There are a variety of biologics approved to treat autoimmune diseases, such as psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s. Until now, the standard of care has only encompassed monotherapy. Patients will try and fail medications, hoping to find one that helps keep their disease symptoms under control.
However, for some patients, that disease control never comes. When patients have treatment resistant disease, or concomitant inflammatory conditions that cannot be controlled by one treatment alone— what’s next?
The answer for inflammatory bowel disease (IBD) might soon be: combination therapy.
When healthcare practitioners hear “combination therapy” they might immediately think of oncology, and rightfully so. There have not been any approved treatment protocols that combine immunology drugs to date, but that soon may change.
Johnson & Johnson conducted a phase 2a, proof-of-concept study (VEGA) of 214 patients with moderate to severe ulcerative colitis (UC), which pointed to higher remission rates in patients receiving guselkumab and golimumab compared to monotherapy cohorts. It was the first study to show the possibility of increased efficacy and comparable safety for dual therapy. Johnson & Johnson is now conducting a phase 2b randomized, double-blind, multicenter study (DUET-UC) to evaluate the efficacy and safety of subcutaneous guselkumab and subcutaneous golimumab combination therapy vs TREMFYA or golimumab monotherapy in adult patients with moderate to severe active UC.1
Johnson & Johnson is not without competition. AbbVie has studied risankizumab and upadacitinib combination therapy in refractory Crohn’s disease (CD). Patients in these studies have “medically complex” disease and have tried a median of 5 therapies. Risankizumab and upadacitinib were associated with a clinical remission rate of 71.4%, with some patients even achieving clinical remission. This type of efficacy is considered “breakthrough,” and the treatment was well-tolerated with minimal discontinuation due to adverse events. Even though these patients had prior biologic failure and surgical history, they still showed high remission and response rates, which encourages the further study of this type of treatment approach.2
Eli Lilly is also conducting similar studies, specifically investigating Omvoh in combination with other treatments, to see if breakthrough efficacy can be achieved in UC.
These include studies in UC with eltrekibart, a monoclonal antibody that targets neutrophil-driven inflammation, and with LY4268989 (MORF-057), an oral α4β7 integrin inhibitor. Omvoh is currently indicated for moderate to severe CD and moderate to severe UC.3
As these studies continue with promising results, it begs the question: what are the pros and cons of combination therapy in IBD? And how will solid data change the market? The U.S. inflammatory bowel disease treatment market size was estimated to be $13.12 billion in 2024, and is only projected to grow.4
There are inherent risks in this treatment approach, in that these treatments are often lifelong. This creates an obstacle for patients, who risk long term side effects not limited to organ damage, metabolic complications, and cardiovascular risks. Careful monitoring is essential, as incorrect doses can lead to under- or over-suppression of the immune system, which can worsen disease activity or increase the occurrence of infections.5
The potential risk underscores the need for proven data in clinical trials to demonstrate the efficacy and safety of combination therapies in IBD. Without this data, payers will not consider this treatment option viable, even for patients who have tried and failed multiple therapies. In an article published by Healio Rheumatology, Dr. Philip Mease director of rheumatology research at Swedish Medical Center/Providence-St. Joseph Health stated that dual therapy can “prompt access challenges” and that the most successful tactic they have seen for securing insurance coverage is if “rheumatologists prescribe one medication and gastroenterologists or dermatologists prescribe the other.”6
Given the data thus far, it makes sense for clinicians to wonder if the immunology space should seriously consider combination therapies, not dissimilar to the standard of care in oncology. With time and continued research, the data may change the treatment landscape in a dramatic way.
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