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

NORTH CHICAGO, Ill., Feb. 5, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-PsA 1 clinical trial. In this study, both doses of RINVOQ^TM (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 or are intolerant to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs).¹ RINVOQ also demonstrated significant improvements in signs and symptoms of the disease across a variety of endpoints compared to placebo.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 inflammatory diseases.^1,3-10

"Patients living with psoriatic arthritis often suffer from joint pain, stiffness and fatigue, impacting their ability to work and lead a physically active life," said Michael Severino, M.D., vice chairman and president, AbbVie. "The results of this large Phase 3 study further support the potential of RINVOQ to help these patients. We look forward to sharing these data with regulatory bodies around the world to support our application for label expansion for RINVOQ to include adult patients with active psoriatic arthritis."

Results show that at week 12, 71 percent and 79 percent of patients receiving 15 mg and 30 mg of RINVOQ achieved ACR20, respectively, compared to 36 percent of patients receiving placebo (p<0.0001).¹ In terms of ACR20 response at week 12 versus adalimumab, both RINVOQ doses achieved non-inferiority and only the 30 mg dose showed superiority.¹ ACR50 at week 12 was achieved by 38 percent and 52 percent of patients receiving 15 mg and 30 mg of RINVOQ, respectively, compared to 13 percent of patients receiving placebo (nominal p<0.0001).¹ In addition, 16 percent and 25 percent of patients receiving 15 mg and 30 mg of RINVOQ achieved ACR70, respectively, at week 12 compared to 2 percent of the placebo group (nominal 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).¹ Patients in the 15 mg and 30 mg RINVOQ groups reported a -0.42 and -0.47 change from baseline in HAQ-DI score, respectively, compared to -0.14 on placebo (p<0.0001).¹ RINVOQ also showed improvement in skin symptoms at week 16, with 63 percent and 62 percent of patients receiving 15 mg and 30 mg of RINVOQ achieving a 75 percent improvement in the Psoriasis Area Severity Index (PASI 75), respectively, compared to 21 percent on placebo (p<0.0001).¹ Minimal disease activity (MDA) at week 24 was achieved in 37 percent and 45 percent of 15 mg and 30 mg RINVOQ-treated patients, respectively, versus 12 percent of the placebo group (p<0.0001).¹

"The results of SELECT-PsA 1 showed that both doses of upadacitinib demonstrated significantly greater efficacy in joint and skin symptoms, as well as inhibition of radiographic progression, compared to placebo," said Professor Iain McInnes, F.R.C.P., Ph.D., University of Glasgow Institute of Infection, Immunity & Inflammation. "These data are encouraging and add to the growing body of evidence that upadacitinib has the potential to improve outcomes for people living with psoriatic arthritis."

Following 24 weeks of treatment, RINVOQ at 15 mg and 30 mg significantly inhibited radiographic progression, as measured by the change from baseline in modified PsA Sharp/van der Heijde Score, compared to placebo (p<0.01).¹ The inhibition of joint damage is important for psoriatic arthritis patients as this can impact physical function and disability.¹¹

The safety profile of RINVOQ was consistent with that observed in previously reported studies, with no new safety risks detected.¹ Through week 24, serious infections occurred in 1.2 percent and 2.6 percent of patients in the 15 mg and 30 mg RINVOQ groups, respectively, compared to 0.9 percent in the placebo group and 0.7 percent in the adalimumab group.¹ There was one case of adjudicated venous thromboembolic events (VTE) in the RINVOQ 30 mg group (0.2 percent), no cases in the RINVOQ 15 mg group, two cases in the adalimumab group (0.5 percent) and one case in the placebo group (0.2 percent).¹ No major adverse cardiovascular events (MACE) were reported in either RINVOQ group.¹ There was one MACE reported in the placebo group and two MACE reported in the adalimumab group.¹ There were no deaths in either RINVOQ group, one death in the placebo group (0.2 percent) and no deaths in the adalimumab group.¹

Psoriatic arthritis is a heterogeneous systemic inflammatory disease with hallmark manifestations in joints and skin, affecting more than 50 million people worldwide.^12,13 In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue and stiffness in the joints.¹²

Results from the SELECT-PsA 1 study will be presented at a future medical meeting and published in a peer-reviewed publication.

About SELECT-PsA 1^1,14

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 RINVOQ 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 RINVOQ 15 mg, RINVOQ 30 mg, adalimumab (40 mg EOW) 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. Ranked secondary endpoints included change from baseline in HAQ-DI at week 12, proportion of patients achieving PASI 75 at week 16 and 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 (NCT03104400).

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 In August 2019, RINVOQ received U.S. Food and Drug Administration approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, RINVOQ also received approval 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. Phase 3 trials of RINVOQ in rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing.^1,6-10

Important Safety Information about RINVOQ™ (upadacitinib)

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.

• 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
• Pain or tenderness in the leg
• Sudden unexplained chest pain
• 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.

Please click here for the Full Prescribing Information and Medication Guide.

This is the most important information to know about RINVOQ. For more information, talk to your HCP.

Important Safety Information about HUMIRA™ (adalimumab)

HUMIRA U.S. Use and Important Safety Information
HUMIRA is a prescription medicine used alone or with certain other medicines to reduce the signs and symptoms of psoriatic arthritis in adults, may prevent further damage to your bones and joints, and may help your ability to perform daily activities.

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. 

This is the most important information to know about HUMIRA. For more information, talk to your HCP.

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.

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.

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, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 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 2018 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. 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.

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