Work overview

Section 03 of 04

Results

Most of moderate to severe ulcerative colitis patients in academic clinical practice still do not qualify for randomized controlled trials

Sandra Elmasry, Shabana Pasha, Manreet Kaur, Jonathan A Leighton, Suryakanth R Gurudu, and Christina Ha · 2026

Contents

Section 03 of 04

  1. 01Introduction
  2. 02Methods
  3. 03Results
  4. 04Discussion
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Work overview

Section 3 of 4

Results

Sandra Elmasry, Shabana Pasha, Manreet Kaur, Jonathan A Leighton, Suryakanth R Gurudu, and Christina Ha · about 2 minutes

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A hundred and fifty patients with moderate to severe UC (defined as a total Mayo score ≥ 6) presenting for initial or change in medical treatment during the 32-month period were identified. Patients average age of 44.9 ± 18.5, 55.7% Men/44.3% Women with an average disease duration 11.6 yrs. ± 11.1 yrs. Disease extent of our patient population was: proctitis, 8.9%; left sided, 20.3%; and extensive disease, 70.8% (Table S1). There was no difference in age, gender, disease duration or extent between those who would qualify and those who would not qualify for an RCT. Overall, only 42.7% (n = 64) of patients would have qualified for at least one RCT. Among those, 11.3% for two trials, and another 11.3% for three or more trials.

Among the study population, the OCTAVE trial had the largest percentage of patients who would qualify (26.7%) while the LUCENT and ELEVATE trial had the least percentage of patients that would qualify (11.3%) (Table 1). The most common reason for trial ineligibility was current use or recent exposure to a medication as specified by the trial. Other more common exclusion factors included a history of colonic mucosal dysplasia or cancer excluded per trial definition, degree of anemia, prior medication exposure, active/recent infection, and disease extent. Figure 1 summarizes the distribution of these six exclusion factors overall and by individual trial. Percentages reflect the relative contribution of each factor among these six exclusion criteria, not the overall population or all exclusion reasons.

Figure 1: One large overall pie chart and seven smaller trial-specific pie charts compare the six most common exclusion factors across phase III ulcerative colitis trials. Overall, colon dysplasia was the leading exclusion factor (22.14%), followed by anemia (21.64%), prior use of an excluded medication (16.02%), current use of excluded medications (14.60%), abnormal liver enzymes (12.99%), and active Clostridioides difficile infection (12.62%). Colon dysplasia was the most common factor in TRUE NORTH, ELEVATE, OCTAVE, U-ACHIEVE/U-ACCOMPLISH, and UNIFI; active C. difficile infection was most common in LUCENT; and prior use of excluded medication was most common in VARSITY. Anemia and active C. difficile infection are identified as clinician-modifiable factors.

Figure 1: Top exclusion factors by each study and overall.

Table 1A: Trial eligibility for uc patients based on published inclusion/exclusion criteria
 | Qualify | Would not qualify
ANY Phase III UC RCT | 64 (42.7%) | 86 (57.3%)
VARSITY (adalimumab vs vedolizumab) | 19 (12.7%) | 131 (87.3%)
UNIFI (ustekinumab) | 33 (22.0%) | 117 (78.0%)
U-Accomplish & U-Achieve (upadacitinib) | 24 (16.0%) | 126 (84.0%)
OCTAVE (tofacitinib) | 40 (26.7%) | 110 (73.3%)
ELEVATE (etrasimod) | 17 (11.3%) | 133 (88.7%)
TRUE NORTH (ozanimod) | 29 (19.3%) | 121 (80.7%)
LUCENT (mirikizumab) | 17 (11.3%) | 133 (88.7%)