Trial Outcomes & Findings for A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice (NCT NCT03532932)

Participants took part in the study at the 36 investigative sites in Russia, Belarus and Kazakhstan from 20 July 2018 to 08 November 2021.

Participants diagnosed with moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD) were observed retrospectively within 2 years before enrollment and prospectively one year after enrollment. A total of 1990 participants were enrolled (signed informed consent) into the study, of which 89 were screen failures. 1901 participants started the study and were analyzed in the study.

A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice

Treatment pattern with biologics agents or non-biological therapy included unique treatments combinations, Like\>5-ASA1(Start with 5-ASA:5-ASA→Systemic biologics \[SB\] +/- STER+/-standard therapy\[ST\]),\>5ASA2(without \[w/o\] STER),\>5ASA3(5-ASA→STER+/-ST),\>5ASA4(5-ASA→IS),\>5ASA 5(5-ASA→5-ASA+/-IS),\>5ASA6(5-ASA→ NOTR),\>5ASA7(5-ASA),\>NOTR1(NOTR→Biologics \[BIO\]+/-ST+/-STER),\>NOTR 2(TR→ST+/-STER),\>NOTR 3(NOTR),\>IS1(IS→SB+STER+/-ST),\>IS2(IS→SB+ST w/o STER),\>IS 3(IS→STER+/-ST),\>IS4(IS→5-ASA),\>IS5(IS→NOTR),\>IS6(IS→5-ASA+IS),\>IS7(IS mono),\>IS+5ASA1(IS+5-ASA→SB +/-ST),\>IS+5ASA2(IS+5-ASA→SB ±ST w/o STER),\>IS+5ASA3(IS+5-ASA→STER+/-ST),\>IS+5ASA4(IS+5-ASA→NOTR),\>IS+5ASA5(IS+5-ASA→IS),\>IS+5ASA6(IS+5-ASA→5-ASA),\>IS+5ASA7(IS+5-ASA),\>BIO1(SB+/-STER+/-ST→withdrawal \[w/d\] of SB+ST+/-STER),\>BIO2(SB+/-STER+/-ST),\>BIO3(SB+/-STER+/-ST→NOTR),\>BIO4(SB+/-STER+/-ST→SB mono),\>STER1(STER+/-ST→w/d of STER+SB+/-ST),\>STER2(STER+/-ST→w/d of STER+ST),\>STER3(STER+/-ST→SB+STER+/-ST),\>STER4(STER+/-ST→NOTR),\>STER5(STER+/-ST).

Disease Severity was defined using Harvey-Bradshaw Index (HBI) and mayo index. HBI is validated clinical index for evaluation of CD disease severity, including the 5 categories: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25, where score less than (\<) 5 was remission, score 5-7 was mild activity, score 8-16 was moderate, and score \>16 was severe. Mayo index was used for evaluation of UC disease severity. Mayo index is an instrument consisting of 4 categories of: stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment, each sub score graded from 0 to 3. The score ranges from 0 to 12, where score \<2 was remission, score 3-5 was mild, score 6-10 was moderate, and score \>10 was severe.

Disease activity assessment was performed using following methods- biomarkers, endoscopy, biopsy, X-ray, magnetic resonance imaging (MRI) and ultrasound examination. Number of participants whose disease activity was evaluated using the respective methods were reported.

Disease activity assessment was performed using following methods- biomarkers, endoscopy, biopsy, X-ray, MRI and ultrasound examination. Biomarkers was based on evaluation of C-reactive protein (CRP) and/or fecal calprotectin levels. Endoscopy included colonoscopy/rectoromanoscopy/sigmoidoscopy and/or video capsule endoscopy and/or esophagogastroduodenoscopy (in the presence or suspicion of the presence of lesions of the upper gastrointestinal tract in Crohn's disease), X-ray was used for examination of the intestine to exclude stricturing and other lesions, MRI was used for examination of the intestine to exclude stricturing and other lesions using MRI and ultrasound for examination of the intestine to exclude stricturing and other lesions. Number of assessments using different methods in participants with UC and CD disease activity was summarized for specified methods and reported in terms of mean and standard deviation.

The full Mayo index is an instrument to measure disease activity of UC. It consists of 4 parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score ranged from 0 (normal or inactive disease) to 3 (severe activity). The score ranged from 0 to 12, where score \<2 was remission, score 3-5 was mild activity, score 6-10 was moderate activity, and score \>10 was severe activity. Higher scores indicating higher disease activity.

HBI was used for evaluation of CD remission. It is a validated clinical index for CD, including the 5 categories of: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25, where score \<5 was remission, score 5-7 was mild activity, score 8-16 was moderate activity, and score \>16 was severe activity. Higher scores indicating higher disease activity.

Treat to target (T2T) approach was used for assessment of treatment goals. A "Treat to target" approach for UC included clinical remission (defined as resolution of rectal bleeding and diarrhea/altered bowel habit) and endoscopic remission (defined as Mayo endoscopic subscore of 0-1). Biomarker remission (normal C-reactive protein \[CRP\] and calprotectin) was considered as an adjunctive target. Histological remission was considered as an adjunctive goal. Clinical remission for CD was defined as resolution of abdominal pain and diarrhea/altered bowel habit. Endoscopic remission for CD was defined as resolution of ulceration at ileocolonoscopy or resolution of findings of inflammation on cross-sectional imaging in participants who cannot be adequately assessed with ileocolonoscopy. Biomarker remission (normal CRP and faecal calprotectin) was considered as an adjunctive target.

"Other" challenges included absence or inaccessibility of MRI (technical problems), participants financial difficulties, disability and bureaucratic problems, unavailability of biotherapy, limited quotas, referral of participants to other centers, absence of biotherapy treatment quotas, difficulty in performing computed tomography (CT).

Indications for surgical treatment included aggravation, intestinal bleeding, colon perforation, internal fistulas, abdominal cavity infiltrate, Interintestinal or Intraabdominal abscess, strictures in the gastrointestinal tract, anal fissures, and other. Types of surgeries includes both emergency and planned.