Short summary

A retrospective quality development project is investigating infusion reactions in patients with chronic inflammatory bowel disease (IBD) who are being treated with Infliximab (IFX) or Vedolizumab (VDZ). The study contributes to the quality assurance of current practice and future treatments by identifying infusion reactions and treatments og infusion reactions.

Rationale

Background

The prevalence of IBD in Denmark has been increasing over the past 30 years. The incidence is twice as high today as in 1980 The course of the disease is chronic with recurrent disease activity, and there is a need for regular examination and control at the hospital as well as specialized medical treatment. IBD is associated with significant morbidity, sickness leave, the need for surgery, increased health care costs and for subgroups an increased risk of colorectal cancer.

Biological drugs constitute the most effective medical treatments available today. The introduction of biological therapy has significantly increased the cost of treating IBD, and consumption has been increasing for several years. The Danish Medicines Agency recommends Infliximab as the first drug of choice for both ulcerative colitis and Crohn's disease [3]. Furthermore, the consumption of intravenous Vedolizumab is increasing. Together with an increasing prevalence of IBD in society, this leads to an increased need for staff and physical setting for infusion and observation, which constitutes a significant part of the cost of these treatments.

Patients with IBD and rheumatological disorders are observed for infusion reactions when administering IFX (indications: IBD, rheumatoid arthritis, spondylarthropathies, psoriatic arthritis) and VDZ (indication: IBD) based on the recommendations of the pharmaceutical companies. For both IFX and VDZ, there is 1 hour of observation after the first 3 infusions. When Ustekinumab was introduced, it was without a defined observation time after the first infusion, leading us to investigate whether it is possible to reduce the observation time for IFX and VZD, respectively.

In a retrospective study from 2018, over a 1-year period, 1152 infusions with IFX and 330 infusions with VDZ were analyzed with 953 subsequent observation hours [4]. A total of 10 infusion reactions (0.9%) occurred upon infusion with IFX, of which 6 (60%) occurred within the first 10 minutes. 2 infusion reactions (20%) occurred later during the infusion and 1 (10%) occurred 2 weeks after the infusion. No infusion reactions occurred during the observation period. No infusion reactions related to VDZ were seen; neither during infusion nor during the subsequent observation period.

Description of the cohort

The study includes patients with IBD (DK500-509, DK510-519, DK529A and DK523) who have received biological therapy with IFX (ML04AB02) or VDZ (ML04AA33

Data and biological material

Clinical background data will include: Gender, date of birth, diagnosis, year of diagnosis, previous medical treatment, previous surgery, smoking, extraintestinal manifestations, significant comorbidity including other autoimmune disorders, Charlson comorbidity index, height, weight by infusion reaction.

 Drug: Topical biologic drug, series, other concomitant immunosuppression (Azathioprine, 6-Mercaptopurine, Methotrexate).

 Infusions: Number of infusions during the study period, number of observation hours during the study period.

 Infusion reaction: Number of minutes after the start of the infusion, symptoms, objective findings, severity, medical treatment, clinical consequence (continued treatment +/- steroid, discontinuation, change to another drug).