# Prospective observational study of tofacitinib in ulcerative colitis – analysis of clinical data, fatigue and health-related quality of life during the induction phase

## TL;DR

This study shows that tofacitinib improves symptoms, quality of life, and fatigue in ulcerative colitis patients during the first 16 weeks of treatment in real-world settings.

## Contribution

The study provides new real-world evidence on the effectiveness of tofacitinib in ulcerative colitis during the induction phase.

## Key findings

- 49% of patients achieved a ≥50% reduction in fecal calprotectin by week 16.
- Quality of life improved significantly across all four Short Health Scale dimensions by week 16.
- Fatigue scores decreased by one-third from baseline to week 16.

## Abstract

Tofacitinib is a Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Prospective real-world data are scarce.

To collect data on clinical outcomes, including health-related quality of life (HRQoL) and fatigue during treatment with tofacitinib.

This is a prospective observational multicentre study in Sweden. In this analysis, outcomes at weeks 2, 8 and 16 are reported.

Patients with active UC confirmed with endoscopy or faecal calprotectin (FC) were enrolled during 2020–2023 when starting tofacitinib therapy.

In total, 103 patients were included. After 2 weeks of treatment, 50% (39/78) had achieved symptomatic response and at week 16, 39% (35/89) had achieved corticosteroid-free clinical remission according to the partial Mayo score. At week 16, a reduction in FC by ⩾50% was seen in 49% (35/71) and 24% (11/46) were in endoscopic remission. The frequency of arthralgia decreased from 29% (30/103) at baseline to 11% (10/89) at week 16. Regarding HRQoL at week 16; each of the four Short Health Scale dimensions (symptoms, social function, disease-related worry and general well-being) had improved by a median of 1 point (p < 0.01) and the European Quality of Life 5 Dimensions 5 Levels index improved from 0.80 to 0.87. Finally, the Inflammatory Bowel Disease Fatigue score measuring occurrence and severity showed an improvement with a decrease from 9 points at baseline to 6 at week 16 (p < 0.05).

Induction therapy with tofacitinib therapy was associated with improvements in patient-reported outcome measures of symptoms, endoscopic activity, arthralgia, HRQoL and fatigue. These real-world data illustrate that tofacitinib is a fast-acting drug with broad therapeutic effects in UC.

NCT04338204.

Graphical abstract

Tofacitinib treatment in ulcerative colitis; results
from treatment in the real world

What do we hope to find out? If patients with Ulcerative Colitis and treatment with tofacitinib improve in various expressions of their disease. Why was this research done? Ulcerative colitis is an inflammatory condition of the bowel that often affects a person’s life substantially with an impact on quality of life. Symptoms of the bowel such as diarrhea, blood in stool and urgency are limiting symptoms but fatigue and joint pain may also be present. Some of the symptoms may be independent to intestinal inflammation. Before approval, drugs must demonstrate effectiveness in intestinal inflammation in randomized trials, but treatment and results in a clinical reality may differ from these settings. What did we do? Patients with active ulcerative colitis suitable for tofacitinib treatment were included in the study. Information concerning bowel symptoms, laboratory tests, quality of life and fatigue were collected at inclusion, week 2, week 8 and week 16. For some patients, endoscopic data was available. Information at follow up were compared to data before treatment for the same patient. Established questionnaires were used to quantify and evaluate the patient reported parameters. What did we find out? From 16 hospitals in Sweden, 103 patients were included. During the first 16 week of treatment, patients improved in symptoms. At week 16, 4/10 patients were in clinical remission. Quality of life improved in all measured aspects. Occurrence and severity of fatigue decreased by 1/3. Patients reporting joint pain at inclusion decreased to 1/3 at week 16. Some improvements were seen already week 2. These results indicate broad effects of tofacitinib.