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AbbVie announced results from new post-hoc analyses from the Phase 3 SELECT-PsA 1 and SELECT-PsA 2 trials assessing the efficacy of upadacitinib (RINVOQ®) on axial symptoms in adult patients with active psoriatic arthritis (PsA) and axial involvement. The analysis showed that patients with active PsA demonstrated numerically greater clinical responses related to their axial involvement with upadacitinib (15 mg, once daily) compared to placebo at week 24 across both studies and consistently numerically higher responses compared to HUMIRA® (adalimumab) at week 24 in SELECT-PsA 1.
Axial involvement was defined by investigator assessment and patient-reported-outcome-based criteria (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 and BASDAI Question 2 ≥4 at baseline).1 These results will be featured at the American College of Rheumatology (ACR) Convergence 2021, in an oral presentation on Tuesday, Nov. 9, from 3:30-3:45 p.m. CT (Abstract #1945).
"These data further add to the body of evidence that supports the potential of upadacitinib to be an important treatment option that helps reduce the impact of the many disease manifestations of psoriatic arthritis," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "We remain committed to advancing research across our portfolio of therapies to help improve care for more people living with rheumatic diseases, including psoriatic arthritis."
At week 24, upadacitinib showed numerically greater responses than adalimumab across all BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS) endpoints in SELECT-PsA 1.1 The proportion of patients achieving ASDAS clinically important improvement (CII) at week 24 was greater with upadacitinib (69.8%) versus adalimumab (54.1%, nominal P<0.05).
Findings from the post-hoc analysis are consistent with previous data based on investigator assessment alone.
Across SELECT-PsA 1 and SELECT-PsA 2 studies, the published safety profile of RINVOQ was consistent with that observed in previously reported studies, with no new safety risks detected.
As previously reported, in SELECT-PsA 1, through week 24, serious infections occurred in 1.2% of patients in the 15 mg RINVOQ group compared to 0.9% in the placebo group and 0.7% in the HUMIRA group.2 There were no cases of adjudicated venous thromboembolic events (VTE) in the RINVOQ 15 mg group, two cases in the adalimumab group (0.5%), and one case in the placebo group (0.2%).2 No major adverse cardiovascular events (MACE) were reported in the RINVOQ 15 mg group.2 There was one MACE reported in the placebo group and two MACE reported in the HUMIRA group.2 Herpes zoster was reported in four cases in the 15 mg RINVOQ group (0.9%), three cases in the placebo group (0.7%), and no cases in the HUMIRA group.5 There were no deaths in the RINVOQ 15 mg group, one death in the placebo group (0.2%), and no deaths in the adalimumab group.
As previously reported, for the SELECT-PsA 2 study, through week 24, serious infections occurred in 0.5% of patients in the RINVOQ 15 mg group compared to 0.5% in the placebo group.4 There was one pulmonary embolism reported in the 15 mg RINVOQ group and none in the placebo group.4 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 placebo group.4 Herpes zoster was reported in three cases in the 15 mg RINVOQ group (1.4%) and in two cases in the placebo group (0.9%).6 One death was reported in a patient receiving a placebo (motor vehicle accident).
The use of upadacitinib in psoriatic arthritis is not approved in the U.S. and its safety and efficacy are currently under review by the U.S. Food and Drug Administration (FDA).
The ACR Convergence 2021 abstracts can be found here.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin.7 In PsA, the immune system causes inflammation that can lead to skin lesions associated with psoriasis, pain, fatigue and stiffness in the joints.7,8 PsA affects about 30 percent of people with psoriasis.9,10
About SELECT-PsA 111,12
SELECT-PsA 1 is a Phase 3, multicenter, randomized, double-blind, active comparator- and placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ compared to placebo and adalimumab in adult patients with moderately to severely active psoriatic arthritis who have a history of intolerance or inadequate response to at least one non-biologic DMARD. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg, adalimumab 40 mg every other week or placebo followed by either RINVOQ 15 mg or RINVOQ 30 mg at week 24.
The primary endpoint was the percentage of subjects receiving RINVOQ 15 mg or 30 mg who achieved an ACR20 response after 12 weeks of treatment versus placebo. The long-term extension of the trial is ongoing. More information on this trial can be found at www.clinicaltrials.gov (NCT03104400).
About SELECT-PsA 211,13
SELECT-PsA 2 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult patients with moderately to severely active psoriatic arthritis who have a history of intolerance or inadequate response to at least one biologic DMARD. 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 versus placebo. The long-term extension of the trial is ongoing. More information on this trial can be found at www.clinicaltrials.gov (NCT03104374).
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.11 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known. RINVOQ 15 mg is approved by the U.S. Food and Drug Administration (FDA) for adults with moderately to severely active rheumatoid arthritis. RINVOQ 15 mg is also approved by the European Commission for adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis and adults with active ankylosing spondylitis. RINVOQ is approved by the European Commission for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.14-21
Important Safety Information about RINVOQ® (upadacitinib)11
RINVOQ U.S. Use and Important Safety Information
RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.
What is the most important information I should know about RINVOQ?
RINVOQ is a medicine that can lower the ability of your immune system to fight infections. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay.
What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:
Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.
Especially tell your HCP if you take:
Ask your HCP or pharmacist if you are not sure if you are taking any of these medicines.
What should I tell my HCP AFTER starting RINVOQ?
Tell your HCP right away if you:
What are the common side effects of RINVOQ?
These include: upper respiratory tract infections (common cold, sinus infections), nausea, cough, and fever. These are not all the possible side effects of RINVOQ.
RINVOQ is taken once a day with or without food. Do not split, break, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it.
This is the most important information to know about RINVOQ. For more information, talk to your HCP.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.
Please click here for the Full Prescribing Information and Medication Guide.
Globally, prescribing information varies; refer to the individual country product label for complete information.
About HUMIRA (adalimumab) in the U.S.
Uses
HUMIRA is a prescription medicine used:
Important Safety Information About HUMIRA® (adalimumab)
What is the most important information I should know about HUMIRA?
You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.
What should I tell my doctor BEFORE starting HUMIRA?
Tell your doctor about all of your health conditions, including if you:
Also tell your doctor about all the medicines you take. You should not take HUMIRA with ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab). Tell your doctor if you have ever used RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (mercaptopurine, 6-MP)b®
What should I watch for AFTER starting HUMIRA?
HUMIRA can cause serious side effects, including:
Call your doctor or get medical care right away if you develop any of the above symptoms.
Common side effects of HUMIRA include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.
Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:
HUMIRA is given by injection under the skin.
This is the most important information to know about HUMIRA. For more information, talk to your health care provider.
Please click here for the Full Prescribing Information and Medication Guide.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.
Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie in Rheumatology
For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals. For more information on AbbVie in rheumatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.html.
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