This is because of the well-documented, excellent safety profiles of those two biologics, which are particularly relevant in an elderly population at increased background risk for lymphoma and serious infections. A pooled analysis of three clinical trials of ustekinumab in induction therapy for Crohn’s disease showed an adverse event risk no different from placebo (J Comp Eff Res. 2017 Oct;6[7]:601-12). Vedolizumab, like ustekinumab, doesn’t carry a black box warning for lymphoma, and the biologic had no increase in any infections in an analysis of six clinical trials entailing more than 4,800 person-years of vedolizumab exposure (Gut. 2017 May;66[5]:839-51).
She provided three illustrative clinical scenarios, each involving a 62-year-old fit and active patient. If that patient had newly diagnosed moderate to severe ulcerative colitis, had failed on 5-aminosalicylic acid, and had good symptomatic control on prednisone, that’s someone who needs a steroid-sparing drug, and she would choose vedolizumab based upon its track record. If that active 62-year-old had moderate to severe ileal and perianal Crohn’s disease, she would opt for ustekinumab or a tumor necrosis factor inhibitor. But if that older patient was hospitalized with newly diagnosed severe ulcerative colitis that was only partially responsive to intravenous steroids, she would eschew vedolizumab and ustekinumab and turn to infliximab (Remicade).
“That patient should get infliximab just like a 32-year-old would. You need to give this patient the best shot [at avoiding colectomy], and to this day the data still supports infliximab in that population,” Dr. Mahadevan said.
Complicating management in the elderly are the commonly encountered challenges posed by polypharmacy, frailty, history of skin cancer or solid organ tumors, and heart failure. In one study, older patients with Crohn’s disease were on an average of 10 medications, ulcerative colitis patients on nine. Forty percent of the patients had potential drug-drug interactions involving their IBD medications (Inflamm Bowel Dis. 2015 Jun;21[6]:1392-400). These are situations that require individually tailored immunosuppressive decision-making.
Dr. Mahadevan reported receiving research support from the Crohn’s and Colitis Foundation, Celgene, and Pfizer and serving as a consultant to those pharmaceutical companies as well as AbbVie, Janssen, and Takeda.