New England Journal of Medicine Publishes 24-Week Results from Phase 3 Study Evaluating RINVOQ™ (upadacitinib) in Psoriatic Arthritis

NORTH CHICAGO, Ill., April 1, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the New England Journal of Medicine has published 24-week results from the Phase 3 SELECT-PsA 1 trial evaluating RINVOQ^™ (upadacitinib, 15 mg and 30 mg) in adults with active psoriatic arthritis who had responded inadequately or were intolerant to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs).¹ These data build on previously announced Phase 3 topline results showing that upadacitinib 15 mg and 30 mg met the primary endpoint of ACR20 response at week 12 versus placebo as well as key secondary endpoints.¹ 

"These data show upadacitinib's potential to improve clinical and radiographic outcomes for people with psoriatic arthritis, a complex and progressive autoimmune disease," said Thomas Hudson, MD, senior vice president, research and development, chief scientific officer, AbbVie. "Ultimately, our goal is to help more patients achieve disease control and relief from their most bothersome joint and skin symptoms that can impact their daily lives."

Recently, the European Commission (EC) approved RINVOQ (15 mg) for use in adults with active psoriatic arthritis. Use of RINVOQ in psoriatic arthritis is not approved and its safety and efficacy are under evaluation by regulatory authorities in the United States.

Efficacy results for ranked secondary endpoints not previously reported include:^1*

• A significantly higher percentage of patients taking upadacitinib 15 mg and 30 mg (54 and 58 percent, respectively) achieved resolution of enthesitis (Leeds Enthesitis Index (LEI)=0) compared to those taking placebo (32 percent) at week 24 (p<0.001 for both doses); 47 percent of patients achieved resolution of enthesitis in the adalimumab group.
• Patients taking upadacitinib 15 mg and 30 mg (6.3 and 7.1 mean change from baseline, respectively) saw an improvement in fatigue compared to patients taking placebo (2.8) at week 12 (p<0.001 for both doses), as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, which continued to improve through week 24; patients in the adalimumab group saw an improvement (5.7) at week 12.
• At week 16, significantly more patients achieved a score of 0 or 1 and at least a 2-point improvement in the static Investigator Global Assessment of psoriasis (sIGA) with the 15 mg and 30 mg doses of upadacitinib (42 and 54 percent, respectively) versus placebo (11 percent, p<0.001 for both doses); 39 percent of patients in the adalimumab group.
• Inhibition of radiographic progression, as measured by the modified total Sharp/van der Heijde Score (mTSS) at week 24, was observed with both doses of upadacitinib (-0.04 for the 15 mg dose, p<0.001, and 0.03 for the 30 mg dose, p=0.007), compared to placebo, which showed an increase of 0.25; 0.01 was observed in the adalimumab group.
• At week 24, 77 percent and 80 percent of patients taking 15 mg and 30 mg of upadacitinib, respectively, achieved resolution of dactylitis (Leeds Dactylitis Index (LDI)=0) compared to 40 percent of patients taking placebo (nominal p-values <0.001; comparison not multiplicity controlled); 74 percent of patients achieved resolution of dactylitis in the adalimumab group.

* Comparison to adalimumab for these endpoints was not multiplicity-controlled.

"Psoriatic arthritis is a chronic, painful autoimmune disease," said Iain McInnes, Professor of Medicine and Versus Arthritis Professor of Rheumatology at University of Glasgow, UK, and the lead study author. "I am encouraged by these results showing that upadacitinib can improve outcomes for people living with psoriatic arthritis who are facing the potentially debilitating impact of joint and skin symptoms, along with other debilitating challenges like fatigue."

The safety profile of upadacitinib was generally similar to results reported previously in rheumatoid arthritis trials.^1,2 Through 24 weeks, rates of treatment-emergent adverse events (AEs) and serious AEs were similar between 15 mg of upadacitinib and 40 mg of adalimumab, but were more frequent with upadacitinib 30 mg. The most common AE was upper respiratory tract infection. Rates of serious infections were 0.9 percent (placebo), 0.7 percent (adalimumab), 1.2 percent (upadacitinib 15 mg) and 2.6 percent (upadacitinib 30 mg). Herpes zoster were reported in three (0.7 percent), zero, four (0.9 percent) and five (1.2 percent) cases for the placebo, adalimumab, upadacitinib 15 mg and upadacitinib 30 mg arms, respectively. Malignancy was reported in all treatment arms with one case in the placebo and upadacitinib 15 mg arms (0.2 percent) and three cases in the adalimumab and upadacitinib 30 mg arms (0.7 percent).

Adjudicated venous thrombotic events included one event of deep vein thrombosis in the placebo group (0.2 percent), two events of deep vein thrombosis in the adalimumab group (0.5 percent), and one event of pulmonary embolism in the upadacitinib 30 mg group (0.2 percent); no thrombotic events were reported in the upadacitinib 15 mg group. No major adverse cardiovascular events (MACE) and deaths were reported with upadacitinib treatment.¹ 

About SELECT-PsA 1^1,3
SELECT-PsA 1 is a Phase 3, multicenter, randomized, double-blind, parallel-group, active and placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib compared to placebo and adalimumab in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one non-biologic DMARD. Patients were randomized to upadacitinib 15 mg, upadacitinib 30 mg, adalimumab 40 mg EOW, or placebo followed by either upadacitinib 15 mg or upadacitinib 30 mg at week 24.

The primary endpoint was the percentage of subjects receiving upadacitinib 15 mg or 30 mg who achieved an ACR20 response after 12 weeks of treatment versus placebo. Ranked secondary endpoints included percentage of patients achieving a static Investigator Global Assessment (sIGA) of psoriasis of 0 or 1 and at least a 2-point improvement from baseline at week 16; percentage of patients achieving PASI 75 response at week 16; inhibition of radiographic progression at week 24 per the modified total Sharp/van der Heijde Score; the percentage of patients achieving MDA at week 24; percentage of participants with resolution of enthesitis at week 24; change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire at week 12; and percentage of patients with resolution of dactylitis at week 24 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 RINVOQ™ (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.^2-12 In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs; for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs; and for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. 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.^2-5,7-12 Use of RINVOQ in psoriatic arthritis is not approved and its safety and efficacy are under evaluation by regulatory authorities.

RINVOQ U.S. Use and Important Safety Information¹³
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.

• Serious infections have happened in some people taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your HCP should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You may be at higher risk of developing shingles (herpes zoster).
• Lymphoma and other cancers, including skin cancers, can happen in people taking RINVOQ.
• Blood clots in the veins of the legs or lungs and arteries are possible in some people taking RINVOQ. This may be life-threatening and cause death.
• Tears in the stomach or intestines and changes in certain laboratory tests can happen. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.

What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:

• Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection such as:
• Fever, sweating, or chills
• Shortness of breath
• Warm, red, or painful skin or sores on your body
• Muscle aches
• Feeling tired
• Blood in phlegm
• Diarrhea or stomach pain
• Cough
• Weight loss
• Burning when urinating or urinating more often than normal
• Have TB or have been in close contact with someone with TB.
• Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), or blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
• Have other medical conditions including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
• Live, have lived, or have traveled to parts of the country that increase your risk of getting certain kinds of fungal infections, such as the Ohio and Mississippi River valleys and the Southwest. If you are unsure if you've been to these areas, ask your HCP.
• Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
• Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant while taking RINVOQ and for at least 4 weeks after your last dose.
• Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. You should not breastfeed while taking RINVOQ and for at least 6 days after your last dose.

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:

• Medicines for fungal or bacterial infections
• Rifampicin or phenytoin
• Medicines that affect your immune system

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:

• Have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.
• Have any signs or symptoms of blood clots during treatment with RINVOQ, including:
• Swelling
• Sudden unexplained chest pain
• Pain or tenderness in the leg
• Shortness of breath
• Have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

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.

Uses¹⁴
HUMIRA is a prescription medicine used:

• To reduce the signs and symptoms of:
• Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
• Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
• Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
• Ankylosing spondylitis (AS) in adults.
• Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to certain other medications. HUMIRA is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab.
• Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough.
• Moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.
• In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
• To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
• To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults and children 2 years of age and older.

Important Safety Information
HUMIRA is a TNF blocker medicine that affects the immune system and can lower the body's ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy, even if their TB test was negative. People at risk of TB may be treated with medicine for TB. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, as these infections may happen or become more severe if people use HUMIRA. People should tell their doctor if they have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated.

Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions, including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis. The use of HUMIRA with anakinra or abatacept is not recommended. People using HUMIRA should not receive live vaccines. Children should be brought up to date on all vaccines before starting HUMIRA.

Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea.

HUMIRA is given by injection under the skin.

The benefits and risks of HUMIRA should be carefully considered before starting therapy.

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 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
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References:

1. McInnes I, et al. Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis. New England Journal of Medicine. 2021 April 1;384:1227-1239. doi: 10.1056/NEJMoa2022516.
2. Burmester GR, 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.
3. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT-PsA 1). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on November 30, 2020.
4. 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. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03104374. Accessed on November 30, 2020.
5. A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on November 30, 2020.
6. Pipeline – Our Science | AbbVie. AbbVie. 2019. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on November 30, 2020.
7. 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. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on November 30, 2020.
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. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on November 30, 2020.
9. A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed on November 30, 2020.
10. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed on November 30, 2020.
11. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on November 30, 2020.
12. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-TAK). ClinicalTrials.gov. 2020. Available at https://clinicaltrials.gov/ct2/show/record/NCT04161898. Accessed on November 30, 2020.
13. RINVOQ™ (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
14. HUMIRA Injection [Package Insert]. North Chicago, Ill.: AbbVie Inc.

SOURCE AbbVie

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