Evaluating Upadacitinib in the Treatment of Moderate-to-Severe Active Ulcerative Colitis: Design, Development, and Potential Position in Therapy
Abstract
Upadacitinib is a selective small molecule that inhibits Janus kinase (JAK) type 1. This molecule is administrated orally and is currently approved for the treatment of rheumatoid arthritis, atopic dermatitis, and psoriatic arthritis. Upadacitinib has been approved by the United States Food and Drug Administration for the induction and maintenance therapy of moderate-to-severe ulcerative colitis (UC) and is under investigation by the European Medicines Agency. Data from two induction and two maintenance Phase III randomized controlled trials (RCTs) proved the efficacy of upadacitinib in achieving clinical and endoscopic remission in patients with moderate-to-severe UC, regardless of previous inadequate response to other biologic therapies. The most frequently reported adverse events in the induction trials were acne, creatine phosphokinase increase, nasopharyngitis, headache, and anemia, while in the maintenance studies nasopharyngitis, elevation of creatine phosphokinase, UC exacerbation, upper respiratory tract infection, arthralgia, and anemia were reported. A limited proportion of upadacitinib-treated patients experienced adverse events of special interest, like herpes zoster infections or thromboembolic events, indicating a reliable safety profile. The aim of this review is to summarize the available evidence on upadacitinib in UC providing useful insights about the positioning of this drug in the therapeutic algorithm.
Related
- Upadacitinib as a rescue therapy for steroid- and infliximab-refractory acute severe ulcerative colitis: short- and long-term effectiveness and safety in a multicenter cohort study
- ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment
- Efficacy and safety of upadacitinib in adults and adolescents for treatment of non-segmental vitiligo (Viti-Up): results of two phase 3 randomised controlled studies
- Identification of Potential Biomarkers for Ulcerative Colitis and Analysis of Immune Cell Infiltration: A Study Based on Data-Independent Acquisition Proteomics and the GEO Public Database.
- Therapeutic Potential of Propolis in Ulcerative Colitis: A Review of Preclinical Evidence.
BibTeX
@article{napolitano2026evaluating,
title = {{Evaluating Upadacitinib in the Treatment of Moderate-to-Severe Active Ulcerative Colitis: Design, Development, and Potential Position in Therapy}},
author = {Maria Napolitano and Ferdinando d'Amico and Elisa Ragaini and Laurent Peyrin-Biroulet and Silvio Danese},
journal = {Drug Design, Development and Therapy},
year = {2026},
month = aug,
doi = {10.2147/dddt.s340459},
url = {https://hal.univ-lorraine.fr/hal-04165814v1},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Evaluating Upadacitinib in the Treatment of Moderate-to-Severe Active Ulcerative Colitis: Design, Development, and Potential Position in Therapy
AU - Maria Napolitano
AU - Ferdinando d'Amico
AU - Elisa Ragaini
AU - Laurent Peyrin-Biroulet
AU - Silvio Danese
PY - 2026
DA - 2026/08/31
JO - Drug Design, Development and Therapy
DO - 10.2147/dddt.s340459
UR - https://hal.univ-lorraine.fr/hal-04165814v1
AB - Upadacitinib is a selective small molecule that inhibits Janus kinase (JAK) type 1. This molecule is administrated orally and is currently approved for the treatment of rheumatoid arthritis, atopic dermatitis, and psoriatic arthritis. Upadacitinib has been approved by the United States Food and Drug Administration for the induction and maintenance therapy of moderate-to-severe ulcerative colitis (UC) and is under investigation by the European Medicines Agency. Data from two induction and two maintenance Phase III randomized controlled trials (RCTs) proved the efficacy of upadacitinib in achieving clinical and endoscopic remission in patients with moderate-to-severe UC, regardless of previous inadequate response to other biologic therapies. The most frequently reported adverse events in the induction trials were acne, creatine phosphokinase increase, nasopharyngitis, headache, and anemia, while in the maintenance studies nasopharyngitis, elevation of creatine phosphokinase, UC exacerbation, upper respiratory tract infection, arthralgia, and anemia were reported. A limited proportion of upadacitinib-treated patients experienced adverse events of special interest, like herpes zoster infections or thromboembolic events, indicating a reliable safety profile. The aim of this review is to summarize the available evidence on upadacitinib in UC providing useful insights about the positioning of this drug in the therapeutic algorithm.
SN - 1177-8881
ER -