Implementation of an immunotherapy toxicity management clinic

Abstract

Objectives: Immune check-point inhibitors (ICIs) can have significant immune related adverse events (irAE) that may require high dose corticosteroids and inpatient management.1,2 This study investigated if a specialised clinic could reduce the total days of admission, time to taper steroids and improve detection of steroid complications in patients with select irAE needing systemic corticosteroids. The primary outcomes were time admitted and to taper steroids (<10 mg/day prednisone). Secondary outcomes were documented steroid complications, steroid sparing agent use and clinic completion.

Methods: An observational study at a tertiary centre in Queensland Australia was conducted. Data was collected prospectively for patients with select irAE requiring steroids managed in a specialist immunotherapy toxicity clinic and retrospectively prior to clinic implementation. The select toxicities were hepatitis, colitis, pneumonitis, nephritis, and dermatological. Patients were excluded if they did not require systemic steroids.

Results: Eighty-four patients who had selected irAEs and needed systems steroids were identified (44 prior to clinic and 40 managed in clinic). There was a numerical reduction in total days admitted with a mean of 3.23 days in the clinic group vs 8.07 in the non-clinic group (p = 0.108). The time taken to taper was also numerically lower at 48 days compared to 62 days (p = 0.881). There was a significant increase in the documentation of steroid side effects in the clinic patients at 60.5% vs 33.3% (p = 0.011). There was no difference in the rates of major steroid side effects.

Conclusion: The study was underpowered to comment on the significance of the difference of total admitted days but was numerically lower in the clinic managed group. There was a statistically significant increase in the documentation rates of steroid complications, thereby facilitating proactive management. The time to event curves were similar for time to taper steroids. Further study is needed to assess for financial benefit.