Administering 2 biologics simultaneously, or a biologic in combination with a small molecule such as tofacitinib, should be among the options offered to patients with refractory IBD, said Robert Battat, MD, in his presentation at the Crohn’s & Colitis Congress on January 20.

Dr Battat, MD, is an assistant attending physician at NewYork-Presbyterian Hospital/Weill Cornell Medicine and Jill Roberts Center for Inflammatory Bowel Disease.

While these combination therapies do come with their own risk profiles, it is up to the physician and patient to decide whether the benefits outweigh those potential risks for those patients who have failed on other, conventional biologic treatments and are ineligible for clinical trials for any number of reasons

In an observational study, Battat and colleagues analyzed data from previously published literature on dual therapies for patients with inflammatory bowel diseases. This included 279 patients over 288 trials that ended as of 2021. A majority of the patients had Crohn disease, and a majority had failed multiple biologics (median number of biologics failed was 2, with some patients having failed up to 4).

In these trials, 31% of patients experienced adverse events, with 7% of those being serious. However, 59% of the patients experienced clinical remission, and 34% achieved endoscopic remission.

Dr Battat also explained the profile of the patient who should not be considered for dual therapy, which is essentially considered a last resort today because all data is observational. If a patient is naïve to a reasonable treatment option or eligible for a clinical trial, that established therapy/surgery or enrollment in the clinical trial should be attempted first. Additionally, patients who have comorbid illnesses, are immunosuppressed because of other immune-mediated disorders, or noncompliant, should not be considered. Dr Battat also noted that because most existing trials looked at patients with Crohn disease, and data for patients with ulcerative colitis is much more limited, this option may be better suited to patients with Crohn disease.

To choose therapies, physicians should have a complete medical history, so they can determine what therapies have already been tried with the patient, why those treatments failed, and whether there was proof of failure. If a patient has an extraintestinal manifestation (EIM), that can be considered by including a therapy that is efficacious for that EIM. Dr Battat also pointed out that there could be payor hurdles when it comes to dual therapies, and that it may require peer-to-peer insurance, a secondary insurance, or an alternative diagnosis for approval.

The caveat to this therapy option is that it is based only on observational data in 300 patients with inconsistent endpoints, resulting in loose recommendations and uncertainty in safety and efficacy profiles, as well as in cost-effectiveness. This information should all be shared with the patient when making decisions about dual therapies, explaining scientific rationale so that the patient can become a partner with the physician in the strategy.

However, these treatments are only recommended when a patient has had all other conventional means of treatment fail for them. While there is a need for more clinical trials, more data to confirm efficacy and safety, Dr Battat explained that dual therapies, in that scenario, could be “a way to help the patient sitting in front of me, today.”

—Allison Casey

Reference:

Battat R. Dual Biologic and Small Molecule Therapy. Presentation given at: Crohn’s & Colitis Congress 2022; January 20-22, 2022; Virtual.