sussex University Hospitals NHS Foundation Trust) and James O. Lindsay (Barts Health NHS Trust).

Data availability statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.