How long does it take Entyvio to start working?

Entyvio may reduce your gut inflammation in about 6 weeks. Over time, Entyvio can help you to have fewer symptoms, go into remission, and reduce or stop the use of corticosteroids. In remission, your symptoms such as stomach pain and cramping, diarrhea and fatigue will go away.

Entyvio (generic name: vedolizumab) works by preventing too many white blood cells from entering into your GI tract (intestine). This helps to control inflammation and symptoms of ulcerative colitis and Crohn's disease.

Every patient reacts differently to medications and has a different level of disease severity, so your individual results may vary. Not every patient will respond to Entyvio. Your doctor can give you the best information about your treatment course.

If after 14 weeks you do not have a therapeutic benefit with Entyvio your doctor may decide to discontinue your treatment.

How well does Entyvio work for ulcerative colitis?

Entyvio may reduce your ulcerative colitis (UC) symptoms in about 6 weeks according to clinical trials, but symptoms improvement may occur sooner.

• Of 373 patients with UC who received intravenous (IV) Entyvio, 47% (225 patients) had a clinical response* at 6 weeks compared to 26% (149 patients) who received placebo (inactive agent).
• Some patients achieved clinical remission* at 6 weeks (17% on Entyvio vs. 5% on placebo), also a significant effect.
• In studies that were carried out to one year, 42% of patients were in clinical remission at Week 52 compared to 16% of patients on a placebo.

The Phase 3 VISIBLE 1 study assessed safety and efficacy of subcutaneous (SC) Enyvio at 52 weeks in patients with ulcerative colitis, after initial IV induction in 162 patients (56 placebo, 106 Entyvio). The SC dosage forms (108 mg/0.68 mL) include a single-dose pre-filled pen and a single-dose prefilled syringe.

• Patients must have achieved clinical response* at Week 6 to continue into the SC Ulcerative Colitis Trial.
• A statistically significant proportion of patients receiving Entyvio administered every 2 weeks achieved the primary endpoint of clinical remission* compared to patients receiving placebo (46% vs. 14%; p<0.001) at Week 52.
• Maintenance of remission* at Week 52 in the subgroup of patients who were in remission at Week 6, was 64% (16/25) in the Entyvio-treated group compared to 20% (3/15) in the placebo group.

*Clinical response was defined as a reduction in complete Mayo score of ≥3 points and ≥30% from baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. Clinical remission was defined as complete Mayo score of ≤2 points and no individual subscore >1 point.

Related questions

• How much does Entyvio cost per month?
• Is Entyvio an immunosuppressant or a biologic?
• Can I drink alcohol while taking Entyvio?

How well does Entyvio work for Crohn’s disease?

In patients with Crohn’s disease using IV Entyvio:

• 15% of those receiving Entyvio in 2 studies were in remission at 6 weeks, compared to 7% and 12% on placebo. Only one study was found to be statistically significant.
• In two intravenous (IV) Entyvio studies of 307 patients going out to one year, 39% of patients receiving Entyvio were in remission and 44% of patients had a clinical response, at the end of the trial, compared to 22% and 30% of patients who received a placebo, respectively. Both studies were found to be statistically significant.
• Clinical response was defined as a ≥100 decrease in CDAI from baseline. Clinical Remission was defined as CDAI ≤150.

In patients with moderate to severe Crohn's disease using the subcutaneous Enytvio injection:

• Efficacy for the subcutaneous (SC) injection formulation of Entyvio was compared to a placebo was assessed in the VISIBLE 2 Study in 409 patients with Crohn's disease.
• At week 6 after initial IV induction, patients were randomized to treatment or placebo every 2 weeks. Patients must have achieved a clinical response at Week 6 to continue into randomization.
• A significantly greater number of patients receiving Entyvio SC 108 mg maintenance injection administered every 2 weeks achieved long-term clinical remission compared to patients receiving placebo (48% vs. 34%; p<0.01) at Week 52. In VISIBLE 2, about half of of the patients treated with Entyvio SC achieved long-term clinical remission.
• Clinical remission is defined as CDAI score of ≤150 at Week 52.

This is not all the information you need to know about Entyvio (vedolizumab) for safe and effective use and does not take the place of your healthcare provider's directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.