← Issue №9/ week of Aug 30, 2026/IBD

Clinical Outcomes After Ustekinumab Biosimilar Switching in Crohn's Disease: the USBIOS IG-IBD Study.

From GI Signals issue №9: what this paper found, what it changes, and where it sits against the current standard of care, reviewed by Simon Mathews, MD.

IBD prospective cohort · n=462 · Aug 27, 2026 · Clin Gastro Hep · IF 16.2

Clinical Outcomes After Ustekinumab Biosimilar Switching in Crohn's Disease: the USBIOS IG-IBD Study.

New evidenceCrohn's diseasebiologicsustekinumabhealth services
Clinical takeawayConsider switching clinically stable Crohn's disease patients on ustekinumab to biosimilars when procurement-driven, as effectiveness and safety appear comparable at 6 months.
What it foundSwitching to ustekinumab biosimilars in Crohn's disease patients in remission showed 92.2% expanded clinical success vs 92.7% with continued reference treatment (risk difference -0.5%, 95% CI -5.9 to 4.9), meeting noninferiority within a 15% margin.
ContextConfirms biosimilar noninferiority in a real-world setting, addressing a gap in controlled evidence for ustekinumab biosimilar switching in Crohn's disease.
Reinforcessuggested applicable standard· American College of Gastroenterology, 'ACG Clinical Guideline: Management of Crohn’s Disease in Adults' (Lichtenstein GR, Loftus EV, Afzali A, et al., Am J Gastroenterol 2025;120(6):1225-1264). DOI 10.14309/ajg.0000000000003465, PMID 40701562.

Decision at stakethe use of ustekinumab for induction and maintenance in Crohn's disease

MILD-TO-MODERATE / LOWER PROGRESSION RISK: Recommend AGAINST oral mesalamine for induction or maintenance (strong, moderate); sulfasalazine should be considered ONLY for symptomatic mild COLONIC CD (key concept). Controlled ileal-release budesonide 9 mg daily for induction of symptomatic remission in mildly-to-moderately active ileocecal CD (strong, moderate), but recommend AGAINST ileal-release budesonide for MAINTENANCE (strong, low). PERIANAL FISTULIZING: infliximab for induction (strong, moderate); adalimumab (conditional, low); antibiotics added to infliximab or adalimumab (conditional, very low); vedolizumab, ustekinumab, upadacitinib each (conditional, VERY LOW). Drain perianal abscesses and place setons before escalating advanced therapy (key concept).

From our summary of this standard, unedited — the part the paper bears on. marks omitted text. Our wording, not the guideline's; read the source for its own text. The rest of this standard includes DIAGNOSIS, POST-OPERATIVE, SURGERY/ABSCESS and 2 more.

Our full summary of this standard

DIAGNOSIS: Use fecal calprotectin (cutoff >50-100 μg/g) to differentiate inflammatory from noninflammatory disease OF THE COLON (strong, moderate). Ileocolonoscopy with biopsies for suspected CD; biopsy uninvolved mucosa to define histologic extent; small bowel imaging is part of the initial workup (key concepts, ungraded). CT enterography is comparable to MR enterography for small bowel detection; MRE should be used PREFERENTIALLY in patients younger than 35 years and where serial examinations are likely, because of radiation avoidance, MRE is not a blanket first choice. Intestinal ultrasound is a radiation-free ADJUNCT to diagnosis and to monitoring treatment response (key concept, ungraded, not a graded recommendation). Perform routine endoscopic CRC surveillance in Crohn's colitis (strong, moderate). MILD-TO-MODERATE / LOWER PROGRESSION RISK: Recommend AGAINST oral mesalamine for induction or maintenance (strong, moderate); sulfasalazine should be considered ONLY for symptomatic mild COLONIC CD (key concept). Controlled ileal-release budesonide 9 mg daily for induction of symptomatic remission in mildly-to-moderately active ileocecal CD (strong, moderate), but recommend AGAINST ileal-release budesonide for MAINTENANCE (strong, low). MODERATE-TO-SEVERE / HIGHER RISK: SUGGEST AGAINST requiring failure of conventional therapy before initiating advanced therapy (conditional, LOW, a permission to skip step-up, not a mandate to start advanced therapy upfront). Oral corticosteroids for short-term induction only (strong, low). Recommend AGAINST azathioprine 1.5-2.5 mg/kg/d and 6-mercaptopurine 0.75-1.5 mg/kg/d for INDUCTION (strong, moderate), but SUGGEST the same agents and doses for MAINTENANCE after corticosteroid-induced remission (conditional, low). Check TPMT before starting azathioprine/6-MP (strong, low); measure NUDT15 variants in patients of East Asian ancestry and TPMT variants in all patients prior to thiopurine initiation (strong, moderate). Methotrexate up to 25 mg weekly IM/SC for maintenance after corticosteroid induction (conditional, low). Anti-TNF agents (IV infliximab, SC adalimumab, SC certolizumab pegol) for induction and maintenance (strong, moderate). Recommend COMBINATION IV infliximab + thiopurine over either agent alone in patients naive to both (strong, moderate). Vedolizumab IV for induction and maintenance of symptomatic remission (strong, moderate). Ustekinumab (strong, moderate); risankizumab (strong, moderate), and risankizumab over ustekinumab in prior anti-TNF exposure (conditional, low); mirikizumab (strong, moderate); guselkumab IV-then-SC or all-SC (strong, moderate). Upadacitinib for induction and maintenance in patients PREVIOUSLY EXPOSED TO ANTI-TNF (strong, moderate), the ACG does not endorse it as a first-line biologic-naive option. SC infliximab and SC vedolizumab are maintenance options in responders to IV induction (strong, moderate). PERIANAL FISTULIZING: infliximab for induction (strong, moderate); adalimumab (conditional, low); antibiotics added to infliximab or adalimumab (conditional, very low); vedolizumab, ustekinumab, upadacitinib each (conditional, VERY LOW). Drain perianal abscesses and place setons before escalating advanced therapy (key concept). POST-OPERATIVE: endoscopic assessment at 6-12 months after surgically induced remission over no monitoring (conditional, moderate); in LOW post-op recurrence risk, continued observation rather than immediate medical therapy (conditional, very low); imidazole antibiotics (metronidazole) 1-2 g/d after small intestinal resection (conditional, low); in HIGH-risk CD, anti-TNF to prevent endoscopic recurrence (STRONG, moderate) and vedolizumab (CONDITIONAL, low), these two are not co-equal. SURGERY/ABSCESS: intra-abdominal abscess >2 cm should be treated with antibiotics plus a drainage procedure, and immunosuppression HELD until drainage is achieved (conditional, low). DISEASE MODIFIERS: counsel active smokers to quit; use NSAIDs with caution; assess stress, depression and anxiety as part of comprehensive care (key concepts).

American College of Gastroenterology, 'ACG Clinical Guideline: Management of Crohn’s Disease in Adults' (Lichtenstein GR, Loftus EV, Afzali A, et al., Am J Gastroenterol 2025;120(6):1225-1264). DOI 10.14309/ajg.0000000000003465, PMID 40701562. · reviewed 2026-07-21 ↗
Ribaldone DG … Caviglia GP · Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association · IF 16.2 · PubMed ↗Permalink
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