NORTH CHICAGO, Ailing., Dec. 14, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) right this moment introduced that the U.S. Meals and Drug Administration (FDA) has accepted RINVOQ® (upadacitinib; 15 mg, as soon as each day) for the therapy of adults with energetic psoriatic arthritis (PsA) who’ve had an insufficient response or intolerance to a number of tumor necrosis issue (TNF) blockers.1
“The efficacy of RINVOQ in relieving the various manifestations of psoriatic arthritis is well-characterized in two giant, long run medical research,” mentioned Michael Severino, M.D., vice chairman and president, AbbVie. “This new approval underscores our mission to ship a portfolio of therapies that may assist extra individuals with rheumatic illnesses obtain illness management.”
The FDA approval is supported by knowledge from two pivotal Section 3 trials, SELECT-PsA 1 and SELECT-PsA 2, which assessed the efficacy, security and tolerability of RINVOQ in sufferers with PsA.2,3 In each research, the security profile in sufferers with energetic PsA handled with RINVOQ 15 mg was per the security profile noticed in sufferers with rheumatoid arthritis.
“Many adults nonetheless battle to discover a therapy choice that helps them decrease their illness exercise,” mentioned Iain McInnes, professor of drugs and Versus Arthritis professor of rheumatology at College of Glasgow, U.Ok., and lead investigator of the SELECT-PsA 1 trial. “With this FDA approval, RINVOQ has the potential to assist extra individuals discover significant aid from the indicators and signs of psoriatic arthritis that they see and really feel and to assist attain their therapy objectives.”
Throughout SELECT-PsA 1 and SELECT-PsA 2 Section 3 medical trials, RINVOQ met its major endpoint of ACR20 at week 12 with sufferers taking RINVOQ 15 mg attaining considerably larger ACR20 responses (71% and 57%, respectively) versus placebo (36% and 24%, respectively).2,3
Joint Efficacy1-3
- Throughout each SELECT-PsA 1 and SELECT-PsA 2 Section 3 medical trials, sufferers handled with RINVOQ 15 mg achieved larger ACR50 responses (38% and 32%, respectively) at week 12 in comparison with placebo (13% and 5%, respectively).
- Sufferers handled with RINVOQ 15 mg throughout the SELECT-PsA 1 and SELECT-PsA 2 medical trials achieved larger ACR70 responses (16% and 9%, respectively) in comparison with placebo (2% and 1%, respectively) at week 12.
- Remedy with RINVOQ 15 mg resulted in enchancment in dactylitis and enthesitis in sufferers with pre-existing dactylitis or enthesitis.
- In SELECT-PsA 1, therapy with RINVOQ 15 mg considerably inhibited the development of structural joint harm (-0.02 change from baseline) in comparison with placebo (0.23) as assessed by the change from baseline in modified Whole Sharp Rating (mTSS) at week 24.
Bodily Perform1-3
- Throughout SELECT-PsA 1 and SELECT-PsA 2 medical trials, sufferers handled with RINVOQ 15 mg confirmed vital enchancment in bodily operate from baseline in comparison with placebo as assessed by HAQ-DI at week 12.
Fatigue1-3
- In each Section 3 medical trials, sufferers receiving RINVOQ 15 mg skilled considerably larger enchancment from baseline in fatigue, as measured by the Purposeful Evaluation of Persistent Sickness Remedy – Fatigue (FACIT-F) rating, at Week 12 in comparison with placebo.
Pores and skin Response1-3
- Remedy with RINVOQ 15 mg resulted in enchancment in pores and skin manifestations in sufferers with PsA. Nevertheless, RINVOQ has not been studied in and isn’t indicated for the therapy of plaque psoriasis.
Security1-3
- Total, the security profile noticed in sufferers with energetic PsA handled with RINVOQ 15 mg was per the security profile noticed in sufferers with rheumatoid arthritis. Throughout the 24-week placebo-controlled interval, the most typical opposed occasions reported with RINVOQ 15 mg have been higher respiratory tract an infection and blood creatine phosphokinase elevations. The frequencies of herpes zoster and herpes simplex have been 1.1% and 1.4%, respectively, with RINVOQ 15 mg and 0.8% and 1.3%, respectively, with placebo. The next incidence of zits and bronchitis was additionally noticed in sufferers handled with RINVOQ 15 mg (1.3% and three.9%, respectively) in comparison with placebo (0.3% and a pair of.7%, respectively).
- RINVOQ might trigger critical unwanted side effects, together with:
- Critical infections. RINVOQ can decrease your capacity to struggle infections. Critical infections have occurred whereas taking RINVOQ, together with tuberculosis (TB) and infections brought on by micro organism, fungi, or viruses that may unfold all through the physique. Some individuals have died from these infections.
- Elevated danger of demise in individuals 50 years and older with no less than 1 coronary heart illness (cardiovascular) danger issue.
- Most cancers and immune system issues. RINVOQ might enhance your danger of sure cancers, together with lymphoma, pores and skin, and lung most cancers, as these can occur. Present or previous people who smoke are at larger danger.
- Elevated danger of main cardiovascular occasions equivalent to coronary heart assault, stroke, or demise in individuals 50 years and older with no less than 1 coronary heart illness (cardiovascular) danger issue, particularly in present or previous people who smoke.
- Blood clots. Blood clots within the veins of the legs or lungs and arteries can occur with RINVOQ. This can be life-threatening and trigger demise. This has occurred extra typically in individuals 50 years and older with no less than 1 coronary heart illness (cardiovascular) danger issue.
Different critical unwanted side effects embody tears within the abdomen or intestines and modifications in sure laboratory check outcomes.
Ease of Use and Entry
- Designed to assist accommodate the bodily limitations of individuals dwelling with rheumatic illnesses, the packaging for RINVOQ features a bottle cap with a large, easy-to-grip texture and an embedded software that punctures the foil liner to simplify treatment entry. This packaging design was awarded the Arthritis Basis Ease of Use Commendation.4
- AbbVie continues to work intently with key stakeholders to assist affected person entry to RINVOQ, together with providing a affected person assist program and a co-pay card that will cut back out-of-pocket prices to $5 monthly for eligible, commercially-insured sufferers. For these with restricted or no medical insurance, AbbVie gives myAbbVie Help, a affected person help program that gives RINVOQ to qualifying sufferers. For extra particulars, please go to AbbVie.com/myAbbVieAssist.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a heterogeneous, systemic inflammatory illness with hallmark manifestations throughout a number of domains together with joints and pores and skin.5 In PsA, the immune system causes irritation that may result in pores and skin lesions related to psoriasis, ache, fatigue and stiffness within the joints.5,6 PsA impacts about 30% of individuals with psoriasis.7,8
About SELECT-PsA 11,2
SELECT-PsA 1 is a Section 3, multicenter, randomized, double-blind, energetic comparator- and placebo-controlled research designed to judge the security and efficacy of RINVOQ in comparison with placebo and adalimumab in grownup sufferers with reasonably to severely energetic psoriatic arthritis who’ve a historical past of intolerance or insufficient response to no less than one non-biologic DMARD. Sufferers have been randomized to RINVOQ 15 mg, RINVOQ 30 mg, adalimumab 40 mg each different week, or placebo adopted by both RINVOQ 15 mg or RINVOQ 30 mg at week 24.
The first endpoint was the proportion of topics receiving RINVOQ 15 mg or 30 mg who achieved an ACR20 response after 12 weeks of therapy versus placebo. Key secondary endpoints included change from baseline in HAQ-DI at week 12, proportion of sufferers attaining, share of sufferers attaining a static Investigator World Evaluation (sIGA) of psoriasis of 0 or 1 and no less than a 2-point enchancment from baseline at week 16; share of sufferers attaining PASI 75 response at week 16; inhibition of radiographic development at week 24 per the change from baseline in mTSS; the proportion of sufferers attaining MDA at week 24; share of members with decision of enthesitis at week 24; change from baseline in FACIT-F questionnaire at week 12; and share of sufferers with decision of dactylitis at week 24. These are usually not all the secondary endpoints. The long-term extension of the trial is ongoing. Extra data on this trial could be discovered at www.clinicaltrials.gov (NCT03104400).
About SELECT-PsA 21,3
SELECT-PsA 2 is a Section 3, multicenter, randomized, double-blind, placebo-controlled research designed to judge the security and efficacy of RINVOQ in grownup sufferers with reasonably to severely energetic psoriatic arthritis who’ve a historical past of intolerance or insufficient response to no less than one biologic DMARD. Sufferers have been randomized to RINVOQ 15 mg, RINVOQ 30 mg or placebo adopted by both RINVOQ 15 mg or RINVOQ 30 mg at week 24.
The first endpoint was the proportion of topics attaining an ACR20 response after 12 weeks of therapy vs placebo. Key secondary endpoints included change from baseline in HAQ-DI at week 12, proportion of sufferers attaining ACR50 and ACR70 at week 12, proportion of sufferers attaining PASI 75 at week 16, in addition to proportion of sufferers attaining MDA at week 24. These are usually not all the secondary endpoints. The long-term extension of the trial is ongoing. Extra data on this trial could be discovered at www.clinicaltrials.gov (NCT03104374).
About RINVOQ® (upadacitinib)
Found and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that’s being studied in a number of immune-mediated inflammatory illnesses. Primarily based on enzymatic and mobile assays, RINVOQ demonstrated larger inhibitory efficiency for JAK-1 vs JAK-2, JAK-3, and TYK-2.1 The relevance of inhibition of particular JAK enzymes to therapeutic effectiveness and security just isn’t at the moment identified. RINVOQ 15 mg is accepted by the U.S. Meals and Drug Administration (FDA) for adults with reasonably to severely energetic rheumatoid arthritis who’ve had an insufficient response or intolerance to a number of TNF blockers and adults with energetic psoriatic arthritis who’ve had an insufficient response or intolerance to a number of TNF blockers. RINVOQ 15 mg can be accepted by the European Fee for adults with average to extreme energetic rheumatoid arthritis, adults with energetic psoriatic arthritis and adults with energetic ankylosing spondylitis. RINVOQ is accepted by the European Fee for adults (15 mg and 30 mg) and adolescents (15 mg) with average to extreme atopic dermatitis. Section 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s illness, ulcerative colitis, big cell arteritis and Takayasu arteritis are ongoing.9-16
RINVOQ U.S. Makes use of and Vital Security Data1
RINVOQ is a prescription medication used to deal with adults with:
- Average to extreme rheumatoid arthritis when 1 or extra medicines known as tumor necrosis issue (TNF) blockers have been used, and didn’t work nicely or couldn’t be tolerated
- Energetic psoriatic arthritis when 1 or extra medicines known as TNF blockers have been used, and didn’t work nicely or couldn’t be tolerated.
It isn’t identified if RINVOQ is protected and efficient in youngsters below 18 years of age.
What’s a very powerful data I ought to learn about RINVOQ?
RINVOQ might trigger critical unwanted side effects, together with:
- Critical infections. RINVOQ can decrease your capacity to struggle infections. Critical infections have occurred whereas taking RINVOQ, together with tuberculosis (TB) and infections brought on by micro organism, fungi, or viruses that may unfold all through the physique. Some individuals have died from these infections. Your healthcare supplier (HCP) ought to check you for TB earlier than beginning RINVOQ and examine you intently for indicators and signs of TB throughout therapy with RINVOQ. You shouldn’t begin taking RINVOQ in case you have any type of an infection except your HCP tells you it’s okay. You might be at larger danger of growing shingles (herpes zoster).
- Elevated danger of demise in individuals 50 years and older who’ve no less than 1 coronary heart illness (cardiovascular) danger issue.
- Most cancers and immune system issues. RINVOQ might enhance your danger of sure cancers. Lymphoma and different cancers, together with pores and skin cancers, can occur. Present or previous people who smoke are at larger danger of sure cancers, together with lymphoma and lung most cancers.
- Elevated danger of main cardiovascular (CV) occasions equivalent to coronary heart assault, stroke, or demise in individuals 50 years and older who’ve no less than 1 coronary heart illness (CV) danger issue, particularly in case you are a present or previous smoker.
- Blood Clots. Blood clots within the veins of the legs or lungs and arteries can occur with RINVOQ. This can be life-threatening and trigger demise. Blood clots within the veins of the legs and lungs have occurred extra typically in people who find themselves 50 years and older and with no less than 1 coronary heart illness (CV) danger issue.
- Tears within the abdomen or intestines and modifications in sure laboratory assessments. Your HCP ought to do blood assessments earlier than you begin taking RINVOQ and when you take it. Your HCP might cease your RINVOQ therapy for a time frame if wanted due to modifications in these blood check outcomes.
What ought to I inform my HCP BEFORE beginning RINVOQ?
Inform your HCP for those who:
- Are being handled for an an infection, have an an infection that will not go away or retains coming again, or have signs of an an infection equivalent to:
̶ Fever, sweating, or chills ̶ Shortness of breath ̶ Heat, pink, or painful pores and skin or sores in your physique |
̶ Muscle aches ̶ Feeling drained ̶ Blood in phlegm ̶ Diarrhea or abdomen ache |
̶ Cough ̶ Weight reduction ̶ Burning when urinating or urinating extra typically than regular |
- Have TB or have been in shut contact with somebody with TB.
- Are a present or previous smoker.
- Have had a coronary heart assault, different coronary heart issues, or stroke.
- Have had any sort of most cancers, hepatitis B or C, shingles (herpes zoster), blood clots within the veins of your legs or lungs, diverticulitis (irritation in elements of the big gut), or ulcers in your abdomen or intestines.
- Produce other medical situations together with liver issues, low blood cell counts, diabetes, power lung illness, HIV, or a weak immune system.
- Stay, have lived, or have traveled to elements of the nation, such because the Ohio and Mississippi River valleys and the Southwest, that enhance your danger of getting sure sorts of fungal infections. If you’re uncertain for those who’ve been to those areas, ask your HCP.
- Have just lately obtained or are scheduled to obtain a vaccine. Individuals who take RINVOQ mustn’t obtain reside vaccines.
- Are pregnant or plan to turn out to be pregnant. Primarily based on animal research, RINVOQ might hurt your unborn child. Your HCP will examine whether or not or not you might be pregnant earlier than you begin RINVOQ. You need to use efficient contraception (contraception) to keep away from changing into pregnant whereas taking RINVOQ and for no less than 4 weeks after your final dose.
- Are breastfeeding or plan to breastfeed. RINVOQ might cross into your breast milk. You shouldn’t breastfeed whereas taking RINVOQ and for no less than 6 days after your final dose.
Inform your HCP about all of the medicines you are taking, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements. RINVOQ and different medicines might have an effect on one another, inflicting unwanted side effects.
Particularly inform your HCP for those who take:
- Medicines for fungal or bacterial infections
- Rifampicin or phenytoin
- Medicines that have an effect on your immune system
If you’re undecided in case you are taking any of those medicines, ask your HCP or pharmacist.
What ought to I do or inform my HCP AFTER beginning RINVOQ?
- Inform your HCP immediately in case you have any signs of an an infection. RINVOQ could make you extra more likely to get infections or make any infections you might have worse.
- Get emergency assist immediately in case you have any signs of a coronary heart assault or stroke whereas taking RINVOQ, together with:
- Discomfort within the heart of your chest that lasts for quite a lot of minutes or that goes away and comes again
- Extreme tightness, ache, stress, or heaviness in your chest, throat, neck, or jaw
- Ache or discomfort in your arms, again, neck, jaw, or abdomen
- Shortness of breath with or with out chest discomfort
- Breaking out in a chilly sweat
- Nausea or vomiting
- Feeling lightheaded
- Weak point in a single half or on one aspect of your physique
- Slurred speech
- Inform your HCP immediately in case you have any indicators or signs of blood clots throughout therapy with RINVOQ, together with:
̶ Swelling ̶ Ache or tenderness within the leg |
̶ Sudden unexplained chest ache ̶ Shortness of breath |
- Inform your HCP immediately in case you have a fever or stomach-area ache that doesn’t go away, and a change in your bowel habits.
What are the widespread unwanted side effects of RINVOQ?
These embody higher respiratory tract infections (widespread chilly, sinus infections), shingles (herpes zoster), herpes simplex, bronchitis, nausea, cough, fever, and zits. These are usually not all of the attainable unwanted side effects of RINVOQ.
How ought to I take RINVOQ?
RINVOQ is taken as soon as a day with or with out meals. Don’t break up, break, crush, or chew the pill. Take RINVOQ precisely as your HCP tells you to make use of it. RINVOQ is offered in 15 mg extended-release tablets.
That is a very powerful data to learn about RINVOQ. For extra data, speak to your HCP.
You might be inspired to report adverse unwanted side effects of prescribed drugs to the FDA. Go to www.fda.gov/medwatch or name 1-800-FDA-1088.
If you’re having issue paying to your medication, AbbVie could possibly assist. Go to AbbVie.com/myAbbVieAssist to be taught extra.
Please click on right here for the Full Prescribing Information and Medication Guide.
Globally, prescribing data varies; consult with the person nation product label for full data.
About AbbVie
AbbVie’s mission is to find and ship modern medicines that clear up critical well being points right this moment and tackle the medical challenges of tomorrow. We attempt to have a outstanding influence on individuals’s lives throughout a number of key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, ladies’s well being and gastroenterology, along with services and products throughout its Allergan Aesthetics portfolio. For extra details about AbbVie, please go to us at www.abbvie.com. Observe @abbvie on Twitter, Facebook, LinkedIn or Instagram.
Ahead-Wanting Statements
Some statements on this information launch are, or could also be thought of, forward-looking statements for functions of the Personal Securities Litigation Reform Act of 1995. The phrases “imagine,” “anticipate,” “anticipate,” “mission” and comparable expressions, amongst others, usually establish forward-looking statements. AbbVie cautions that these forward-looking statements are topic to dangers and uncertainties that will trigger precise outcomes to vary materially from these indicated within the forward-looking statements. Such dangers and uncertainties embody, however are usually not restricted to, failure to comprehend the anticipated advantages from AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly and successfully combine Allergan’s companies, competitors from different merchandise, challenges to mental property, difficulties inherent within the analysis and growth course of, opposed litigation or authorities motion, modifications to legal guidelines and rules relevant to our business and the influence of public well being outbreaks, epidemics or pandemics, equivalent to COVID-19. Further details about the financial, aggressive, governmental, technological and different elements that will have an effect on AbbVie’s operations is about forth in Merchandise 1A, “Threat Components,” of AbbVie’s 2020 Annual Report on Type 10-Ok, which has been filed with the Securities and Trade Fee, as up to date by its subsequent Quarterly Reviews on Type 10-Q. AbbVie undertakes no obligation to launch publicly any revisions to forward-looking statements because of subsequent occasions or developments, besides as required by legislation.
References:
- RINVOQ® (upadacitinib) [Package Insert]. North Chicago, Ailing.: AbbVie Inc.
- McInnes, I, et al. (2021). Trial of Upadacitinib and Adalimumab for psoriatic arthritis. New England Journal of Medication, 384(13), 1227–1239. https://doi.org/10.1056/nejmoa2022516.
- Mease, P. J., et al. (2020). Upadacitinib for psoriatic arthritis refractory to biologics: Choose-PSA 2. Annals of the Rheumatic Ailments, 80(3), 312–320. https://doi.org/10.1136/annrheumdis-2020-218870.
- RINVOQ. Arthritis Basis. Obtainable at: https://www.arthritis.org/partnership/ease-of-use-products/rinvoq#:~:text=The%20Arthritis%20Foundation’s%20Ease%20of,easy%20to%20use%20for%20everyone.
- Duarte GV, et al. Psoriatic arthritis. Greatest Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi: 10.1016/j.berh.2012.01.003.
- Ailments & Situations: Psoriatic Arthritis. 2019. American School of Rheumatology. Obtainable at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed on: September 10, 2020.
- Rodrigo Valdes-Rodriguez, M.D., Shawn G. Kwatra, M.D., Gil Yosipovitch, M.D. (2018). Itch in Psoriasis: From Fundamental Mechanisms to Sensible Therapies. Psoriasis Discussion board,Quantity: 18a situation: 3,web page(s): 110-117.
- Mease, P. J., Gladman, D. D., Papp, Ok. A., Khraishi, M. M., Thaci, D., Behrens, F., Alvarez, D. (2014) Prevalence of rheumatologist-diagnosed psoriatic arthritis in sufferers with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol, 69(5), 729-735.
- Burmester G.R., et al. Security and efficacy of upadacitinib in sufferers with rheumatoid arthritis and insufficient response to standard artificial disease-modifying anti-rheumatic medicine (SELECT-NEXT): a randomised, double-blind, placebo-controlled part 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
- A Research to Consider the Security and Efficacy of ABT-494 for Induction and Upkeep Remedy in Topics With Reasonably to Severely Energetic Ulcerative Colitis. ClinicalTrials.gov. 2020. Obtainable at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on August 17, 2020.
- A Multicenter, Randomized, Double-Blind, Placebo-Managed Research of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Topics With Reasonably to Severely Energetic Crohn’s Illness Who Have Inadequately Responded to or Are Illiberal to Immunomodulators or Anti-TNF Remedy. ClinicalTrials.gov. 2020. Obtainable at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on August 17, 2020
- A Research to Consider the Security and Efficacy of Upadacitinib in Members With Large Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2020. Obtainable at: https://clinicaltrials.gov/ct2/present/NCT03725202. Accessed: June 2021.
- A Research Evaluating Upadacitinib (ABT-494) to Placebo and to Adalimumab in Members With Psoriatic Arthritis Who Have an Insufficient Response to at Least One Non-Biologic Illness Modifying Anti-Rheumatic Drug (SELECT – PsA 1). ClinicalTrials.gov. 2020. Obtainable at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on August 17, 2020.
- A Research to Evaluate Security and Efficacy of Upadacitinib to Dupilumab in Grownup Members With Average to Extreme Atopic Dermatitis (Heads Up). ClinicalTrials.gov. 2020. Obtainable at: https://clinicaltrials.gov/ct2/present/NCT03738397. Accessed: June 2021.
- A Research to Consider Efficacy and Security of Upadacitinib in Grownup Members With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2020. Obtainable at: https://clinicaltrials.gov/ct2/present/NCT04169373. Accessed: June 2021.
- A Research to Consider the Efficacy and Security of Upadacitinib in Topics With Takayasu Arteritis (SELECT-TAK). ClinicalTrials.gov. 2020. Obtainable at https://clinicaltrials.gov/ct2/present/document/NCT04161898. Accessed: June 2021.
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