In the Journals

Home biologic infusions in IBD suffer from lack of monitoring

Patients with inflammatory bowel disease who received their biologic medication in home infusions rather than at a hospital experienced more adverse outcomes, according to research published in Clinical Gastroenterology and Hepatology.

Benjamin L. Cohen, MD, MAS, of The Susan and Leonard Feinstein IBD Center at the Icahn School of Medicine at Mount Sinai, and colleagues wrote that although some intravenous infusions of drugs like Remicade (infliximab, Janssen) and Entyvio (vedolizumab, Takeda) have started to transition into patients’ homes, there is no clear guidance or recommendations on the practice.

“Although [home infusion] of biologic medications is discouraged by the American College of Rheumatology, no clear guidelines exist in the gastroenterology literature,” they wrote.

Researchers conducted a matched retrospective cohort study of patients treated with infliximab or vedolizumab with home infusion (n = 69) compared with hospital infusion at a large, tertiary care IBD center. They matched home infusion patients with controls based on age, sex, IBD type, infusion medication and time on therapy prior to home infusion or matching.

The primary endpoint was a composite of adverse outcomes, including stopping biologic therapy, IBD-related emergency department visit or IBD-related hospitalization.

Investigators found that patients on home infusion were more likely to experience adverse outcomes compared with control patients (43.5% vs. 21.7%; P = .006), and they also had a shorter time to adverse outcomes than patients who got hospital infusions. Patients with home infusions trended toward stopping therapy within 1 year (20.3% vs. 8.7%; P = .053) and stopping therapy within the complete follow-up window (27.5% vs. 15.9%; P = .099) compared with controls. While they had more emergency department visits (30.4% vs. 7.2%, P < .001), they did not have significantly more hospitalizations (17.4% vs. 11.6%).

Cohen and colleagues wrote that the increase in adverse events might have been related to a reduced level of monitoring observed in home infusion patients. In the year following home infusion initiation or matching, patients who persisted on home infusions had significantly fewer IBD clinic visits (1.23 vs. 1.75; P = .018) compared with controls. They were also more likely to have two or fewer laboratory assessments in that first year compared with controls.

Although they see some benefit from home infusions, Cohen and colleagues wrote that more exploration is needed before they are common practice.

“Though [home infusion] may provide added convenience and possibly decrease costs for some patients, further research is needed to determine its safety, optimal patient selection and the true cost benefit,” they wrote. “Our data, the first of its kind, show an increase in [adverse outcomes] and therapy disruption with [adverse outcomes] and paves the way for larger, prospective studies to inform practice guidelines.”– by Alex Young

Disclosures: Cohen reports being on the advisory board or consulting for AbbVie, Alfasigma, Celltrion, Ferring, Grifols, Janssen, and Sublimity Therapeutics. Please see the full study for all other authors’ relevant financial disclosures.

Patients with inflammatory bowel disease who received their biologic medication in home infusions rather than at a hospital experienced more adverse outcomes, according to research published in Clinical Gastroenterology and Hepatology.

Benjamin L. Cohen, MD, MAS, of The Susan and Leonard Feinstein IBD Center at the Icahn School of Medicine at Mount Sinai, and colleagues wrote that although some intravenous infusions of drugs like Remicade (infliximab, Janssen) and Entyvio (vedolizumab, Takeda) have started to transition into patients’ homes, there is no clear guidance or recommendations on the practice.

“Although [home infusion] of biologic medications is discouraged by the American College of Rheumatology, no clear guidelines exist in the gastroenterology literature,” they wrote.

Researchers conducted a matched retrospective cohort study of patients treated with infliximab or vedolizumab with home infusion (n = 69) compared with hospital infusion at a large, tertiary care IBD center. They matched home infusion patients with controls based on age, sex, IBD type, infusion medication and time on therapy prior to home infusion or matching.

The primary endpoint was a composite of adverse outcomes, including stopping biologic therapy, IBD-related emergency department visit or IBD-related hospitalization.

Investigators found that patients on home infusion were more likely to experience adverse outcomes compared with control patients (43.5% vs. 21.7%; P = .006), and they also had a shorter time to adverse outcomes than patients who got hospital infusions. Patients with home infusions trended toward stopping therapy within 1 year (20.3% vs. 8.7%; P = .053) and stopping therapy within the complete follow-up window (27.5% vs. 15.9%; P = .099) compared with controls. While they had more emergency department visits (30.4% vs. 7.2%, P < .001), they did not have significantly more hospitalizations (17.4% vs. 11.6%).

Cohen and colleagues wrote that the increase in adverse events might have been related to a reduced level of monitoring observed in home infusion patients. In the year following home infusion initiation or matching, patients who persisted on home infusions had significantly fewer IBD clinic visits (1.23 vs. 1.75; P = .018) compared with controls. They were also more likely to have two or fewer laboratory assessments in that first year compared with controls.

Although they see some benefit from home infusions, Cohen and colleagues wrote that more exploration is needed before they are common practice.

“Though [home infusion] may provide added convenience and possibly decrease costs for some patients, further research is needed to determine its safety, optimal patient selection and the true cost benefit,” they wrote. “Our data, the first of its kind, show an increase in [adverse outcomes] and therapy disruption with [adverse outcomes] and paves the way for larger, prospective studies to inform practice guidelines.”– by Alex Young

Disclosures: Cohen reports being on the advisory board or consulting for AbbVie, Alfasigma, Celltrion, Ferring, Grifols, Janssen, and Sublimity Therapeutics. Please see the full study for all other authors’ relevant financial disclosures.