AJG: Filgotinib treatment of ulcerative colitis can quickly induce symptom relief

Ulcerative colitis (UC) is a chronic and debilitating colon disease characterized by inflammation and ulceration of the mucous membranes, as well as symptoms of rectal bleeding and diarrhea
.
Short-term treatment goals for patients with UC include achieving clinical remission and reducing inflammation, and long-term goals include improving health-related quality of life (HRQoL) and achieving long-term corticosteroid-free remission
.
While endoscopy provides an objective assessment of disease activity and is essential for disease diagnosis, it is an invasive procedure
.

In contrast, patient-reported outcomes (PROs), including rectal bleeding and frequency of bowel movements assessed using patient diary data, were more frequently used
clinically.
Importantly, normalization of rectal bleeding and stool frequency is associated with
endoscopic improvement.
Filgotinib is a once-daily oral Janus kinase 1 inhibitor used to treat a variety of inflammatory diseases
.

This study aimed to assess the association
between early symptom improvement and health-related quality of life (HRQoL) outcomes and Filgotinib use.

The investigators conducted a double-blind, randomized, placebo-controlled 58-week SELECTION trial in which rectal bleeding and stool frequency on days 1-15 were recorded in post-hoc analysis and partial Mayo Clinic scores (pMCS)
were recorded at multiple time points including weeks 10 and 10.
HRQoL
was assessed using the Inflammatory Bowel Disease Questionnaire at weeks 10 and 58.

Compared to placebo, Filgotinib 200 mg improved rectal bleeding and bowel movements (P<0.
05) over 7 days
.
By week 2, patients treated with filgotinib 200 mg achieved remission of pMCS at a higher rate than those treated with placebo (15.
1% vs.
8.
0%, P=0.
0410 in patients who did not receive biotherapy; 10.
3% vs 4.
2%, P=0.
0274 in patients treated with biotherapy).

A similar therapeutic effect was observed at week 58 (P<0.
0001).

Rectal bleeding and stool frequency subscores on day 7 correlated with
Mayo Clinic score responses at weeks 10 and 58.
Patients who responded to pMCS at weeks 10 and 58 had greater
improvement in inflammatory bowel disease questionnaire scores compared with those who did not achieve pMCS remission.

This study confirmed that 200 mg of Filgotinib per day can lead to rapid and sustained improvement
in UC symptoms and HRQoL.

Original source:

Danese, Silvio.
et al.
Rapid and Sustained Symptom Relief in Patients With Ulcerative Colitis Treated With Filgotinib: Data From the Phase 2b/3 SELECTION Trial.
American Journal of Gastroenterology.
2022.