Introduction

‘Biologic therapies’ are the mainstay treatment for moderate to severe Inflammatory Bowel Disease (IBD), resulting in fewer hospitalisations, adequate treatment response and mucosal healing. ^[1] Adalimumab, Golimumab, Ustekinumab & Risankizumab are administered subcutaneously (SC), Infliximab and Vedolizumab are administered intravenously (IV), and have additionally been available SC since 2020. SC Infliximab was used during the pandemic to limit exposure to hospitals & reduce risk of Covid-19, ^[2] as well as for convenience.

Aims & Methods

We explore patient’s views of IV and SC administered treatments via a paper-based survey for those patients who were on IV treatment when attending for infusions, and a telephone survey on patients with IBD who have been on SC treatment.

Results

IV survey

• 122 completed the survey.
• 50/122 (41.0%) were on Vedolizumab (41.0%), 64 (52.5%) Infliximab, 8 (6.6%) others / didn’t specify.
• 25/120 (20.8%) had been on IV therapy for 2-6 months, 17 (14.2%) for 7-12 months, 29 (24.2%) for 1-3 years, 21 (17.5%) for 3-5 years, 21 (17.5%) for >5 years.
• 107/120 (89.2%) rated treatments as easy, 13 (10.8%) intermediate, 0 difficult.
• 25/112 (22.3%) were previously on SC injections. Of this group: 15/24 (60.0%) favoured the IV route, 9 (36.0%) favoured the SC route.
• 4/15 who favoured the IV route “did not like to inject themselves” or “found it difficult”. 3/15 preferred IV route as they were being monitored.
• 104/110 (94.5%) attended all scheduled blood tests, 4 (3.6%) attended most of them
• 106/109 (97.2%) attended all OP appointments, 2 (1.8%) attend most
• 91/111 (82.0%) had no concerns, 10 (9.0%) had concerns over side effects (SE)
• 31/104 (29.8%) reported SE.
• 6/29 (20.7%) stated SE not affected their quality of life (QoL), 12 (41.4%) little impact QoL, 10 (34.5%) moderate impact, 1 (3.4%) severe impact.
• 96/105 (91.4%) would recommend IV route

• 106/113 (93.8%) completed the survey..
• 54/106 patients were on Adalimumab (50.9%), 24 (22.6%) Ustekinumab, 13 (12.2%) Vedolizumab , 13 (12.3%) Infliximab, 2 (1.9%) Golimumab
• 10/106 (9.4%) for 1-6 months, 21 (19.8%) for 6-12 months, 33 (31.1%) for 1-3yrs, 21 (19.8%) for 3-5 years and 20 (18.9%) for >5 years.
• 89/106 (83.9%) rated treatment administration as easy, 10 (9.4%) intermediate, 2 (1.9%) difficult
• 59/106 (55.7%) were previously on IV infusions. Of this group: 43/59 (72.9%) favoured the SC route, 8 (13.6%) favoured IV, and 8 (13.6%) no preference.
• 24/43 who favoured who favoured SC route stated ‘convenient”, “easy”, “not have to attend hospital” as reasons.
• 86/106 (81.1%) attended all scheduled blood tests, 5 (4.7%) attended most of them,
• 102/106 (96.2%) attended all OP appointments, 3 (2.8%) attend most,
• 68/106 (64.2%) had no concerns, 21 (19.81%) concerned about fewer face to face episodes
• 40/106 (37.7%) reported SE. 8 (20%) skin reactions
• 11/40 (27.5%) stated SE not affected their quality of life (QoL), 14 (35%) little impact QoL, 9 (22.5%) moderate impact, 6 (15%) severe impact.
• 87/106 (82.1%) recommend SC route

Conclusion

The survey found that both IV and SC treatments were easy to administer for the vast majority (89.2% & 84.9%), For patients on SC therapy who previously had IV infusions, 75.6% preferred SC as “convenient”, “easy” and “no (need to attend) hospital”. For patients on IV therapy who previously had SC, 60.0% preferred IV as “did not ned to self inject / found it difficult”, and “preferred monitoring”. Overall there are high levels of satisfaction with 91.4% of patients on IV treatment, and 82.1% of patients on SC treatment recommend their current route of administration.

References

1. E J Mao, G S Hazlewood, G G Kaplan, L Peyrin-Biroulet, and A N Ananthakrishnan, Systematic review with meta-analysis: comparative efficacy of immunosuppressants and biologics for reducing hospitalisation and surgery in Crohn's disease and ulcerative colitis. Aliment Pharmacol Ther, 45: 3-13. https://doi.org/10.1111/apt.13847
2. P J Smith, L Critchley, D Storey, et al, Efficacy and Safety of Elective Switching from Intravenous to Subcutaneous Infliximab [CT-P13]: A Multicentre Cohort Study, Journal of Crohn's and Colitis, Volume 16, Issue 9, September 2022, Pages 1436-46. https://doi.org/10.1093/ecco-jcc/jjac053

Introduction

In the southwest Netherlands, hospitals collaborate to provide high quality, uniform care for inflammatory bowel disease (IBD). To achieve this, a care pathway (CP) was implemented for treating IBD with biologics and small molecules (1). The CP consists of protocols addressing different stages in IBD treatment, such as initiation and switching of therapy, frequency and type of follow-up. This study assessed the adherence to the CP and identified barriers and facilitators to its implementation.

Aims & Methods

A mixed-methods study was conducted. Quantitative data was used to evaluate the adherence to different protocols of the CP and was collected retrospectively from electronic health records (EHRs) from December 2020 until March 2023. Surveys and semi-structured interviews were used to identify barriers and facilitators, using the Extended Normalisation Theory. Surveys were sent to all healthcare providers and interviews were conducted with gastroenterologists, IBD-nurses, healthcare assistants, and IT-personnel.

Results

A total of 299 patients were included. Adherence to the CP regarding the documentation of travel plans and vaccination status improved after implementing the CP (15% pre-implementation vs. 33% post-implementation), as well as written communication with general practitioners (31% vs. 83%) and body weight registration (12% vs. 50%). Among patients switching medication, 25% had a repeated screening for HIV, tuberculosis, and hepatitis B and C documented if prior tests were over a year old. Post-implementation, scheduling outpatient visits were more closely aligned with CP recommendations across CP protocols (57% vs. 100%), as did blood test ordering (10% vs. 44%). Disease activity scoring with validated questionnaires remained low (7% vs. 21%).  Adherence to registering medication adherence, current smoking status, and side effects during annual outpatient visits remained low (18% vs. 40%).
Of 85 surveys, 42 were completed, and 11 interviews were conducted. Facilitators were improving collaboration between healthcare providers and the potential to standardise care. Barriers included the complexity of the use in EHRs, difficulty for healthcare providers to change their current routine, and the heterogeneity of IBD.

Conclusion

A CP for the treatment of IBD with biologics and small molecules has been implemented to improve IBD care, however, adherence appears to be challenging, partially contributed to the difficulty healthcare providers experience in changing their behaviour. The gradual improvement indicates that increased familiarity with the CP may enhance adoption. Discrepancies between performed and documented tasks in EHRs may also contribute to lower adherence rates, which could be improved by audit and feedback sessions.

References

1. van Linschoten R, van Leeuwen N, Nieboer D, Birnie E, Scherpenzeel M, Verweij KE, et al. Value-based care pathway for inflammatory bowel disease: a protocol for the multicentre longitudinal non-randomised parallel cluster IBD Value study with baseline period. (2044-6055 (Electronic))

Disclosure

Drs. Visser received speaker fees from Lilly outside the submitted work. Prof. Dr. van der Woude reports grants from Pfizer and Janssen and personal fees from AbbVie and Celltrion outside the submitted work. Dr. van Noord reports personal fees from Janssen, Takeda, and Falk outside the submitted work. Dr. West reports personal fees from AbbVie, Janssen, and Pfizer outside the submitted work.