New Long-Term Efficacy and Safety Analyses Evaluating RINVOQ? (upadacitinib) in Patients with Rheumatoid Arthritis to be Presented at EULAR 2021 Virtual Congress
Efficacy Results from SELECT-COMPARE at 3 Years*,1 |
||
RINVOQ 15 mg plus MTX |
HUMIRA 40 mg EOW plus |
|
Clinical remission per DAS28-CRP<2.6a |
32% |
22% |
Clinical remission per CDAI=2.8b |
24% |
17% |
Low Disease Activity per DAS28-CRP=3.2c |
37% |
26% |
Low Disease Activity per CDAI=10d |
39% |
29% |
* |
Efficacy data reported based on randomized treatment groups. For patients who were rescued or prematurely discontinued, non-responder imputation (NRI) was used for binary endpoints. Patients who received HUMIRA were switched to receive RINVOQ 15 mg, and vice versa, if they did not achieve at least a 20 percent improvement in both tender and swollen joint count at weeks 14, 18 or 22 compared to baseline, or if Clinical Disease Activity Index (CDAI) was greater than 10 at week 26. |
a |
Clinical remission per DAS28-CRP is defined as Disease Activity Score with 28 joint counts C-reactive protein (DAS28-CRP) less than 2.6. |
b |
Clinical remission per CDAI is defined as CDAI less than or equal to 2.8. |
c |
Low Disease Activity per DAS28-CRP is defined as Disease Activity Score with 28 joint counts C-reactive protein (DAS28-CRP) less than or equal to 3.2. |
d |
Low Disease Activity per CDAI is defined as CDAI less than or equal to 10. |
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- Fleischmann R., et al. Long-Term Safety and Effectiveness of Upadacitinib or Adalimumab in Patients with Rheumatoid Arthritis: Results at 72 weeks from the SELECT-COMPARE Study. 2020 EULAR E-Congress; THU0201.
- Fleischmann, R., et al. Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double-Blind, Randomized Controlled Trial. Arthritis Rheumatol. 2019 Nov;71(11):1788-1800. doi: 10.1002/art.41032.
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- AbbVie. Data on File, ABVRRTI64959.
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- American College of Rheumatology. "Rheumatoid Arthritis." 2021. Available at:?https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Rheumatoid-Arthritis. Accessed?April 11, 2021.
- World Health Organization. The Global Burden of Disease, 2004 Update. Available at:?http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf. Accessed on?April 11, 2021.
- Singh et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care & Research. 2015;10;1-25.
- Ajeganova S. and Huizinga T. Sustained remission in rheumatoid arthritis: latest evidence and clinical considerations. Ther Adv Musculoskelet Dis. 2017 Oct;9(10):249-262. doi: 10.1177/1759720X17720366.
- A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE). ClincialTrials.gov. 2021. Available at:?https://clinicaltrials.gov/ct2/show/NCT02629159. Accessed on?
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