TY - JOUR
T1 - Upadacitinib Induction and Maintenance Therapy Improves Abdominal Pain, Bowel Urgency, and Fatigue in Patients With Ulcerative Colitis
T2 - A Post Hoc Analysis of Phase 3 Data
AU - Danese, Silvio
AU - Tran, Jacinda
AU - D'Haens, Geert
AU - Rubin, David T.
AU - Aoyama, Nobuo
AU - Zhou, Wen
AU - Ilo, Dapo
AU - Yao, Xuan
AU - Sanchez Gonzalez, Yuri
AU - Panaccione, Remo
N1 - Funding Information: S.D. has received consultancy fees from AbbVie, Allergan, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Ferring, Gilead, Hospira, Janssen, Johnson & Johnson, MSD, Mundipharma, Pfizer, Roche, Sandoz, Takeda, TiGenix, UCB, and Vifor Pharma. J.T. was a summer intern at AbbVie at the time this study was conducted; is currently an AbbVie contractor and PhD student at University of Washington; and has received financial support from the Agency for Healthcare Research and Quality, National Institutes of Health, ARCS Foundation, and Washington Research Foundation. Funding Information: This work was supported by AbbVie Inc. AbbVie participated in the study design, research, data collection, analysis and interpretation of data, writing, reviewing, and approving the publication. No honoraria or payments were made for authorship. Funding Information: Medical writing support was provided by Natalie Mitchell, of Fishawack Facilitate Ltd, part of Fishawack Health, and funded by AbbVie. At all study sites, the protocol and all study-related recruitment materials were approved by institutional review board or independent ethics committee. Written informed consent was obtained from all participants before study enrolment. Ethical principles outlined in the current Declaration of Helsinki, Good Clinical Practice guidelines, and local regulatory requirements were applied in the conduct of this study. All patient data were anonymized to maintain patient confidentiality. Funding Information: G.D. has served as an adviser for AbbVie, Ablynx, Allergan, Alphabiomics, Amakem, Amgen, AM Pharma, Arena Pharmaceuticals, AstraZeneca, Avaxia, Biogen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene/Receptos, Celltrion, Cosmo, Echo Pharmaceuticals, Eli Lilly, Engene, Ferring, Dr. Falk Pharma, Galapagos, Genentech/Roche, Gilead, Glaxo Smith Kline, Gossamerbio, Hospira/Pfizer, Immunic, Johnson and Johnson, Kintai Therapeutics, Lycera, Medimetrics, Millennium/Takeda, Medtronics, Mitsubishi Pharma, Merck Sharp Dome, Mundipharma, Nextbiotics, Novo Nordisk, Otsuka, Pfizer/Hospira, Photopill, Prodigest, Prometheus Laboratories/Nestlé, Progenity, Protagonist, RedHill, Robarts Clinical Trials, Salix, Samsung Bioepis, Sandoz, Seres/Nestle, Setpoint, Shire, Teva, Tigenix, Tillotts, Topivert, Versant, and Vifor; and has received speaker fees from AbbVie, Biogen, Ferring, Johnson and Johnson, Merck Sharp Dome, Mundipharma, Norgine, Pfizer, Samsung Bioepis, Shire, Millennium/Takeda, Tillotts, and Vifor. D.T.R. has received grant support from Takeda; and served as a consultant for AbbVie, Altrubio, Arena Pharmaceuticals, Bellatrix Pharmaceuticals, Boehringer Ingelheim Ltd, Bristol-Myers Squibb, Celgene Corp/Syneos, Connect BioPharma, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, InDex Pharmaceuticals, Ironwood Pharmaceuticals, Iterative Scopes, Janssen Pharmaceuticals, Lilly, Materia Prima, Pfizer, Prometheus Biosciences, Reistone, Takeda, and Techlab Inc. N.A. has no conflict of interest to report. Publisher Copyright: © 2023 Crohn’s & Colitis Foundation.
PY - 2023/11/1
Y1 - 2023/11/1
N2 - Background: This post hoc analysis of a large, phase 3 program evaluated the effects of upadacitinib on fatigue, bowel urgency, and abdominal pain in patients with moderately to severely active ulcerative colitis. Methods: Induction data were pooled from 2 identical studies, the U-ACHIEVE induction and U-ACCOMPLISH studies. Patients in these studies received upadacitinib 45 mg once daily or placebo as induction treatment. Responders to induction treatment were rerandomized in the U-ACHIEVE maintenance study to upadacitinib 15 mg once daily, upadacitinib 30 mg, or placebo. The percentage of patients reporting no abdominal pain and no bowel urgency daily via an electronic diary and a meaningful within-person change (≥5 points) in the Functional Assessment of Chronic Illness Therapy–Fatigue score were evaluated. Results: The results demonstrated a statistically significantly greater percentage of patients reporting no abdominal pain and absence of bowel urgency observed from week 2 (P < .001), with upadacitinib induction treatment and clinically meaningful improvements in Functional Assessment of Chronic Illness Therapy–Fatigue score observed at week 8 (P < .001), when compared with placebo. The maintenance study showed that significant and meaningful improvements in abdominal pain, bowel urgency, and Functional Assessment of Chronic Illness Therapy–Fatigue score achieved during induction were sustained through 52 weeks of maintenance treatment in upadacitinib- vs placebo-treated patients. Conclusions: The findings of this study support the additional benefit of upadacitinib in treating moderately to severely active ulcerative colitis by demonstrating a statistically significant impact on clinically meaningful symptoms of fatigue, bowel urgency, and abdominal pain. (U-ACHIEVE induction and maintenance studies; NCT02819635; U-ACCOMPLISH induction study; NCT03653026).
AB - Background: This post hoc analysis of a large, phase 3 program evaluated the effects of upadacitinib on fatigue, bowel urgency, and abdominal pain in patients with moderately to severely active ulcerative colitis. Methods: Induction data were pooled from 2 identical studies, the U-ACHIEVE induction and U-ACCOMPLISH studies. Patients in these studies received upadacitinib 45 mg once daily or placebo as induction treatment. Responders to induction treatment were rerandomized in the U-ACHIEVE maintenance study to upadacitinib 15 mg once daily, upadacitinib 30 mg, or placebo. The percentage of patients reporting no abdominal pain and no bowel urgency daily via an electronic diary and a meaningful within-person change (≥5 points) in the Functional Assessment of Chronic Illness Therapy–Fatigue score were evaluated. Results: The results demonstrated a statistically significantly greater percentage of patients reporting no abdominal pain and absence of bowel urgency observed from week 2 (P < .001), with upadacitinib induction treatment and clinically meaningful improvements in Functional Assessment of Chronic Illness Therapy–Fatigue score observed at week 8 (P < .001), when compared with placebo. The maintenance study showed that significant and meaningful improvements in abdominal pain, bowel urgency, and Functional Assessment of Chronic Illness Therapy–Fatigue score achieved during induction were sustained through 52 weeks of maintenance treatment in upadacitinib- vs placebo-treated patients. Conclusions: The findings of this study support the additional benefit of upadacitinib in treating moderately to severely active ulcerative colitis by demonstrating a statistically significant impact on clinically meaningful symptoms of fatigue, bowel urgency, and abdominal pain. (U-ACHIEVE induction and maintenance studies; NCT02819635; U-ACCOMPLISH induction study; NCT03653026).
KW - biologic therapies
KW - quality of life
KW - ulcerative colitis
UR - http://www.scopus.com/inward/record.url?scp=85176496959&partnerID=8YFLogxK
U2 - https://doi.org/10.1093/ibd/izad016
DO - https://doi.org/10.1093/ibd/izad016
M3 - Article
C2 - 36790041
SN - 1078-0998
VL - 29
SP - 1723
EP - 1729
JO - Inflammatory Bowel Diseases
JF - Inflammatory Bowel Diseases
IS - 11
ER -