AbbVie Submits Applications for Upadacitinib (RINVOQ®) in Non-Radiographic Axial Spondyloarthritis to U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)

NORTH CHICAGO, In poor health., Jan. 7, 2022 /PRNewswire/ — AbbVie (NYSE: ABBV) in the present day introduced that it has submitted purposes in search of approvals for upadacitinib (RINVOQ^®, 15 mg as soon as every day) to the U.S. Meals and Drug Administration (FDA) and the European Medicines Company (EMA) for the remedy of adults with energetic non-radiographic axial spondyloarthritis (nr-axSpA) with goal indicators of irritation who’ve responded inadequately to nonsteroidal anti-inflammatory medication (NSAIDs). The purposes are supported by the Part 3 SELECT-AXIS 2 (Research 2) medical trial.

Within the SELECT-AXIS 2 trial (Research 2), evaluating the efficacy and security of upadacitinib in grownup sufferers with nr-axSpA, upadacitinib met its main and most ranked secondary endpoints.¹ Therapy with upadacitinib 15 mg as soon as every day resulted in reductions in indicators and signs of nr-axSpA, together with again ache and irritation, in addition to enhancements in bodily perform and illness exercise at week 14 versus placebo.¹

“Axial spondyloarthritis is a continual inflammatory illness affecting the backbone and might trigger sufferers, who are usually youthful adults residing energetic lives, to undergo from debilitating ache and considerably lower their high quality of life,”² mentioned Thomas Hudson, M.D., senior vp of analysis and growth, chief scientific officer, AbbVie. “AbbVie is dedicated to working with the FDA and EMA to make upadacitinib accessible as a remedy possibility for sufferers residing with this illness.”

As well as, AbbVie has requested label enhancements for upadacitinib within the European Union (EU) to incorporate grownup sufferers with energetic ankylosing spondylitis (AS) who had an insufficient response to biologic disease-modifying anti-rheumatic medication (bDMARDs), primarily based on the outcomes of the Part 3 SELECT-AXIS 2 medical trial (Research 1), in addition to two-year outcomes of the Part 2/3 SELECT-AXIS 1 medical trial.^1,3 AbbVie additionally offered these information to the FDA in help of the company’s ongoing overview of the supplemental New Drug Software (sNDA) for upadacitinib in AS.

The protection information noticed in these sufferers with AS or nr-axSpA had been usually according to the identified security profile of upadacitinib. No new security dangers had been recognized.^1,3,4,5

About axSpA
Axial spondyloarthritis is a continual inflammatory illness that impacts the backbone, inflicting again ache, restricted mobility, and structural harm.⁶ It consists of two subsets which were clinically outlined as ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).⁶ In ankylosing spondylitis, sufferers have definitive structural harm of the sacroiliac joints seen on x-rays.⁶ Non-radiographic axial spondyloarthritis is clinically outlined by the absence of definitive x-ray proof of structural harm to the sacroiliac (SI) joint by plain x-ray.⁶

About SELECT-AXIS 1 and SELECT-AXIS 2 trial packages^1,4,5,7
SELECT-AXIS 1 is a Part 2/3, multicenter, randomized, double-blind, parallel-group, placebo-controlled examine designed to guage the protection and efficacy of RINVOQ in grownup sufferers with energetic ankylosing spondylitis who’re bDMARD-naïve and had insufficient response to no less than two NSAIDs or intolerance to/contraindication for NSAIDs. Interval 2 is an open-label extension interval to guage the long-term security, tolerability and efficacy of RINVOQ in topics who accomplished Interval 1. Major outcomes from SELECT-AXIS 1 had been beforehand introduced in November 2019 with 2-year outcomes offered in November 2021. Extra data on this trial will be discovered at www.clinicaltrials.gov (NCT03178487).

SELECT-AXIS 2 was performed as a grasp examine protocol that comprises two standalone research with randomization, information assortment, evaluation and reporting performed independently. The Part 3, randomized, placebo-controlled, double-blind research are evaluating the efficacy and security of upadacitinib in contrast with placebo on discount of indicators and signs in grownup individuals with energetic axSpA together with bDMARD-IR AS (Study 1) and nr-axSpA (Study 2). Extra data on this trial will be discovered at www.clinicaltrials.gov (NCT04169373).

In all research, the first endpoint was the share of topics reaching an ASAS40 response after 14 weeks of remedy.

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. Based mostly on enzymatic and mobile assays, RINVOQ demonstrated better inhibitory efficiency for JAK-1 vs JAK-2, JAK-3, and TYK-2.⁸ The relevance of inhibition of particular JAK enzymes to therapeutic effectiveness and security is just not at present identified. RINVOQ 15 mg is accredited 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 is accredited by the European Fee for adults with reasonable to extreme energetic rheumatoid arthritis, adults with energetic psoriatic arthritis and adults with energetic ankylosing spondylitis. RINVOQ is accredited by the European Fee for adults (15 mg and 30 mg) and adolescents (15 mg) with reasonable to extreme atopic dermatitis. Part 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 Use of RINVOQ in AS is just not accredited by FDA and its security and efficacy stay beneath overview. Use of RINVOQ in nr-axSpA is just not accredited and its security and efficacy haven’t been evaluated by regulatory authorities.

RINVOQ U.S. Makes use of and Vital Security Data⁷
RINVOQ is a prescription medication used to deal with adults with:

• Average to extreme rheumatoid arthritis when 1 or extra medicines referred to as tumor necrosis issue (TNF) blockers have been used, and didn’t work properly or couldn’t be tolerated.
• Lively psoriatic arthritis when 1 or extra medicines referred to as TNF blockers have been used, and didn’t work properly or couldn’t be tolerated.

It isn’t identified if RINVOQ is secure and efficient in kids beneath 18 years of age.

What’s an important data I ought to learn about RINVOQ?
RINVOQ could trigger severe unwanted side effects, together with:

• Severe infections. RINVOQ can decrease your capability to combat infections. Severe 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 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 remedy with RINVOQ. You shouldn’t begin taking RINVOQ in case you have any form of an infection until your HCP tells you it’s okay. You could be at larger danger of growing shingles (herpes zoster).
• Elevated danger of loss of life 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 could 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 resembling coronary heart assault, stroke, or loss of life in individuals 50 years and older who’ve no less than 1 coronary heart illness (CV) danger 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 usually 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 adjustments in sure laboratory exams. Your HCP ought to do blood exams earlier than you begin taking RINVOQ and when you take it. Your HCP could cease your RINVOQ remedy for a time frame if wanted due to adjustments in these blood check outcomes.

What ought to I inform my HCP BEFORE beginning RINVOQ?

Inform your HCP should 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:

• 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, continual lung illness, HIV, or a weak immune system.
• Dwell, 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 not sure should you’ve been to those areas, ask your HCP.
• Have just lately acquired or are scheduled to obtain a vaccine. Individuals who take RINVOQ shouldn’t obtain reside vaccines.
• Are pregnant or plan to develop into pregnant. Based mostly on animal research, RINVOQ could hurt your unborn child. Your HCP will examine whether or not or not you might be pregnant earlier than you begin RINVOQ. It is best 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 could 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’re taking, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements. RINVOQ and different medicines could have an effect on one another, inflicting unwanted side effects.

Particularly inform your HCP should 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 instantly 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 have got worse.
• Get emergency assist instantly 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 various 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 facet of your physique
• Slurred speech
• Inform your HCP instantly in case you have any indicators or signs of blood clots throughout remedy with RINVOQ, together with:

• Inform your HCP instantly 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 frequent unwanted side effects of RINVOQ?
These embrace higher respiratory tract infections (frequent chilly, sinus infections), shingles (herpes zoster), herpes simplex, bronchitis, nausea, cough, fever, and zits. These should 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 cut up, break, crush, or chew the pill. Take RINVOQ precisely as your HCP tells you to make use of it. RINVOQ is out there in 15 mg extended-release tablets.

That is an important data to learn about RINVOQ. For extra data, speak to your HCP.

You’re inspired to report adverse unwanted side effects of pharmaceuticals 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.

EU Indications and Vital Security Details about RINVOQ™ (upadacitinib)

Rheumatoid arthritis
RINVOQ is indicated for the remedy of reasonable to extreme energetic rheumatoid arthritis in grownup sufferers who’ve responded inadequately to, or who’re illiberal to a number of disease-modifying anti-rheumatic medication (DMARDs). RINVOQ could also be used as monotherapy or together with methotrexate.

Psoriatic arthritis
RINVOQ is indicated for the remedy of energetic psoriatic arthritis in grownup sufferers who’ve responded inadequately to, or who’re illiberal to a number of DMARDs. RINVOQ could also be used as monotherapy or together with methotrexate.

Ankylosing spondylitis
RINVOQ is indicated for the remedy of energetic ankylosing spondylitis in grownup sufferers who’ve responded inadequately to traditional remedy.

Atopic dermatitis
RINVOQ is indicated for the remedy of reasonable to extreme atopic dermatitis in adults and adolescents 12 years and older who’re candidates for systemic remedy.

Contraindications
RINVOQ is contraindicated in sufferers hypersensitive to the energetic substance or to any of the excipients, in sufferers with energetic tuberculosis (TB) or energetic severe infections, in sufferers with extreme hepatic impairment, and through being pregnant.

Particular warnings and precautions to be used
Immunosuppressive medicinal merchandise 
Use together with different potent immunosuppressants is just not really useful.

Severe infections
Severe and generally deadly infections have been reported in sufferers receiving upadacitinib. Essentially the most frequent severe infections reported included pneumonia and cellulitis. Circumstances of bacterial meningitis have been reported. Amongst opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported with upadacitinib. As there’s a larger incidence of infections in sufferers ≥65 years of age, warning must be used when treating this inhabitants.

Viral reactivation
Viral reactivation, together with circumstances of herpes zoster, was reported in medical research. The danger of herpes zoster seems to be larger in Japanese sufferers handled with upadacitinib.

Vaccinations
The usage of reside, attenuated vaccines throughout or instantly previous to remedy is just not really useful. It’s endorsed that sufferers be introduced updated with all immunizations, together with prophylactic zoster vaccinations, previous to initiating upadacitinib, in settlement with present immunization pointers.

Malignancy
The danger of malignancies, together with lymphoma is elevated in sufferers with rheumatoid arthritis (RA). Malignancies, together with nonmelanoma pores and skin most cancers (NMSC), have been reported in sufferers handled with upadacitinib. Take into account the dangers and advantages of upadacitinib remedy previous to initiating remedy in sufferers with a identified malignancy aside from a efficiently handled NMSC or when contemplating persevering with upadacitinib remedy in sufferers who develop a malignancy.

Hematological abnormalities
Therapy shouldn’t be initiated, or must be quickly interrupted, in sufferers with hematological abnormalities noticed throughout routine affected person administration.

Diverticulitis
Upadacitinib must be used with warning in sufferers with diverticular illness and particularly in sufferers chronically handled with concomitant medicines related to an elevated danger of diverticulitis.

Cardiovascular danger
RA sufferers have an elevated danger for cardiovascular problems. Sufferers handled with upadacitinib ought to have danger elements (e.g., hypertension, hyperlipidemia) managed as a part of typical commonplace of care.

Lipids
Upadacitinib remedy was related to dose-dependent will increase in lipid parameters, together with complete ldl cholesterol, low-density lipoprotein ldl cholesterol, and high-density lipoprotein ldl cholesterol.

Hepatic transaminase elevations
Therapy with upadacitinib was related to an elevated incidence of liver enzyme elevation in comparison with placebo

Venous thromboembolisms
Occasions of deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in sufferers receiving JAK inhibitors, together with upadacitinib. Upadacitinib must be used with warning in sufferers at excessive danger for DVT/PE.

Antagonistic reactions
Essentially the most generally reported antagonistic reactions in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis medical trials (≥2% of sufferers in no less than one of many indications) with upadacitinib 15 mg had been higher respiratory tract infections, blood creatine phosphokinase (CPK) elevated, alanine transaminase (ALT) elevated, bronchitis, nausea, cough, aspartate transaminase (AST) elevated, and hypercholesterolemia.

Essentially the most generally reported antagonistic reactions in atopic dermatitis trials (≥2% of sufferers) with upadacitinib 15 mg or 30 mg had been higher respiratory tract an infection, zits, herpes simplex, headache, CPK elevated, cough, folliculitis, stomach ache, nausea, neutropenia, pyrexia, and influenza.

The most typical severe antagonistic reactions had been severe infections.

The protection profile of upadacitinib with long run remedy was usually much like the protection profile through the placebo-controlled interval throughout indications.

Total, the protection profile noticed in sufferers with psoriatic arthritis or energetic ankylosing spondylitis handled with upadacitinib 15 mg was according to the protection profile noticed in sufferers with RA.

In atopic dermatitis, dose-dependent elevated dangers of an infection and herpes zoster had been noticed with upadacitinib. Based mostly on restricted information, there was a better fee of general antagonistic reactions with the upadacitinib 30 mg dose in comparison with the 15 mg dose in sufferers aged 65 years and older. The protection profile for upadacitinib 15 mg in adolescents was much like that in adults. The protection and efficacy of the 30 mg dose in adolescents are nonetheless being investigated. Dose-dependent adjustments in ALT elevated and/or AST elevated (≥ 3 x ULN), lipid parameters, CPK values (> 5 x ULN), and neutropenia (ANC < 1 x 10⁹ cells/L) related to upadacitinib remedy had been much like what was noticed within the rheumatologic illness medical research.

This isn’t an entire abstract of all security data.

See RINVOQ full abstract of product traits (SmPC) at www.ema.europa.eu. Globally, prescribing data varies; seek advice from the person nation product label for full data

About AbbVie in Rheumatology
For greater than 20 years, AbbVie has been devoted to bettering look after individuals residing with rheumatic illnesses. Our longstanding dedication to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in an effort to assist extra individuals residing with rheumatic illnesses attain their remedy objectives. For extra data on AbbVie in rheumatology, go to https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.html.

About AbbVie
AbbVie’s mission is to find and ship modern medicines that remedy severe well being points in the present day and tackle the medical challenges of tomorrow. We attempt to have a exceptional influence on individuals’s lives throughout a number of key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, girls’s well being and gastroenterology, along with services throughout its Allergan Aesthetics portfolio. For extra details about AbbVie, please go to us at www.abbvie.com. Observe @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Ahead-Trying 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 “consider,” “count on,” “anticipate,” “challenge” and comparable expressions, amongst others, usually determine forward-looking statements. AbbVie cautions that these forward-looking statements are topic to dangers and uncertainties, together with the influence of the COVID-19 pandemic on AbbVie’s operations, outcomes and monetary outcomes, which will trigger precise outcomes to vary materially from these indicated within the forward-looking statements. Such dangers and uncertainties embrace, however should not restricted to, failure to appreciate the anticipated advantages of the Allergan acquisition, failure to promptly and successfully combine Allergan’s companies, vital transaction prices and/or unknown or inestimable liabilities, potential litigation related to the Allergan acquisition, challenges to mental property, competitors from different merchandise, difficulties inherent within the analysis and growth course of, antagonistic litigation or authorities motion, and adjustments to legal guidelines and laws relevant to our business. Further details about the financial, aggressive, governmental, technological and different elements which will have an effect on AbbVie’s operations is about forth in Merchandise 1A, “Danger Components,” of AbbVie’s 2020 Annual Report on Type 10-Okay, which has been filed with the Securities and Alternate Fee (SEC). AbbVie undertakes no obligation to launch publicly any revisions to forward-looking statements because of subsequent occasions or developments, besides as required by regulation.

References:
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² Axial Spondyloarthritis. Arthritis Basis. Obtainable at: https://www.arthritis.org/diseases/ankylosing-spondylitis. Accessed December 2021. 
³ AbbVie. Knowledge on File: ABVRRTI73012
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¹⁰ A Research to Consider the Security and Efficacy of ABT-494 for Induction and Upkeep Remedy in Topics With Reasonably to Severely Lively Ulcerative Colitis. ClinicalTrials.gov. 2020. Obtainable at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed: November 2021.
¹¹ 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 Lively 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: November 2021.
¹² 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/show/NCT03725202. Accessed: November 2021.
¹³ A Research Evaluating Upadacitinib (ABT-494) to Placebo in Members With Lively Psoriatic Arthritis Who Have a Historical past of Insufficient Response to at Least One Biologic Illness Modifying Anti-Rheumatic Drug (SELECT-PsA 2). Clinicaltrials.gov. 2020. Obtainable at: https://clinicaltrials.gov/ct2/show/NCT03104374. Accessed: November 2021.
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