How effective are biologics for ulcerative colitis?

In clinical trials, all of the biologic drugs approved to treat moderate to severe ulcerative colitis (UC) have been shown to be effective at decreasing symptoms (inducing remission) and preventing a return of symptoms (maintaining remission) when compared to a placebo.

Biologic drugs approved for UC include:

• Adalimumab (Humira and Amjevita, among others)
• Infliximab (Remicade and Remsima, among others)
• Vedolizumab (Entyvio)
• Ustekinumab (Stelara)
• Golimumab (Simponi)

Several biosimilars, or biologics that are similar to the originals and used to treat patients, are also approved and available.

Biologics are an option when other, more standard therapies have failed to help, which occurs in about 20 to 40% of patients.

Biologics may help achieve remission

Data from clinical studies suggest that between 30 and 65% of ulcerative colitis patients will achieve remission (the absence of symptoms and inflammation) after taking a biologic medication for one year.

However, the rate of responders versus non-responders varies depending on the biologic. Doctors may refer to patients who benefit from biologic drugs as “responders,” while “non-responders” are those who don’t see improvements.

For example, in a study in Crohn’s & Colitis of 134 adults with ulcerative colitis, researchers found that:

• 56.9% of those who took adalimumab were responders
• 62.5% of those who took infliximab were responders
• 47.5% of those who took vedolizumab were responders

Below are some examples of the biologics used to treat ulcerative colitis and their effectiveness in clinical trials as reported to the Food and Drug Administration (FDA).

Adalimumab (Humira)
In a clinical trial, 17.3% of those treated with adalimumab achieved remission after one year, compared to 8.5% of those who did not take adalimumab.

Vedolizumab (Entyvio)
In a clinical trial, 42% of those treated with vedolizumab achieved remission after one year, compared to 16% of those who did not take vedolizumab.

Infliximab (Remicade)
In a clinical trial, 35% of those treated with infliximab achieved remission after one year, compared to 17% of those who did not take infliximab.

Ustekinumab (STELARA)
In a clinical trial, 45% of those treated with ustekinumab achieved remission after one year, compared to 26% of those who did not take ustekinumab.

Related questions

• What can I eat or drink with ulcerative colitis?
• Which is worse: Ulcerative colitis or Crohn's disease?
• How long do ulcerative colitis flare-ups last?

Biologics may lower the need for surgery

Biologics can help protect some patients with moderate to severe ulcerative colitis from requiring surgery or hospitalization. The percentage of people with ulcerative colitis receiving biologic drugs has increased substantially since 1998, when infliximab became the first FDA-approved biologic. Now, about 16% of the patient population is estimated to use biologics.

According to a 2020 study in Inflammatory Bowel Disease of more than 500 patients with UC, the introduction and utilization of biologics may be responsible for a marked decline in the number of patients who need to undergo surgery.

In the pre-biologics era, about 20% of patients with ulcerative colitis needed a colectomy (surgery to remove the colon) during their first hospitalization, and 30% required a colectomy within a year of their first hospitalization.
Since the introduction of biologics, those rates have declined to 5.3 and 11.9%, respectively, providing potential evidence that biologics have spared many patients from losing their colons.

Response is individual

However, not all patients with ulcerative colitis experience improvements while taking biologics. Some patients see no benefits at all. For others, the drugs provide benefits but do not bring about remission, or their effectiveness wanes over time, resulting in a relapse of symptoms. Some people who take biologics for UC may still go on to need surgery.