RINVOQ™ (upadacitinib) Meets Primary and All Ranked Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis

– Positive top-line study results show that both doses of RINVOQ™ (upadacitinib; 15 mg and 30 mg, once daily) met the primary endpoint of ACR20 response in adult patients with active psoriatic arthritis who had an inadequate response to other bDMARDs at week 12 versus placebo[1]

– At week 12, 57/64 percent of patients receiving 15/30 mg of RINVOQ achieved ACR20, respectively, compared to 24 percent in the placebo group[1]

– At week 16, 52/57 percent of patients on 15/30 mg of RINVOQ achieved a PASI 75 response, respectively, compared to 16 percent on placebo[1]

– At week 24, 25/29 percent of 15/30 mg RINVOQ-treated patients achieved minimal disease activity, respectively, compared to 3 percent in the placebo group[1]

– The safety profile of RINVOQ was consistent with that of previous studies across indications, with no new safety risks detected[1,2]

NORTH CHICAGO, IL, USA I October 31, 2019 I AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line data from the SELECT-PsA 2 Phase 3 study. In this study, both doses of RINVOQ™ (upadacitinib; 15 mg and 30 mg, once daily) met the primary endpoint of ACR20 response at week 12 versus placebo in adult patients with active psoriatic arthritis who have responded inadequately to one or more biologic disease modifying anti-rheumatic drugs (bDMARDs).¹ In addition, patients on both doses of RINVOQ achieved significantly greater responses compared to placebo for all ranked secondary endpoints.¹ SELECT-PsA 2 is the first study evaluating the efficacy and safety of RINVOQ in adult patients with active psoriatic arthritis.¹ RINVOQ, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is being studied as a once-daily therapy in psoriatic arthritis and multiple immune-mediated diseases^1,3-10

“Too many people living with psoriatic arthritis still fail to achieve their treatment goals, underscoring a clear medical need for additional therapeutic options,” said Michael Severino, M.D., vice chairman and president, AbbVie. “We are pleased with these data, which show the potential of RINVOQ to improve outcomes for people with psoriatic arthritis across a variety of symptoms. Data from this Phase 3 study will support regulatory submissions for RINVOQ in psoriatic arthritis.”

Results show that at week 12, 57/64 percent of patients receiving 15/30 mg of RINVOQ achieved ACR20, respectively, compared to 24 percent in the placebo group (p<0.0001).¹ Additionally, ACR50 was achieved by 32/38 percent of patients receiving 15/30 mg of RINVOQ, respectively, compared to 5 percent on placebo at week 12 (p<0.0001).¹ 9/17 percent of patients achieved ACR70 in the 15/30 mg RINVOQ groups, respectively, compared to 0.5 percent in the placebo group at week 12 (p<0.0001).¹ Patients receiving RINVOQ also had greater improvements in physical function at week 12, as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). RINVOQ showed improvement in skin symptoms at week 16, with 52/57 percent of patients receiving 15/30 mg of RINVOQ achieving a 75 percent improvement in the Psoriasis Area Severity Index (PASI 75), respectively, compared to 16 percent on placebo (p<0.0001).¹ 25/29 percent of 15/30 mg RINVOQ-treated patients achieved minimal disease activity (MDA) at week 24 (p<0.0001), respectively, compared to 3 percent in the placebo group.¹

SELECT-PsA 2 Efficacy Results1,†
	RINVOQ 15 mg (n=211)	RINVOQ 30 mg (n=218)	Placebo (n=212)
ACR20a at week 12	57%	64%	24%
ACR50a at week 12	32%	38%	5%
ACR70a at week 12	9%	17%	0.5%
HAQ-DIb at week 12	-0.30	-0.41	-0.10
PASI 75c at week 16	52%	57%	16%
MDAd at week 24	25%	29%	3%
†Primary endpoint was ACR20 at week 12. All reported endpoints achieved p-values of <0.0001 versus placebo for both doses. Not all ranked secondary endpoints shown.
aACR20/50/70 is defined as at least a 20 percent/50 percent/70 percent reduction from baseline in the number of both tender and swollen joint counts and equivalent improvement in three or more of the five remaining American College of Rheumatology core set measures: patient assessments of pain, global disease activity, physical function, physician global assessment of disease activity and acute phase reactant.
b HAQ-DI is defined as change in baseline in the Health Assessment Questionnaire Disability Index, which is a is a patient-reported questionnaire including categories of dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. It asks patients about the amount of difficulty they experience in these activities as well as the use of aids and/or devices.
c PASI 75 is defined as a 75 percent improvement in the Psoriasis Area Severity Index. It was assessed in patients with ≥3 percent body surface area (BSA) psoriasis at baseline.
d MDA is defined as the fulfillment of 5 of 7 outcome measures: TJC ≤1; SJC ≤1; PASI ≤1 or BSA-Ps ≤3 percent; Patient’s Assessment of Pain NRS ≤1.5; PtGA-Disease Activity NRS ≤2.0; HAQ-DI score ≤0.5; and LEI (Leeds Enthesitis Index) ≤1.

In this study, the safety profile of RINVOQ was consistent with that observed in previously reported studies in patients with rheumatoid arthritis, with no new safety risks detected.^1,2 Through week 24, serious infections occurred in 0.5/2.8 percent of patients in the 15/30 mg RINVOQ groups, respectively, compared to 0.5 percent in the placebo group.¹ There was one pulmonary embolism reported in the 15 mg RINVOQ group and none in the 30 mg and placebo groups. There was one non-fatal adjudicated major adverse cardiovascular event (MACE) in the 15 mg RINVOQ group (acute myocardial infarction) and no MACE in the 30 mg and placebo groups. One death was reported in a patient receiving placebo (motor vehicle accident).

Psoriatic arthritis is a heterogeneous systemic inflammatory disease with hallmark manifestations in joints and skin, affecting more than 50 million people worldwide.^11,12 In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue and stiffness in the joints.¹¹ 

Full results from the SELECT-PsA 2 study will be presented at a future medical meeting and published in a peer-reviewed publication.

About SELECT-PsA 2^1,13

SELECT-PsA 2 is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one bDMARD. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg or placebo followed by either RINVOQ 15 mg or RINVOQ 30 mg at week 24.

The primary endpoint was the percentage of subjects achieving an ACR20 response after 12 weeks of treatment. Secondary endpoints included change from baseline in HAQ-DI, proportion of patients achieving ACR50 and ACR70 at week 12, proportion of patients achieving PASI 75 at week 16, as well as proportion of patients achieving MDA at week 24. The trial is ongoing, and the long-term extension remains blinded to evaluate the long-term safety, tolerability and efficacy of the two once-daily doses (15 mg and 30 mg) of RINVOQ in patients who have completed the placebo-controlled period. More information on this trial can be found at www.clinicaltrials.gov (NCT03104374).

About RINVOQ (upadacitinib)

Discovered and developed by AbbVie, RINVOQ is a selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases.^1-10 Earlier this year, RINVOQ received U.S. Food and Drug Administration approval for adult patients with moderately to severely active rheumatoid arthritis. RINVOQ also received a positive opinion from the European Union’s Committee for Medicinal Products for Human Use and is currently awaiting final approval by the European Commission. Phase 3 trials of RINVOQ in psoriatic arthritis, Crohn’s disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing and it is also being investigated to treat ankylosing spondylitis.^1,6-10

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

References:

1. AbbVie Data on File. ABVRRTI69484.
2. Cohen S., et al. Safety profile of upadacitinib in Rheumatoid Arthritis: Integrated analysis from the SELECT Phase 3 Clinical Program. EULAR 2019; THU0167.
3. Bergman M., et al. Upadacitinib Treatment and the Routine Assessment of Patient Index Data 3 (RAPID3) Among Patients with Rheumatoid Arthritis. 2019 ACR/ARHP Annual Meeting; 551.
4. Pipeline – Our Science | AbbVie. AbbVie. 2019. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on September 24, 2019.
5. Burmester G.R., et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
6. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on October 23, 2019.
7. Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)- Measure Up 1. ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03569293. Accessed on October 23, 2019.
8. A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on October 23, 2019.
9. A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on October 23, 2019.
10. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on October 23, 2019.
11. Duarte, G.V., et al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi: 10.1016/j.berh.2012.01.003.
12. International Federation of Psoriasis Associations. Psoriasis is a Serious Disease Deserving Global Attention. Available at: https://ifpa-pso.com/wp-content/uploads/2017/01/Brochure-Psoriasis-is-a-serious-disease-deserving-global-attention.pdf. Accessed October 23, 2019.
13. A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (SELECT-PsA 2). ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03104374. Accessed October 23, 2019.

SOURCE: AbbVie