🫀 Sex differences in vedolizumab, ustekinumab, and tofacitinib outcomes—real-world 48-week UC results
🔥 Main in 3 points
- Males on vedolizumab had a more consistent clinical response over time; late remission likelihood was nearly doubled (aOR 1.96).
- Females on tofacitinib showed superior clinical remission at 8 and 24 weeks (p < 0.05).
- Endoscopic and biomarker outcomes (fecal calprotectin) did not differ by sex across all treatments.
🧪 Context
Retrospective, multicenter, bio-experienced UC cohort (n=602, ~50% female); compared vedolizumab, ustekinumab, tofacitinib over 48 weeks for clinical/endoscopic outcomes, steroids use, and biomarkers.
📍 Practical significance
- Consider sex as a factor for tailoring second- or third-line therapy selection in moderate/severe UC.
- For males: vedolizumab may offer persistent benefit; for females: faster remission with tofacitinib is possible.
- Monitoring via endoscopy and fecal calprotectin may not require sex-specific adjustments.
🔗 Source — PubMed | Publisher
🧾 Biologic therapy switches in IBD: patterns and predictors
✅ Do
- Expect anti-TNF (infliximab, adalimumab) as main first/second biologics in Crohn’s and UC.
- Use non-anti-TNFs (vedolizumab, ustekinumab) mostly as third-line options after anti-TNF failure.
- Monitor patients with family history (CD) or young age <30 (UC) for higher likelihood of switching.
⚠️ With caution
- Infliximab shows longer persistence than adalimumab before switch, especially in UC (47 vs 23 months).
- Switching is more likely in younger UC, and in CD with positive family history.
🚫 Avoid
- Early cycling through multiple classes without clear indication; persistence data favours optimising current regimen first.
🔗 Source — PubMed | Publisher
🫀 Vedolizumab, upadacitinib & trial design: histology/fecal calprotectin thresholds don’t lower placebo rates
🧪 What was studied
Patient-level pooled analysis from 5 phase 3 ulcerative colitis RCTs (n=1,918 active/1,149 placebo), including vedolizumab and upadacitinib, testing if stricter baseline histology or fecal calprotectin (FC) inclusion reduced placebo response.
📈 Key results
- Neither FC (>150 to >500 µg/g) nor histology thresholds (Geboes ≥3.1/3.2) meaningfully reduced placebo response or increased drug-placebo separation.
- Up to 38% of patients would be excluded by such criteria, with minimal gain in clinical remission difference (vedolizumab CR diff ~11% both ways).
📍 What this changes in practice
- Routine exclusion of trial candidates by baseline FC or histology is not justified for lowering placebo rates, even for vedolizumab or JAK inhibitors.
- Optimize eligibility using conventional clinical criteria without over-reliance on FC/histology cut-offs.
🔗 Source — PubMed | Publisher
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