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Increased Frequency of Vedolizumab Helped Non-Responders
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ORLANDO, Fla. — A higher percentage of patients with inflammatory bowel disease who lost response to vedolizumab achieved clinical remission and response after vedolizumab dosing frequency was increased, according to data presented here.
"Some patients who lose response on every 8 week maintenance dosing with vedolizumab regain response or remission when the dosing interval is reduced to every 4 weeks," Bruce E. Sands, MD, MS, from the Icahn School of Medicine at Mount Sinai, told Healio Gastroenterology. "In addition, the rates of re-capture appear to be similar to initial induction rates."
In a 52-week open-label extension study (GEMINI LTS), Sands and colleagues aimed to determine the effects of increasing dosing frequency of vedolizumab (Entyvio, Takeda Pharmaceuticals) to every 4 weeks in IBD patients who had lost response to 300 mg vedolizumab every 8 weeks during the GEMINI 1 (n=32; ulcerative colitis) or 2 (n=57; Crohn’s disease) trials.
Bruce E. Sands
They found that percentages of patients with clinical remission and response increased after the increase in dosing frequency, and the increased rates were “generally maintained” throughout the study period. Among patients from the GEMINI 1 cohort, 6.3% were in clinical remission at baseline, which increased to 25% by week 28 through week 52; clinical response was achieved by 18.8% at baseline, which increased to 53.1% in week 28 but dropped to 37.5% at week 52. Among patients from the GEMINI 2 cohort, 3.5% were in remission at baseline, which increased to 22.8% at week 28 and 31.6% at week 52; clinical response was achieved by 38.6% at baseline, which increased to 54.4% at week 28 but dropped to 47.4% at week 52.
By the end of the study period, median predicted average vedolizumab concentrations were slightly higher in patients who completed the GEMINI 1 (36.9 mcg/mL) and 2 (39.5 mcg/mL) trials compared with those who discontinued due to lack of efficacy and enrolled in GEMINI LTS (30.5 mcg/mL and 32.7 mcg/mL, respectively). Adverse event profiles were similar between dosing frequency regimens.
“Percentages of clinical remission and response increased after [vedolizumab] dosing frequency was increased to [every 4 weeks] for patients with UC or CD who had lost response to [vedolizumab every 8 weeks],” the researchers concluded. “Average [vedolizumab] concentrations at week 52 were predicted to be only slightly lower in these patients than in patients treated with [vedolizumab every 8 weeks] who completed GEMINI 1 or 2."
"These data provide a possible strategy for patients who lose response on maintenance dosing with vedolizumab," Sands said.
For more information:
Sands BE. P-098. Presented at: 2014 Advances in Inflammatory Bowel Diseases, Dec. 4-6, 2014; Orlando, Fla.
Disclosure: The researchers report numerous financial disclosures including financial ties with Takeda Pharmaceuticals.