UPADACITINIB

Upadacitinib is an oral selective Janus kinase (JAK) inhibitor developed by AbbVie for autoimmune and inflammatory conditions. JAK inhibition research commenced in the early 2000s, with Upadacitinib designed as a more selective inhibitor than earlier JAK agents, intended to enhance efficacy whilst minimising side effects. The U.S. FDA approved Upadacitinib in August 2019 for moderate to severe rheumatoid arthritis in adults with inadequate response or intolerance to methotrexate. Subsequent approvals followed for psoriatic arthritis, atopic dermatitis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and ulcerative colitis across the U.S., Europe, and Asia.

Upadacitinib is used in the treatment of: Rheumatoid Arthritis (RA) – moderate to severe, in patients unresponsive to methotrexate. Psoriatic Arthritis (PsA) – for patients with inadequate response to conventional therapy. Atopic Dermatitis (AD) – moderate to severe cases where systemic therapy is appropriate. Ankylosing Spondylitis (AS) – active cases not responding to conventional treatments. Ulcerative Colitis (UC) – moderately to severely active disease after inadequate response to other medicines.

Common (mild to moderate): Upper respiratory tract infections Nausea, headache, or stomach pain Acne Fatigue or dizziness Cough or fever. Serious (seek urgent medical attention): Severe infections (TB, shingles, pneumonia) Blood clots in the veins or lungs Chest pain or shortness of breath Severe stomach pain or black stools (possible bleeding) Allergic reactions (rash, swelling, breathing difficulty) Liver problems (yellow eyes/skin, dark urine).

Infections: May increase risk of tuberculosis, shingles, or serious bacterial/viral infections. Blood Clots & Heart Risks: Higher risk in patients with cardiovascular disease. Cancer Risk: Rare, but prolonged immunosuppression may slightly raise cancer risk. Liver and Kidney: Requires monitoring of liver/kidney function during treatment. Pregnancy/Breastfeeding: Not recommended; may harm the baby.

Contraception: Use effective birth control during and after treatment. Vaccinations: Avoid live vaccines while taking Upadacitinib. Regular Monitoring: Blood counts, liver enzymes, kidney function, and cholesterol levels should be checked regularly. Medical History : Inform your doctor about heart disease, blood clots, liver problems, or chronic infections.

A Rubbert-Roth et al., “Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis,” The New England Journal of Medicine, [October 2020], demonstrating upadacitinib’s remission rates compared to abatacept in RA patients https://www.nejm.org/doi/full/10.1056/NEJMoa2008250 ? R Sanmartí et al., “Upadacitinib for Patients with Rheumatoid Arthritis,” summarizing the phase II BALANCE I & II trials (dose-ranging) and the phase III SELECT trial program for RA regulatory approval https://pmc.ncbi.nlm.nih.gov/articles/PMC10002765/ ? GR Burmester et al., “Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease,” Advances in Therapy, [2025], analysing long-term safety across multiple disease indications https://pubmed.ncbi.nlm.nih.gov/36754548/ C Zhang et al., “Safety profile and dose-dependent adverse events of upadacitinib: a meta-analysis,” Frontiers in Pharmacology, [2025], highlighting dose-related risks such as hepatic disorders, neutropenia, and acne https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1598972/full