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Clinical Trial
. 2025 Feb 6;31(2):394-403.
doi: 10.1093/ibd/izae200.

Induction of Endoscopic Response, Remission, and Ulcer-Free Endoscopy With Upadacitinib Is Associated With Improved Clinical Outcomes and Quality of Life in Patients With Crohn's Disease

Julian Panés  1 , Edouard Louis  2 , Peter Bossuyt  3 , Namita Joshi  4 , Wan-Ju Lee  4 , Ana P Lacerda  4 , Kristina Kligys  4 , Si Xuan  4 , Nidhi Shukla  4 , Edward V Loftus Jr  5
Affiliations
Clinical Trial

Induction of Endoscopic Response, Remission, and Ulcer-Free Endoscopy With Upadacitinib Is Associated With Improved Clinical Outcomes and Quality of Life in Patients With Crohn's Disease

Julian Panés et al. Inflamm Bowel Dis. .

Abstract

Background: We evaluated the association of achieving endoscopic outcomes at week 12 of induction with improvements in clinical outcomes and quality of life (QoL) at week 52 of maintenance in patients with moderately to severely active Crohn's disease (CD) treated with upadacitinib (UPA).

Methods: This post hoc analysis evaluated data from 2 phase 3 induction trials (NCT03345836 and NCT03345849) and 1 maintenance (NCT03345823) trial. Clinical responders to 12-week induction therapy with UPA who also received 52-week maintenance treatment with UPA were included. Endoscopic response, remission, healing, and ulcer-free endoscopy were assessed at week 12. Meaningful improvements in clinical and QoL outcomes were evaluated at week 52.

Results: A significantly greater proportion of patients who achieved an endoscopic response at the end of induction, compared with patients who did not, attained Crohn's Disease Activity Index (CDAI) remission (52.0% vs 34.6%; P ≤ .01), corticosteroid-free CDAI remission (50.0% vs 30.9%), Inflammatory Bowel Disease Questionnaire remission (52.6% vs 30.3%), and meaningful improvements in Functional Assessment of Chronic Illness Therapy-Fatigue response (46.7% vs 25.9%), overall work impairment (47.1% vs 26.5%), and daily activity impairment (53.3% vs 34.1%) (all P < .05) at week 52. Similar findings were observed for patients who achieved endoscopic remission, endoscopic healing, and ulcer-free endoscopy at the end of induction vs those who did not.

Conclusions: Early improvement in endoscopic outcomes after UPA induction treatment was associated with long-term meaningful improvements in clinical outcomes and QoL in patients with CD.

Clinical registration number: U-EXCEED induction trial (NCT03345836), U-EXCEL induction trial (NCT03345849), and U-ENDURE maintenance trial (NCT03345823).

Keywords: Crohn’s disease; clinical trials; endoscopy; quality of life; upadacitinib.

Plain language summary

In patients with Crohn’s disease treated with 12 weeks of upadacitinib, a greater proportion with early improvements in endoscopic response, remission, healing, and ulcer-free endoscopy, vs those without improvements, attained long-term meaningful improvements in clinical outcomes and quality of life.

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Conflict of interest statement

J.P. received financial support for research from AbbVie and Pfizer; received consultancy fees/honorarium from AbbVie, Arena, Athos, Atomwise, Boehringer Ingelheim, Celgene, Celltrion, Ferring, Galapagos, Genentech/Roche, GlaxoSmithKline, Janssen, Mirum, Morphic, Nestlé, Origo, Pandion, Pfizer, Progenity, Protagonist, Revolo, Robarts, Takeda, Theravance, and Wasserman; reports payment for lectures including service on speaker bureau from Abbott, Ferring, Janssen, Pfizer, and Takeda; and reports payment for development of educational presentations from Abbott, Janssen, Pfizer, Roche, and Takeda. E.L. received research grants from Janssen, Pfizer, and Takeda; educational grant from AbbVie, Janssen, MSD, and Takeda; speaker fees for AbbVie, Falk, Ferring, Hospira, Janssen, MSD, Pfizer, and Takeda; served on an advisory board for AbbVie, Celgene, Ferring, Hospira, Janssen, MSD, Pfizer, Takeda, Galapagos, Gilead, and Arena; and served as a consultant for AbbVie. P.B. received research grants from AbbVie, Amgen, Celltrion, Mylan, Pfizer, and Takeda; received lecture fees from AbbVie, Celltrion, Janssen, Lilly, and Takeda; and served as a consultant for AbbVie, Arena Pharmaceuticals, BMS, Celltrion, Dr Falk, Galapagos, Janssen, Lilly, Pentax, PSI-CRO, Roche, Takeda, and Tetrameros. N.J., W.-J.L., A.P.L., K.K., and S.X. are full-time salaried employees of AbbVie and may own stock/options. N.S. is a contractor of AbbVie. E.V.L. served as a consultant for AbbVie, Alvotech, Amgen, Arena, Astellas, Avalo Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion Healthcare, Eli Lilly, Fresenius Kabi, Genentech, Gilead, GlaxoSmithKline, Gossamer Bio, Iota Biosciences, Iterative Scopes, Janssen, KSL Diagnostics, Morphic Therapeutics, Ono Pharma, Protagonist, Surrozen, Sun Pharma, Takeda, TR1X Bio, and UCB; received research grants from AbbVie, AstraZeneca, Bristol Myers Squibb, Celgene, Genentech, Gilead, Gossamer Bio, Janssen, Pfizer, Receptos, Takeda, Theravance, and UCB; and is a shareholder of Exact Sciences.

Figures

Figure 1.
Figure 1.
Study design. Abbreviations: CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy—Fatigue; f-cal, fecal calprotectin; hs-CRP, high-sensitivity C-reactive protein; IBDQ, Inflammatory Bowel Disease Questionnaire; MCS, Mental Component Score; PCS, Physical Component Score; QD, once daily; SF-36, Short Form 36; UPA, upadacitinib; WPAI, Work Productivity and Activity Impairment Questionnaire.
Figure 2.
Figure 2.
Clinical outcomes at week 52 among patients who achieved (A) an endoscopic response, (B) endoscopic remission, (C) endoscopic healing, or (D) ulcer-free endoscopy at the end of induction, compared with patients who did not. *Nominal P-value ≤.05; **nominal P-value ≤.01; ***nominal P-value <.001. Abbreviations: AP, abdominal pain; CDAI, Crohn’s Disease Activity Index; f-cal, fecal calprotectin level; hs-CRP, high-sensitivity C-reactive protein; SF, stool frequency.
Figure 3.
Figure 3.
Meaningful improvement in QoL outcomes at week 52 among patients who achieved (A) an endoscopic response, (B) endoscopic remission, (C) endoscopic healing, or (D) ulcer-free endoscopy at the end of induction, compared with patients who did not. *Nominal P-value ≤.05; **nominal P-value ≤.01; ***nominal P-value <.001. WPAI was reported for employed patients only. Abbreviations: FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy—Fatigue; IBDQ, Inflammatory Bowel Disease Questionnaire; MCS, Mental Component Score; PCS, Physical Component Score; QoL, quality of life; SF-36, Short Form 36; WPAI, Work Productivity and Activity Impairment Questionnaire.
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