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Safety Profile of RINVOQ™ (upadacitinib): Analysis of Up to ~3.5 Years of Exposure in Patients With Rheumatoid Arthritis

Jul 01, 2020 9:00 am

Analysis of Safety Data From the SELECT Clinical Trial Program

Sponsored by AbbVie Medical Affairs

RINVOQTM (upadacitinib, UPA) is a Janus kinase (JAK) inhibitor approved by the US Food and Drug Administration for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX).1 The approval was based on data from ~4400 patients in the SELECT Phase 3 clinical program, where UPA met all primary (≥20% improvement in the American College of Rheumatology response criteria (ACR20) at week 12 or 14 vs placebo or MTX, or ≥50% improvement in the American College of Rheumatology response criteria (ACR50) at week 12 vs MTX) and ranked secondary endpoints across 5 clinical studies.1-7 In one study, UPA + MTX was superior to adalimumab (ADA) + MTX for the following ranked secondary endpoints: (ACR50), change in Health Assessment Questionnaire Disability Index (HAQ-DI), and change in patient's assessment of pain at week 12.2 Clinical remission, including stringent definitions that allow for no more than 1 swollen and tender joint, was achieved with UPA, with or without MTX, across patient populations ranging from MTX-naïve to biologic disease-modifying antirheumatic drug (bDMARD) inadequate responders.1-13 Note that clinical remission does not mean drug-free remission or complete absence of disease activity. UPA is not indicated for MTX-naïve patients and the use of UPA in combination with other JAK inhibitors, bDMARDs, or with potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.1

Provided here is an update on the longer-term safety profile of UPA, drawing on the integrated analysis of up to ~3.5 years of exposure data from 5 Phase 3 studies. Analysis of data from the active-comparator controlled study with ADA is also presented. All analyses are based on data with a cutoff date of June 30, 2019.14

Throughout the piece, you’ll find short audio commentaries that provide additional context and information regarding some of the adverse events (AEs) of special interest. Make sure to click on these to hear what Dr. Kevin Winthrop and Dr. Jack Cush have to say.

Safety Profile Cropped

Dr Kevin Winthrop

Listen as Dr. Winthrop discusses serious infections in patients with RA treated with UPA. 

Audio file

Long Term Safety Data on AEs of Special Interest

Dr Jack Cush Headshot

Dr. Cush provides additional information on VTE events in the UPA clinical trials.

Audio file

Risk Ratios for AEs of Special Interest in SELECT-COMPARE

Dr Kevin Winthrop

Click to listen to Dr. Winthrop’s thoughts on UPA and the risk for herpes zoster.

Audio file

Rates of AEs of Special Interest in the Integrated Analysis of the Phase 3 Data of UPA With Up to ~3.5 Years of Exposure

Additional Considerations Prior to Starting Treatment With Upadacitinib:

  • Ensure vaccinations, including herpes zoster, are up to date.
  • Test for latent tuberculosis.
  • Verify pregnancy status.
  • Consider risks and benefits in patients with chronic or recurrent infection.
  • Consider risks and benefits in patients with a known malignancy.
  • Consider risks and benefits in patients with an increased risk of thrombosis.


Serious Infections:

  • Patients treated with RINVOQTM (upadacitinib) are at increased risk for developing serious infections that may lead to hospitalization or death.
  • These infections include tuberculosis (TB), invasive fungal, bacterial, viral, and other infections due to opportunistic pathogens.
  • Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids.


  • Lymphoma and other malignancies have been observed in RINVOQTM (upadacitinib)-treated patients.


  • Thrombosis, including deep vein thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions.

Other Serious Adverse Reactions:

  • Patients treated with RINVOQTM (upadacitinib) also may be at risk for other serious adverse reactions, including gastrointestinal perforations, neutropenia, lymphopenia, anemia, lipid elevations, liver enzyme elevations, and embryo-fetal toxicity.


  • Avoid use of RINVOQTM (upadacitinib) with live vaccines.

Common Adverse Reactions:

  • The most common adverse reactions (≥1%) in patients treated with RINVOQTM (upadacitinib) were upper respiratory tract infections, nausea, cough, and pyrexia.

Review accompanying RINVOQTM (upadacitinib) and HUMIRA® (adalimumab) full Prescribing Information for additional information, visit or contact AbbVie Medical Information at 1-800-633-9110.


  1. RINVOQTM (upadacitinib) [package insert]. North Chicago, IL: AbbVie Inc.; 2019.
  2. Fleischmann R, et al. Arthritis Rheumatol. 2019;71(11):1788-1800.
  3. Van Vollenhoven R, et al. Oral Presentation 891. ACR 2018; October 19-24, 2018.
  4. Smolen JS, et al. Lancet. 2019;393(10188):2303-2311.
  5. Burmester GR, et al. Lancet. 2018;391(10139):2503-2512.
  6. Genovese MC, et al. Lancet. 2018;391(10139):2513-2524.
  7. Data on File. AbbVie. ABVRRTI68885.
  8. Hall S, et al. Poster THU0174. EULAR 2019; June 12-15, 2019.
  9. Fleischmann R, et al. Ann Rheum Dis. 2019;78(11):1454-1462.
  10. Van Vollenhoven R, et al. Poster THU0197. EULAR 2019; June 12-15, 2019.
  11. Smolen JS, et al. Poster THU0191. EULAR 2019; June 12-15, 2019.
  12. Burmester GR, et al. Poster FRI0132. EULAR 2019; June 12-15, 2019.
  13. Genovese M, et al. Poster THU0172. EULAR 2019; June 12-15, 2019.
  14. Cohen SB, et al. Poster THU0197. EULAR 2020 e-Congress; June 3, 2020.
  15. Data on File. AbbVie. ABVRRTI70199.
  16. Winthrop K, et al. Poster FRI0141. EULAR 2020 e-Congress; June 3, 2020.
  17. Winthrop K, et al. Poster THU0218. EULAR 2020 e-Congress; June 3, 2020.
  18. Data on File. AbbVie. ABVRRTI70151.
  19. Data on File. AbbVie. ABVRRTI70193.
  20. Choy E, et al. Poster THU0195. EULAR 2020 e-Congress; June 3, 2020.
  21. Data on File. AbbVie. ABVRRTI70200.
  22. Data on File. AbbVie. ABVRRTI70591.
  23. Data on File. AbbVie. ABVRRTI69047.

Content developed by AbbVie Inc. This content is intended for US/PR Health Care Professionals. The US Medical Affairs department of AbbVie Inc. is the copyright owner of this presentation and has paid RheumNow to host this content.

Dr. Winthrop and Dr. Cush are authors of EULAR 2020 e-Congress scientific posters from which data in this presentation were drawn. Dr. Winthrop and Dr. Cush have received compensation from the US Medical Affairs department of AbbVie Inc. to prepare and present this information and are speaking on behalf of AbbVie.

AbbVie is solely responsible for all written and oral content within this presentation © [2020] AbbVie Inc. All rights reserved.