RINVOQ (upadacitinib) Meets Primary and All Ranked Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis
- 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]
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. |
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.
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.
- Medicines for fungal or bacterial infections
- Rifampicin or phenytoin
- Medicines that affect your immune system
- 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.
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?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. 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. References:
- AbbVie Data on File. ABVRRTI69484.
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- 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.
- 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.