Author
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Outcome measures
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Efficacy outcomes
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Adverse events
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Conclusions
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Colombel et al. [16]
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Daily SF, APS, SF/APS clinical remission, CDAI clinical remission, SF/APS clinical response, CR-100
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SF/APS clinical remission achieved earlier with upadacitinib (median 13 days) vs. placebo (median 32 days); Higher rates of SF/APS clinical remission, CDAI clinical remission, SF/APS clinical response, and CR-100 with upadacitinib vs. placebo from week 2 through week 12. Rapid symptom relief (SF/APS clinical remission) observed within five to six days of upadacitinib treatment
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Not reported in this post hoc analysis
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Upadacitinib 45 mg once daily provided rapid relief of CD symptoms within the first week of treatment and improved clinical outcomes starting at week 2, regardless of prior biologic exposure
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Elford et al. [19]
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Treatment persistence: Week 12: 87.1%, Week 24: 81.7%, Week 52: 62.8%
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Clinical remission rates: Week 12: 64% (42/66), Week 24: 48% (22/46), Week 52: 38% (8/21); CRP remission rates: Week 12: 55% (40/73), Week 24: 38% (20/53), Week 52: 19% (6/22); Fecal calprotectin remission rates: Week 12: 50% (24/48), Week 24: 36% (15/42), Week 52: 19% (3/16)
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Total adverse events: 40% (37/93); Serious adverse events: 12% (11/93); Most common adverse event: Infection (15%); Adverse events causing permanent medication cessation: 10% (9/93)
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Upadacitinib was effective in a real-world, highly medically refractory CD cohort with good persistence. No new safety signals were observed.
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Peyrin-Biroulet et al. [17]
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Clinical remission, endoscopic response, normalization of inflammation markers (CRP and fecal calprotectin), safety (adverse events)
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Upadacitinib significantly outperformed placebo in clinical remission, endoscopic response, endoscopic remission, and CRP normalization at both 12 and 52 weeks, regardless of prior biologic failure status
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Similar rates of adverse events between upadacitinib and placebo groups; rare serious infections, herpes zoster, neutropenia, and malignancies
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Upadacitinib showed improved clinical and endoscopic outcomes in patients with CD, regardless of biologic treatment history
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Loftus et al. [18]
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Primary: Clinical remission (CDAI score <150) and endoscopic response (decrease in SES-CD >50% from baseline) at week 12 (induction) and week 52 (maintenance)
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Induction (45 mg vs. placebo): Clinical remission: U-EXCEL 49.5% vs. 29.1%, U-EXCEED 38.9% vs. 21.1%; Endoscopic response: U-EXCEL 45.5% vs. 13.1%, U-EXCEED 34.6% vs. 3.5% (all p < 0.001). Maintenance (15 mg, 30 mg vs. placebo): Clinical remission: 37.3%, 47.6% vs. 15.1%; Endoscopic response: 27.6%, 40.1% vs. 7.3% (all p < 0.001)
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Induction: Higher rates of herpes zoster, neutropenia, and creatine kinase elevation with upadacitinib. Maintenance: Dose-dependent increases in herpes zoster, hepatic disorders, neutropenia, and creatine kinase elevation
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Upadacitinib was superior to placebo for induction and maintenance of clinical remission and endoscopic response in patients with moderate-to-severe CD, regardless of previous failure of biologic therapy
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Friedberg et al. [20]
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Clinical response and remission (HBI for CD), CRP, fecal calprotectin
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76.5% clinical response, 70.6% clinical remission at week 8
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32.4% experienced adverse events. Most common: acne (22.9%). Six patients discontinued due to AEs; one SAE (hospitalization for anemia)
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Upadacitinib demonstrated rapid efficacy and acceptable safety in medically resistant UC and CD patients, including those previously exposed to tofacitinib
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D'Haens et al. [21]
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Clinical remission, enhanced clinical response, CDAI remission, endoscopic remission, endoscopic response, steroid-free remission, IBDQ remission, hsCRP and FCP levels, safety outcomes
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Clinical remission 2.8/1.0 maintained at 30 months: 61% (15 mg), 54% (30 mg), 55% (dose-escalated); Enhanced clinical response at 30 months: 85% (15 mg), 74% (30 mg), 70% (dose-escalated); Endoscopic remission at 24 months: 34% (15 mg), 43% (30 mg), 0% (dose-escalated); Sustained or improved hsCRP and FCP levels across all groups
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Overall AEs: 89.7% of patients (374.6 events/100 patient-years); Serious AEs: 18.7% of patients (15.3 events/100 patient-years); Most common AEs: infections (67.3% of patients); Herpes zoster: 4.7% of patients (3.1 events/100 patient-years); No new safety signals identified
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Long-term treatment with upadacitinib led to sustained clinical and endoscopic improvements decreased inflammation markers, and increased patient-reported quality of life benefits in patients with CD who were mostly refractory to TNF therapy. The safety profile was consistent with previous upadacitinib studies and that of other JAK inhibitors
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Sandborn et al. [22]
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Primary: Clinical remission at week 16, Endoscopic remission at week 12/16; Secondary: Clinical response, Endoscopic response, CDAI <150, Corticosteroid-free remission, Changes in biomarkers (hs-CRP, fecal calprotectin), Quality of life (IBDQ)
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Endoscopic remission at week 12/16: significant dose-response relationship, highest with 24 mg BID (22%, p < 0.01 vs. placebo); Clinical remission at week 16: highest with 6 mg BID (27%, p < 0.1 vs. placebo); Maintenance: 12 mg BID showed highest rates of clinical and endoscopic endpoints at week 52 (not statistically significant); Significant improvements in quality of life (IBDQ) with upadacitinib vs. placebo
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Higher incidence of AEs at doses >12 mg BID; Most common AEs: headache, worsening CD, abdominal pain, fatigue, upper respiratory tract infection, urinary tract infection, nausea, vomiting, acne; Serious infections, herpes zoster, and lipid elevations were observed; Two intestinal perforations during induction (both with 24 mg doses); No deaths occurred
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Upadacitinib was superior to placebo in inducing endoscopic improvements in patients with moderate to severe CD refractory to biologics. Maintenance therapy led to sustained clinical, endoscopic, and patient-reported benefits. Further evaluation in phase 3 trials is warranted
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