P0979 Real-world effectiveness and safety of selective JAK inhibitors in ulcerative colitis and Crohn’s disease: A retrospective, mul-ticenter study

Abstract Background Data on the real-world effectiveness and safety of selective JAK inhibitors (JAKis) in ulcerative colitis (UC) and Crohn’s disease (CD) are limited. Methods We conducted a multicenter, retrospective study to assess clinical, biochemical, and endoscopic outcomes of selective JAKis in bio-experienced UC and CD patients. Corticosteroid-free clinical remission (CSFCR) was defined as clinical remission (CR; CDAI<150 in CD, and partial Mayo score ≤2 with a rectal bleeding subscore of 0 in UC) and not receiving local and systemic steroids ≥90 days before the assessment time point. Biochemical remission was defined as a serum C-reactive protein (CRP) level of ≤5 mg/L and a fecal calprotectin (FC) level of ≤150 µg/g. Endoscopic remission was defined as an endoscopic Mayo score of 0 in UC, and a Simple Endoscopic Score-CD of ≤4 points in CD patients. Therapeutic response was only assessed in patients who had the required data available at the specific time point („as observed analysis”). Multivariable logistic regression models were used to investigate predictors of CR at the end of the induction phase (at week 12 in CD, and at week 8 in UC patients). The potential impact of switching from tofacitinib to upadacitinib on therapeutic effectiveness was also assessed. Results 131 UC and 115 CD patients were included with a median follow-up of 7.5 months (Table 1.). Among the CD patients receiving upadacitinib (n=115), 76.2% achieved clinical remission (CR) at week 12. Furthermore, 59.5% of upadacitinib-treated UC patients (n=100) experienced CR at week 8. Corticosteroid-free CR (CSFCR) was achieved by 76.9% of CD patients and 80.6% of UC patients at week 24, while 50.0% and 36.1% experienced endoscopic remission. At week 52, 66.7% of CD and 86.2% of UC patients achieved CSFCR, whereas 54.5% and 52.9% had endoscopic remission. In UC, the effectiveness of upadacitinib was not compromised by prior tofacitinib failure, while upadacitinib-treated CD patients with stricturing and penetrating disease were less likely to achieve CR by the end of the induction phase (p=.04). CRP (p[CD]<.0001; p[UC]<.0001) and FC (p[CD]<.0001; p[UC]=.02) decreased significantly in both patient groups as early as week 2. Among filgotinib-treated UC patients (n=31), 28.6% were in CR at week 12. At week 24 and 52, 59.1% and 60% achieved CSFCR, while 0.0% and 20.0% had endoscopic remission. Both CRP (p=.04) and FC (p=.04) decreased significantly by week 12. The three most common adverse events were hyperlipidaemia, acne and varicella zoster virus infection, all with a frequency of less than 10%. Conclusion Selective JAKis are rapidly effective and safe for treating refractory, moderate-to-severe CD and UC.

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