NORTH CHICAGO, October 20, 2025 – AbbVie Inc. (ABBV.N) said its newer arthritis drug Rinvoq demonstrated superiority over blockbuster predecessor Humira in a head-to-head clinical trial. The results bolster AbbVie’s strategy to transition patients from its former top-seller to newer immunology treatments as Humira faces biosimilar competition.
- Rinvoq achieved 43.3% patient improvement versus 22.4% for Humira
- Study focused on rheumatoid arthritis patients who failed first treatment
- Results support AbbVie’s post-Humira immunology portfolio transition
Study Results
In the Phase 3 trial, 43.3% of patients receiving Rinvoq (upadacitinib) achieved low disease activity and remission at week 12, compared with 22.4% of patients on Humira (adalimumab) 1. The study enrolled patients with rheumatoid arthritis who had failed their first TNF inhibitor treatment.
Upadacitinib demonstrated superiority in achieving the primary endpoint in nearly twice as many patients compared to adalimumab, according to AbbVie’s announcement 2. The oral JAK inhibitor Rinvoq received FDA approval for rheumatoid arthritis in 2019.
Market Context
The positive data comes as AbbVie works to offset declining Humira revenues following the introduction of biosimilar competitors in the U.S. market in 2023. Humira generated over 21 billion in global sales at its peak in 2022 before facing generic competition.
AbbVie’s newer immunology drugs Rinvoq and Skyrizi have emerged as key growth drivers, with combined sales reaching 7.8 billion in 2023. The company has positioned these treatments as next-generation therapies with improved efficacy profiles.
Clinical Significance
The head-to-head comparison provides valuable real-world evidence for physicians treating rheumatoid arthritis patients who have not responded adequately to initial TNF inhibitor therapy. Previous five-year data from the SELECT-COMPARE study showed clinical responses were numerically higher with upadacitinib versus adalimumab 3.
Rheumatoid arthritis affects approximately 1.3 million adults in the United States, creating a substantial market opportunity for effective treatments. The condition causes joint inflammation, pain, and potential disability without proper management.
Product Transition Strategy
AbbVie has pursued what industry observers call “product hopping” – transitioning patients from Humira to newer branded alternatives before biosimilar competition intensifies 4. This strategy has proven successful, with Skyrizi recently overtaking Humira in certain market segments.
The company’s immunology franchise generated 17.3 billion in revenue during the first nine months of 2024, with Rinvoq contributing 3.2 billion and Skyrizi adding 6.5 billion. These newer products are expected to drive long-term growth as Humira sales continue declining.
Regulatory Outlook
The new clinical data may support additional regulatory submissions and label expansions for Rinvoq across different patient populations. AbbVie continues investing in clinical programs to demonstrate the drug’s efficacy in various inflammatory conditions beyond rheumatoid arthritis.
Rinvoq is currently approved for multiple indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and atopic dermatitis. The broad label provides multiple revenue opportunities as the company builds its post-Humira portfolio.
Not investment advice. For informational purposes only.
References
1(2025). “AbbVie’s Rinvoq shows superiority over Humira in head-to-head study”. TradingView/Reuters. Retrieved October 20, 2025.
2(2025). “RINVOQ (upadacitinib) Demonstrated Superiority Versus HUMIRA”. PR Newswire. Retrieved October 20, 2025.
3(May 28, 2024). “5-year data from the phase 3, randomised SELECT-COMPARE study”. PMC. Retrieved October 20, 2025.
4(Nov 7, 2024). “Skyrizi Overtakes Humira: Product Hopping Leaves Biosimilar Market in Limbo”. Center for Biosimilars. Retrieved October 20, 2025.