From July 2-3 and 8-10, 2021, the European Crohn’s and Colitis Organisation (ECCO) held its 2021 virtual Annual Congress (ECCO’21). During the Congress, many discussed new research and trends within the field of inflammatory bowel disease (IBD). According to Pharma Times, one presentation centered around post-hoc data from a Phase 3 clinical study evaluating filgotinib for patients with ulcerative colitis (UC). The data highlighted how filgotinib treatment improved UC-related symptoms, such as frequency of bowel movements. Interested in learning more? The data was also published in The Lancet.
To begin, what exactly is filgotinib? Filgotinib is an oral selective JAK1 inhibitor initially approved for the treatment of patients with rheumatoid arthritis (RA). According to drug developer Galapagos:
In more than 4,500 patient years of…clinical study experience, filgotinib has shown favorable results in terms of onset of action, efficacy, safety, and tolerability.
Within this particular Phase 3 study, researchers evaluated the safety, efficacy, and tolerability of filgotinib for patients with moderate-to-severe UC. During the trial, patients received either a placebo, 100mg filgotinib, or 200mg filgotinib. Patients previously treated with a JAK inhibitor were not included. Altogether, the primary endpoint included clinical remission and improvements in rectal bleeding or stool frequency (how often someone feels the need to, or does, pass a bowel movement). Findings included:
- There was no statistically significant difference between 100mg filgotinib and the placebo at week 10. However, by week 58, 100mg did show symptom improvement.
- Ultimately, the 200mg dose was the most effective. In fact, symptom relief appeared within the first few weeks of treatment. Additionally, this dose helped patients reduce or stop the use of corticosteroids.
- Altogether, patients who had previously been treated with biologics and those who had not experienced benefits from filgotinib therapy.
- While some adverse reactions did occur, the treatment was considered to be relatively safe and well-tolerated. Although two patients died during the course of the study, neither death was related to treatment.
Ulcerative Colitis (UC)
Ultimately, doctors are unsure of the exact cause of ulcerative colitis (UC), a chronic inflammatory disease causing sores and ulcers in the large intestine. However, some believe that UC could be related to immune dysfunction and triggered by elements such as stress or diet. UC exists under the umbrella of inflammatory bowel disease (IBD). Although UC symptoms can be debilitating or even life-threatening in later stages of the condition, many people with UC are unaware that they have it in early stages. Risk factors for developing UC include having Jewish ancestry, having a family history of IBD, or being under 30 or over 60 years old. Although this is not an exhaustive list of symptoms, potential symptoms include:
- Abdominal cramping and pain
- Unintended weight loss
- Persistent diarrhea
- Bloody stool
- Anemia (low red blood cell count)
- Severe dehydration
- Joint pain