P274 Drug utilization of biologic therapy in Crohn’s disease and ulcerative colitis: A population based Danish cohort study 2015-2018

Jensen, K.(1);Jensen, C.B.(1);Wennerström, C.(2);Sommer, K.J.(3);Burisch, J.(4);Petersen, J.(1);

(1)Center for Clinical Research and Prevention- Frederiksberg Hospital, Copenhagen Phase IV Unit Phase4Cph, Frederiksberg, Denmark;(2)Janssen Cilag AB, Nordic Medical Operations, Solna, Sweden;(3)Janssen-Cilag A/S, Medical Affairs, Birkerød, Denmark;(4)Hvidovre Hospital, Gastrounit- Medical Division, Hvidovre, Denmark

Background

For patients with Crohn’s disease (CD) and Ulcerative Colitis (UC) that are not adequately responding to systemic immunosuppressants, or are intolerant to conventional therapies, several biologic treatments have become available. The aim of the present study was to characterize the drug utilization and switch patterns of the biologics in respect to treatment line.

Methods

Using Danish national registries, the nation-wide study included individuals diagnosed with UC or CD who were biologic-naïve when initiating treatment with Infliximab (IFX), Adalimumab (ADA), Vedolizumab (VDZ), Golimumab (GOL), or Ustekinumab (UST) during years 2015-2018. The hazard ratios (HR) of switching or discontinuing from first treatment were explored using Cox regression adjusted for health-related and socio-economic parameters at treatment initiation. A therapy switch was defined as the administration of a biologic therapy different from the current within 90 days from last biologic dispensing period.

Results

Among 1,836 CD patients and 1,886 UC patients, IFX was used as first line biologic treatment in 91% (1,667) of CD patients and 92% (1,740) of UC patients. This was followed by ADA with 7% (129), VDZ with 2% (35) and UST with 0.2% (5) for CD patients, and ADA with 5% (88), VDZ with 2% (34) and GOL with 1% (24) for the UC patients, (figure 1).

In total, 18% (338) of CD patients and 24% (451) of UC patients switched biologic during the study period. Among CD patients with IFX as first-line treatment, 12% (207/1667) switched to ADA, whereas 6% (96/1667) switched to VDZ. UC patients with IFX as first-line treatment, 6% (105/1740) switched to ADA, and 12% (201/1740) to VDZ. When administered ADA as first-line treatment, 11% (14/129) shifted to IFX in the CD patients, and 17% (15/88) shifted to IFX in the UC patients. Overall, 6% (111) of CD patients and 9% (163) of UC patients experienced ≥2 therapy switches during the study period.

Comparing ADA to IFX as first-line treatment, there was a higher risk of discontinuation of treatment among CD patients (HR: 2.25 (95% confidence interval: 1.71; 2.97)) and in UC patients (1.93 (1.42; 2.63)), whereas no difference in risk of switch to another biologic treatment was observed. In both CD and UC patients, analyses of VDZ, GOL, and UST as first-line were impaired due to few events.

Conclusion

More than 90% of CD and UC patients initiating biologic therapy had IFX as their first-line biologic treatment, which is recommended by the official treatment guidelines. The reason for deviation from treatment guidelines or switch in therapy should be explored in further studies as well as the higher incidence of treatment discontinuation for ADA as first-line treatment.