Vedolizumab Is Safe and Effective in Elderly Patients with Inflammatory Bowel Disease
Vedolizumab (VDZ) is a gut-selective monoclonal antibody that inhibits the interaction of α4β7 integrin found in the lymphocyte surface with the addressing cell adhesion molecule (MAdCAM-1) present in the intestinal endothelium, thereby preventing the recruitment of lymphocytes into the inflamed tissue.1,2 The safety and efficacy of biological agents, such as anti–tumor necrosis factors, in elderly patients have been studied.3 Similar information is not available for VDZ. We studied the efficacy and safety of VDZ in elderly patients (>60 years old) with ulcerative colitis (UC) and Crohn’s disease (CD).
All adult patients with inflammatory bowel disease initiated on VDZ through the Florida hospital Inflammatory Bowel Disease Center and University of Florida Gainesville from August 2014 until December 2015 were eligible for enrollment. At weeks 14 and 52 and up to the time of the last follow-up, assessment of disease activity for patients with CD was performed using the Harvey–Bradshaw index. For patients with UC, the partial Mayo score, a simplified 9-point version of the Mayo score (remission defined as ≤2 and no subscore >1), was calculated. Adverse events were graded as serious if they resulted in discontinuation of VDZ, hospitalization, or death. Infections were graded as serious if they required antibiotics or they resulted in discontinuation of VDZ, hospitalization, or death. The efficacy and safety outcomes were described quantitatively.
We identified a total of 29 patients (41.4% men) with inflammatory bowel disease (10 UC and 19 CD) who initiated VDZ therapy over the age of 60 years (mean 67.1 ± 5.3 years). Among the 10 patients with UC, extensive colitis was seen in 8 (80%) and left-sided colitis was seen in 2 (20%) patients. Among the 19 patients with CD, 15 (78.9%) had colonic involvement with or without ileal involvement, whereas 4 (21.1%) patients only had ileal involvement. Previous anti–tumor necrosis factor therapy was used in 20/29 patients (68.9%). The remaining 9 patients (31.1%) were anti–tumor necrosis factor naïve. The median clinical follow-up was for 30 weeks (25–56). Clinical remission and clinical response are listed in Table 1. Cumulative rates of progression to surgery after 12 months of maintenance therapy were 10.3%: total proctocolectomy with end ileostomy for refractory disease (n = 2) and ileocolonic resection for persistent disease activity (n = 1). There were no infusion reactions. Four patients (13.8%) experienced adverse reactions, including pneumonia in 1 patient with UC, Clostridium difficile in 1 patient with CD, and flu-like symptoms (musculoskeletal syndrome was characterized by diffuse myalgias and arthralgias, requiring discontinuation of therapy). VDZ was discontinued in 3 patients. To conclude, our study reports the safety and efficacy of VDZ in elderly population in a real-world experience.