Written By: Arbaz Saiyyad, DPharm, BSc, BPharm
Reviewed By: Pharmacally Editorial Team
On October 13, 2025, the FDA approved an updated indication statement for RINVOQ (upadacitinib), an oral selective Janus kinase (JAK) inhibitor. Under the new labeling, physicians now may prescribe RINVOQ to adult patients with moderately to severely active ulcerative colitis or Crohn’s disease who has already received at least one approved systemic therapy even if TNF blockers are clinically inadvisable for that individual.
Earlier, RINVOQ was restricted to use after failure or intolerance to one or more TNF inhibitor therapies. The revised label permits use earlier in the treatment algorithm, broadening options for patients unable to tolerate or safely receive TNF inhibitors due to prior history, side effects, or clinical risks.
What Patients and Providers Need to Know
RINVOQ is now available to patients who have received any one approved systemic therapy (such as corticosteroids or immunomodulators), if TNF blockade is deemed unsuitable for clinical reasons.
The FDA’s decision was supported by data demonstrating upadacitinib efficacy in inducing and maintaining remission in both ulcerative colitis and Crohn’s disease.
This label update was lauded by experts Kori Wallace, MD, PhD (AbbVie) noted, “Ulcerative colitis and Crohn’s disease can impact every aspect of a patient’s life. This label update gives healthcare providers the option to prescribe Rinvoq for patients with moderately to severely active inflammatory bowel disease after the use of one approved systemic therapy if TNF blockers are deemed clinically inadvisable by the prescribing physician.”
Clinical Trial Evidence Supporting Use
Pivotal phase 3 clinical trials U-EXCEED, U-EXCEL, and U-ENDURE demonstrated that upadacitinib provided significant clinical remission and endoscopic response in adult patients with moderately to severely active Crohn’s disease. Similar durable efficacy and safety signals were reported in trials for ulcerative colitis, showcasing RINVOQ’s role as a potent oral immunomodulator.
Dosing and Safety Information
Typically, 45 mg daily for 8-12 weeks, followed by 15 or 30 mg daily for maintenance, adjusted per indication and clinical response.
Safety: RINVOQ’s label contains boxed warnings for serious infections, malignancy, and thrombosis. It is not recommended for use with other JAK inhibitors, biological therapies for IBD, or potent immunosuppressants (e.g., azathioprine, cyclosporine).
Lab Monitoring: Periodic laboratory tests for blood counts, liver function, and lipids are advised during treatment.
Implications for Practice
The FDA’s expanded indication bridges a critical gap for IBD patients ineligible for TNF blockers. It empowers clinicians to begin RINVOQ earlier when individual patient profiles or risk factors make anti-TNF therapy unsuitable.
Patients with a need for earlier disease control or a history of adverse reactions to TNF inhibitors may now benefit from RINVOQ, potentially improving outcomes and quality of life.
Reference
U.S. Food and Drug Administration (FDA) Approves Updated Indication Statement for RINVOQ® (upadacitinib) for the Treatment of Inflammatory Bowel Disease, AbbVie, 13 October 2025, https://news.abbvie.com/2025-10-13-U-S-Food-and-Drug-Administration-FDA-Approves-Updated-Indication-Statement-for-RINVOQ-R-upadacitinib-for-the-Treatment-of-Inflammatory-Bowel-Disease
U.S. Food and Drug Administration (FDA) Approves Updated Indication Statement for RINVOQ® (upadacitinib) for the Treatment of Inflammatory Bowel Disease, PR Newswire, 13 Oct 2025, https://www.prnewswire.com/news-releases/us-food-and-drug-administration-fda-approves-updated-indication-statement-for-rinvoq-upadacitinib-for-the-treatment-of-inflammatory-bowel-disease-302582159.html
Highlights of prescribing information, RINVOQ® (upadacitinib) extended-release tablets, for oral use, https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211675s025lbl.pdf