RINVOQ® (upadacitinib) Approved by U.S. FDA as an Oral Treatment for Adults with Active Ankylosing Spondylitis

• Throughout the 2 pivotal trials, RINVOQ delivered speedy and significant illness management with almost half of ankylosing spondylitis (AS) sufferers reaching ASAS40 (51% and 44.5% with RINVOQ versus 26% and 18.2% with placebo) at week 14 in comparison with placebo¹
• RINVOQ demonstrated vital enchancment in indicators and signs of AS at week 14^1-4
• FDA approval in AS marks the fifth indication for RINVOQ in persistent immune-mediated ailments¹

NORTH CHICAGO, Ailing., April 29, 2022 /PRNewswire/ — AbbVie (NYSE: ABBV) as we speak introduced that the U.S. Meals and Drug Administration (FDA) has authorised RINVOQ^® (upadacitinib; 15 mg, as soon as day by day) for the remedy of adults with lively ankylosing spondylitis (AS) who’ve had an insufficient response or intolerance to a number of tumor necrosis issue (TNF) blockers.¹

“Ankylosing spondylitis is a debilitating illness that usually impacts youthful adults and, over time, can lead to lasting structural harm that may take an emotional toll on a affected person’s life,” stated Thomas Hudson, M.D., senior vice chairman, analysis and improvement, chief scientific officer, AbbVie. “This newest approval demonstrates one other vital step ahead in our mission to advance the requirements of care in rheumatic ailments.”

The FDA approval in AS is supported by efficacy and security information from the Part 3 SELECT-AXIS 2 scientific trial (Examine 1) evaluating RINVOQ in sufferers who had an insufficient response or intolerance to 1 or two biologic disease-modifying anti-rheumatic medication (bDMARDs) and the Part 2/3 SELECT-AXIS 1 scientific trial evaluating RINVOQ in sufferers who had been naïve to bDMARDs and had an insufficient response or intolerance to not less than two nonsteroidal anti-inflammatory medication (NSAIDs).^1-3 

“Many sufferers with ankylosing spondylitis don’t obtain illness management with present biologic therapies and extra therapies are wanted to assist relieve the indicators and signs of this illness,” stated Atul Deodhar, M.D., professor of drugs and medical director of the Rheumatology Clinics for the Division of Arthritis and Rheumatic Illnesses at Oregon Well being & Science College, and investigator of the SELECT-AXIS 1 trial. “With as we speak’s FDA approval, sufferers who don’t reply to a TNF inhibitor have an extra oral remedy possibility, in partnership with their rheumatologist, to assist take management of this illness.”

In each SELECT-AXIS 1 and SELECT-AXIS 2 scientific trials, a considerably higher proportion of sufferers receiving RINVOQ 15 mg achieved an ASAS40* response, the first endpoint, (51% and 44.5%, respectively) in comparison with these receiving placebo (26% and 18.2%, respectively) at week 14. Medical responses had been noticed as early as week 4 in SELECT-AXIS 2 for ASAS40.^1,3

“At the moment, there are restricted remedy choices for folks dwelling with ankylosing spondylitis, notably when painful signs persist regardless of being on a TNF blocker remedy,” stated Cassie Shafer, chief government officer, Spondylitis Affiliation of America (SAA). “The approval of a brand new medication is welcome information to our group of sufferers, providing the potential to assist extra folks discover significant reduction from the signs of AS and to assist attain their remedy objectives.”

AS is a persistent inflammatory musculoskeletal illness primarily affecting the backbone and characterised by debilitating signs of inflammatory again ache, stiffness and restricted mobility. An estimated one out of each 200 adults within the U.S., or roughly 1.1 million folks, is affected by AS.⁵

Further research outcomes embrace the next:

Enchancment in AS Indicators & Signs at Week 14^1-3

Therapy with RINVOQ 15 mg resulted in enhancements within the indicators and signs of AS, together with whole again ache, in addition to enhancements in bodily operate (Tub Ankylosing Spondylitis Useful Index (BASFI)) and illness exercise (Affected person World Evaluation of Illness Exercise) versus placebo at week 14. 

In SELECT-AXIS 2, sufferers receiving RINVOQ 15 mg at week 14 skilled:

• A considerably higher imply lower from baseline in Complete Again Ache (-3.1 change from baseline) in comparison with these receiving placebo (-1.5).⁶
• A considerably higher enchancment in bodily operate (-2.3 change from baseline) as assessed by imply change from baseline in BASFI in comparison with sufferers on placebo (-1.09).⁶

*ASAS40 is a composite index that measures illness exercise.² To attain an ASAS40 response, a affected person’s illness exercise should have improved by not less than 40%, in addition to improved by two items in not less than three of 4 illness areas assessed, and the remaining space should not have gotten worse, together with again ache, affected person world evaluation of illness exercise, bodily practical and morning stiffness.²

Security¹

• Total, the protection profile noticed in sufferers with lively AS handled with RINVOQ 15 mg was per the protection profile noticed in sufferers with rheumatoid arthritis and psoriatic arthritis.¹
• RINVOQ might trigger severe unintended effects, together with:
• Critical infections. RINVOQ can decrease your means to struggle infections. Critical infections, some deadly, occurred whereas taking RINVOQ, together with tuberculosis (TB) and infections attributable to micro organism, fungi, or viruses.
• Elevated threat of loss of life in folks 50 years and older with not less than 1 coronary heart illness threat issue.
• Most cancers and immune system issues. RINVOQ might enhance your threat of sure cancers, together with lymphoma and pores and skin most cancers. Present or previous people who smoke are at increased threat for lymphoma and lung most cancers.
• Elevated threat of main cardiovascular occasions resembling coronary heart assault, stroke, or loss of life in folks 50 years and older with not less than 1 coronary heart illness threat issue, particularly in present or previous people who smoke.
• Blood clots, some deadly, within the veins of the legs or lungs and arteries. This occurred extra typically in folks 50 years and older with not less than 1 coronary heart illness threat issue.
• Critical allergic reactions. Don’t take if allergic to RINVOQ or any of its substances.
• Tears within the abdomen or intestines and modifications in sure laboratory take a look at outcomes.

For extra details about RINVOQ in AS, go to RINVOQ.com.

Affected person Entry & Help
AbbVie is dedicated to serving to folks entry RINVOQ and different medicines, together with providing a affected person assist program and a co-pay card that will scale back out-of-pocket prices to $5 per 30 days for eligible, commercially insured sufferers. For these with restricted or no medical insurance, AbbVie provides myAbbVie Help, a affected person help program that gives RINVOQ at no cost to those that qualify. For extra particulars, please go to AbbVie.com/myAbbVieAssist.

About SELECT-AXIS 1 and SELECT-AXIS 2 trial packages^2,3
SELECT-AXIS 1 is a Part 2/3, multicenter, randomized, double-blind, parallel-group, placebo-controlled research designed to judge the protection and efficacy of RINVOQ in grownup sufferers with lively ankylosing spondylitis (AS) who’re bDMARD-naïve and had insufficient response to not less than two NSAIDs or intolerance to/contraindication for NSAIDs. Interval 2 is an open-label extension interval to judge the long-term security, tolerability and efficacy of RINVOQ in topics who accomplished Interval 1. Extra info on this trial might be discovered at www.clinicaltrials.gov (NCT03178487).

SELECT-AXIS 2 was carried out as a grasp research protocol that accommodates two standalone research with randomization, information assortment, evaluation and reporting carried out independently. The Part 3, randomized, placebo-controlled, double-blind research are evaluating the efficacy and security of RINVOQ in contrast with placebo on discount of indicators and signs in grownup members with lively axial spondyloarthritis (axSpA), together with bDMARD-IR AS (Examine 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Examine 2). Extra info on this trial might be discovered at https://www.clinicaltrials.gov/ (NCT04169373).

In each scientific trials, the first endpoint was the share of topics reaching an ASAS40 response after 14 weeks of remedy with RINVOQ versus placebo.

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 ailments. Based mostly on enzymatic and mobile assays, RINVOQ demonstrated higher 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 shouldn’t be at the moment recognized.

Within the U.S., RINVOQ 15 mg is authorised for adults with reasonably to severely lively rheumatoid arthritis who’ve had an insufficient response or intolerance to a number of TNF blockers; adults with lively psoriatic arthritis who’ve had an insufficient response or intolerance to a number of TNF blockers; and adults with lively ankylosing spondylitis (AS) who’ve had an insufficient response or intolerance to a number of tumor necrosis issue (TNF) blockers.¹ RINVOQ 45 mg is authorised to be used in grownup sufferers with reasonably to severely lively ulcerative colitis who’ve had an insufficient response or intolerance to a number of TNF blockers as an induction remedy as soon as day by day for 8 weeks. The really helpful dose of RINVOQ for upkeep remedy is 15 mg as soon as day by day. A dosage of 30 mg as soon as day by day could also be thought of for sufferers with refractory, extreme or intensive illness. Discontinue RINVOQ if an ample response shouldn’t be achieved with the 30 mg dose. Use the bottom efficient dosage wanted to keep up response. RINVOQ 15 mg as soon as day by day may also be initiated in adults and youngsters 12 years of age and older weighing not less than 40 kg with refractory, reasonable to extreme atopic dermatitis whose illness shouldn’t be adequately managed with different system drug merchandise, together with biologics or when use of these therapies is inadvisable. In these kids and adults lower than 65 years of age who don’t obtain an ample response, the dose could also be elevated to 30 mg as soon as day by day.

Part 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s illness, ulcerative colitis, large cell arteritis and Takayasu arteritis are ongoing.^7-13

RINVOQ^® (upadacitinib) U.S. Use and Necessary Security Data¹

RINVOQ is a prescription medication used to deal with:

• Adults with reasonable to extreme rheumatoid arthritis when 1 or extra tumor necrosis issue (TNF) blockers have been used, and didn’t work properly or couldn’t be tolerated.
• Adults with lively psoriatic arthritis when 1 or extra tumor necrosis issue (TNF) blockers have been used, and didn’t work properly or couldn’t be tolerated.
• Adults with reasonable to extreme ulcerative colitis when 1 or extra medicines known as TNF blockers have been used, and didn’t work properly or couldn’t be tolerated.
• Adults with lively ankylosing spondylitis when 1 or extra medicines known as TNF blockers have been used, and didn’t work properly or couldn’t be tolerated.

It isn’t recognized if RINVOQ is protected and efficient in kids with juvenile idiopathic arthritis, psoriatic arthritis, ulcerative colitis, or ankylosing spondylitis.

• Adults and youngsters 12 years of age and older with reasonable to extreme eczema (atopic dermatitis) that didn’t reply to earlier remedy and whose eczema shouldn’t be properly managed with different capsules or injections, together with biologic medicines, or when the usage of different capsules or injections shouldn’t be really helpful.

RINVOQ is protected and efficient in kids 12 years of age and older weighing not less than 88 kilos (40 kg) with atopic dermatitis.

It isn’t recognized if RINVOQ is protected and efficient in kids beneath 12 years of age with atopic dermatitis.

What’s an important info I ought to find out about RINVOQ?

RINVOQ might trigger severe unintended effects, together with:

• Critical infections. RINVOQ can decrease your means to struggle infections. Critical infections have occurred whereas taking RINVOQ, together with tuberculosis (TB) and infections attributable to micro organism, fungi, or viruses that may unfold all through the physique. Some folks have died from these infections. Your healthcare supplier (HCP) ought to take a look at you for TB earlier than beginning RINVOQ and examine you carefully for indicators and signs of TB throughout remedy with RINVOQ. You shouldn’t begin taking RINVOQ in case you have any type of an infection until your HCP tells you it’s okay. When you get a severe an infection, your HCP might cease your remedy till your an infection is managed. You could be at increased threat of growing shingles (herpes zoster).
• Elevated threat of loss of life in folks 50 years and older who’ve not less than 1 coronary heart illness (cardiovascular) threat issue.
• Most cancers and immune system issues. RINVOQ might enhance your threat of sure cancers. Lymphoma and different cancers, together with pores and skin cancers, can occur. Present or previous people who smoke are at increased threat of sure cancers, together with lymphoma and lung most cancers.  Observe your HCP’s recommendation about having your pores and skin checked for pores and skin most cancers throughout remedy with RINVOQ. Restrict the period of time you spend in daylight. Put on protecting clothes if you end up within the solar and use sunscreen.
• Elevated threat of main cardiovascular (CV) occasions, resembling coronary heart assault, stroke, or loss of life, in folks 50 years and older who’ve not less than 1 coronary heart illness (CV) threat issue, particularly if you’re 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 loss of life. 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 not less than 1 coronary heart illness (CV) threat issue.
• Allergic reactions. Signs resembling rash (hives), hassle respiratory, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that will imply you’re having an allergic response have been seen in folks taking RINVOQ. A few of these reactions had been severe. If any of those signs happen throughout remedy with RINVOQ, cease taking RINVOQ and get emergency medical assist immediately.
• Tears within the abdomen or intestines and modifications in sure laboratory exams. Your HCP ought to do blood exams earlier than you begin taking RINVOQ and when you take it. Your HCP might cease your RINVOQ remedy for a time frame if wanted due to modifications in these blood take a look at outcomes.

Don’t take RINVOQ if:

• You’re allergic to upadacitinib or any of the substances in RINVOQ.

What ought to I inform my HCP BEFORE beginning RINVOQ?

Inform your HCP in case you:

• 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 resembling:
• 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 kind 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 massive gut), or ulcers in your abdomen or intestines.
• Produce other medical circumstances together with liver issues, low blood cell counts, diabetes, persistent lung illness, HIV, or a weak immune system.
• Reside, have lived, or have traveled to elements of the nation, such because the Ohio and Mississippi River valleys and the Southwest, that enhance your threat of getting sure sorts of fungal infections. If you’re uncertain in case you’ve been to these kind of areas, ask your HCP.
• Have just lately obtained or are scheduled to obtain a vaccine. Individuals who take RINVOQ shouldn’t obtain stay vaccines.
• Are pregnant or plan to turn out to be pregnant. Based mostly on animal research, RINVOQ might hurt your unborn child. Your HCP will examine whether or not or not you’re pregnant earlier than you begin RINVOQ. You need to use efficient contraception (contraception) to keep away from changing into pregnant throughout remedy with RINVOQ and for 4 weeks after your final dose.
• Are breastfeeding or plan to breastfeed. RINVOQ might cross into your breast milk. Don’t breastfeed throughout remedy with RINVOQ and for six 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 unintended effects.

Particularly inform your HCP in case you take:

• Medicines for fungal or bacterial infections
• Rifampicin or phenytoin
• Medicines that have an effect on your immune system

If you’re unsure if you’re 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 will 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 middle of your chest that lasts for quite a lot of minutes or that goes away and comes again
• Extreme tightness, ache, strain, 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 remedy with RINVOQ, together with:
• Swelling
• Ache or tenderness in one or each legs
• Sudden unexplained chest or higher again ache
• Shortness of breath or problem respiratory
• 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 opposite attainable unintended effects of RINVOQ?
Widespread unintended effects embrace higher respiratory tract infections (widespread chilly, sinus infections), shingles (herpes zoster), herpes simplex virus infections (together with chilly sores), bronchitis, nausea, cough, fever, zits, headache, elevated blood ranges of creatine phosphokinase, allergic reactions, irritation of hair follicles, stomach-area (belly) ache, elevated weight, flu, tiredness, decrease variety of sure varieties of white blood cells (neutropenia, lymphopenia), muscle ache, flu-like sickness, rash, elevated blood levels of cholesterol, and elevated liver enzyme ranges.  

A separation or tear to the liner of the again a part of the attention (retinal detachment) has occurred in folks with atopic dermatitis handled with RINVOQ. Name your HCP immediately in case you have any sudden modifications in your imaginative and prescient throughout remedy with RINVOQ.

These usually are not all of the attainable unintended 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, crush, or chew the pill. Take RINVOQ precisely as your HCP tells you to make use of it. RINVOQ is obtainable in 15 mg, 30 mg, and 45 mg extended-release tablets.

That is an important info to find out about RINVOQ. For extra info, speak to your HCP. 

You’re inspired to report destructive unintended effects of prescribed drugs to the FDA. Go to http://www.fda.gov/medwatch or name 1-800-FDA-1088.

If you’re having problem paying to your medication, AbbVie could possibly assist. Go to AbbVie.com/myAbbVieAssist to study extra. 

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

Globally, prescribing info varies; confer with the person nation product label for full info.

About AbbVie in Rheumatology
For greater than 20 years, AbbVie has been devoted to bettering take care of folks dwelling with rheumatic ailments. Anchored by a longstanding dedication to discovering and delivering transformative therapies, we pursue cutting-edge science that improves our understanding of promising new pathways and targets, in the end serving to extra folks dwelling with rheumatic ailments attain their remedy objectives. For extra info, go to AbbVie in rheumatology.

About AbbVie
AbbVie’s mission is to find and ship revolutionary medicines that resolve severe well being points as we speak and deal with the medical challenges of tomorrow. We attempt to have a exceptional impression on folks’s lives throughout a number of key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, and ladies’s well being, along with services throughout our 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 related expressions, amongst others, typically 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 embrace, however usually are not restricted to, failure to understand 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 improvement course of, hostile litigation or authorities motion, modifications to legal guidelines and laws relevant to our trade and the impression of public well being outbreaks, epidemics or pandemics, resembling COVID-19. Further details about the financial, aggressive, governmental, technological and different components that will have an effect on AbbVie’s operations is about forth in Merchandise 1A, “Danger Components,” of AbbVie’s 2021 Annual Report on Kind 10-Ok, which has been filed with the Securities and Change Fee, as up to date by its subsequent Quarterly Studies on Kind 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.

*Dr. Atul Deodhar, M.D., is a researcher/guide for AbbVie.

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SOURCE AbbVie