June 1, 2020: “AbbVie, a research-based global biopharmaceutical company, today announced that it has submitted applications for a new indication to the U.S. FDA and European Medicines Agency (EMA) for RINVOQ™ (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor, for the treatment of adult patients with active psoriatic arthritis.
“Psoriatic arthritis is a complex heterogeneous disease with manifestations across multiple domains, including joints and skin, causing daily pain, fatigue and stiffness,” said Michael Severino, M.D., vice chairman and president, AbbVie.
“We look forward to working with regulatory authorities and hope to bring RINVOQ to people living with this debilitating disease as quickly as possible.”
The applications are supported by data from two Phase 3 studies across a broad range of more than 2,000 patients with active psoriatic arthritis.
In both studies, RINVOQ met the primary endpoint of ACR20 response at week 12 versus placebo.
RINVOQ 15 mg also achieved non-inferiority versus adalimumab in terms of ACR20 response at week 12.
Patients receiving RINVOQ also experienced greater improvements in physical function (HAQ-DI) and skin symptoms (PASI 75), and a greater proportion achieved minimal disease activity.
Overall, the safety profile of RINVOQ in psoriatic arthritis was consistent with previously reported results across the Phase 3 rheumatoid arthritis clinical trial program, with no new significant safety risks detected.1-3
*Physical function was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). Skin symptoms were measured by a 75 percent improvement in the Psoriasis Area Severity Index (PASI 75).
Minimal disease activity is defined as the fulfillment of five of seven outcome measures: Tender joint count ≤1; swollen joint count ≤1; PASI ≤1 or body surface area-psoriasis ≤3 percent; Patient’s Assessment of Pain Numerical Rating Scale (NRS) ≤1.5; Patient Global Assessment-Disease Activity NRS ≤2.0; HAQ-DI score ≤0.5; and Leeds Enthesitis Index ≤1.
RINVOQ™ (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.
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.
In December 2019, RINVOQ was approved by the European Commission for the treatment of adult patients with moderate to severely active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs.
The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis, Crohn’s disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing.
Use of RINVOQ in psoriatic arthritis is not approved and its safety and efficacy have not been established by regulatory authorities.
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
- 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.”
https://news.abbvie.com/news/press-releases/abbvie-submits-regulatory-applications-to-fda-and-ema-for-rinvoq-upadacitinib-for-treatment-adults-with-active-psoriatic-arthritis.htm
