AbbVie Presents Long-Term Data Further Supporting the Efficacy and Safety Profile of RINVOQ® (upadacitinib) Across Multiple Rheumatic Diseases at the EULAR 2023 Congress

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May 24, 2023, 09:00 ET

- Five-year results from SELECT-COMPARE evaluating the efficacy and safety of RINVOQ^® (upadacitinib) and HUMIRA^® (adalimumab), both in combination with methotrexate (MTX), are reported for adult patients with moderate to severely active rheumatoid arthritis (RA) who had an inadequate response to MTX¹

- Three-year results from SELECT-PsA 1 evaluating the efficacy and safety of RINVOQ are reported in psoriatic arthritis (PsA) patients with prior inadequate response (IR) or intolerance to one or more non-biologic disease-modifying antirheumatic drugs (DMARDs)²

- One-year efficacy and safety data of RINVOQ are reported in SELECT-AXIS 2 for patients with active ankylosing spondylitis (AS) who had an inadequate response to biologic DMARD therapy³

NORTH CHICAGO, Ill., May 24, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that researchers will present new, long-term data supporting the efficacy and safety profile of RINVOQ^® (upadacitinib) from the SELECT-COMPARE, SELECT-PsA 1 and SELECT-AXIS 2 studies at the European Congress of Rheumatology, EULAR 2023, taking place from 31 May – 3 June in Milan.

"These new results from the SELECT trial programs continue to strengthen the breadth of evidence available for RINVOQ's efficacy and safety profile in several rheumatic diseases," said Mudra Kapoor, vice president, global medical affairs, immunology, AbbVie. "Our investment in long-term data is an essential part of AbbVie's ongoing commitment to ensure we are supporting patients living with immune-mediated diseases."

Long-term data supporting the efficacy and safety profile of RINVOQ that will be presented at the EULAR 2023 Congress include more than 20 clinical endpoints and safety data from approximately 2,450 patients representing more than 6,700 patient-years across rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS).^1,2,3

"The impact of rheumatic diseases, such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, can be life-long and deeply affect a patient's quality of life," said Roy Fleischmann, M.D., SELECT-COMPARE study investigator and clinical professor of medicine, University of Texas Southwestern Medical Center, co-medical director, Metroplex Clinical Research Center. "These efficacy and safety data provide additional information to help healthcare providers make important treatment choices with their patients and highlight the ability to maintain disease control with long-term treatment."

Highlights from these trials include:

Long-Term Safety and Efficacy of Upadacitinib or Adalimumab in Patients with Rheumatoid Arthritis: Five-Year Data From the SELECT-COMPARE Study
POS0849. Thurs, 1 June; 14:45-15:45 CEST
The abstract reported the safety and efficacy of RINVOQ and HUMIRA across five years in adult patients with moderate to severely active RA who had an inadequate response to methotrexate (MTX), as part of the ongoing long-term extension (LTE) of SELECT-COMPARE. Patients receiving background MTX were randomized to receive RINVOQ 15 mg once daily, HUMIRA 40 mg every other week or placebo and those who completed the 48-week double-blind period could continue to receive open label RINVOQ or HUMIRA in the LTE up to 10 years. Efficacy endpoints included Clinical Disease Activity Index (CDAI) low disease activity (LDA), CDAI remission, and disease activity scores based on 28 joints and C-reactive protein (DAS28[CRP]) ≤ 3.2 (LDA) and <2.6 (clinical remission) at five years and radiographic data at 192 weeks. Rates of treatment-emergent adverse events (TEAEs) and AEs of special interest were calculated per 100 patient-years through five years for all patients receiving RINVOQ or HUMIRA. Through five years, 1,417 patients were exposed to RINVOQ (4,497 patient-years) and 579 patients to HUMIRA (1,472 patient-years). The study results support the long-term efficacy and safety profile of RINVOQ in the studied patient population.¹

Long-Term Efficacy and Safety of Upadacitinib in Patients with Psoriatic Arthritis: Three-Year Results from the Phase 3 SELECT-PsA 1 Study
POS1541. Sat, 3 June; 10:30-11:30 CEST
The abstract reported the efficacy and safety of RINVOQ as part of the SELECT-PsA 1 study – an ongoing long-term open-label extension study in PsA patients with prior IR or intolerance to one or more non-biologic DMARD. Patients were randomized to receive RINVOQ 15 mg or 30 mg once daily, HUMIRA 40 mg every other week, or placebo. Efficacy endpoints including the American College of Rheumatology criteria (ACR20/50/70), minimal disease activity, Psoriasis Area and Severity Index (PASI75/90/100), resolution of enthesitis, resolution of dactylitis, Health Assessment Questionnaire-Disability Index (HAQ-DI), pain, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and modified total Sharp/van der Heijde score (mTSS) were assessed through week 152, and safety data through 13 June, 2022 (1,694.7 patient-years of exposure).² The study results support the efficacy and safety profile of RINVOQ in the studied patient population over three years.²

Efficacy and Safety of Upadacitinib in Patients with Active Ankylosing Spondylitis and an Inadequate Response to Biologic DMARD Therapy: One-Year Results from a Phase 3 Study
POS1122. Fri, 2 June; 9:30-10:30 CEST
This analysis evaluated efficacy over 52 weeks in patients who received RINVOQ for the whole study duration, and those who switched from placebo to RINVOQ at week 14, from the Phase 3 SELECT-AXIS 2 program. Efficacy endpoints included Assessment of SpondyloArthritis international Society 40 response (ASAS40), ASAS partial remission (PR), AS Disease Activity Score (ASDAS) with C-reactive protein [CRP], low disease activity (LDA; <2.1), ASDAS inactive disease (ID; <1.3), and changes from baseline in ASDAS and high-sensitivity CRP (hsCRP). Safety was assessed through the cut-off date of 19 May, 2022, representing 534.4 patient-years of exposure to RINVOQ.³ The study results support the efficacy and safety profile of RINVOQ in patients with active AS who had an IR or intolerance to biologic DMARDs through one year. AbbVie reported initial results at week 14 from the SELECT-AXIS 2 AS bDMARD-IR study during the EULAR 2022 Congress.

About 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.^4-16 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.⁴

Upadacitinib (RINVOQ) is in Phase 3 for giant cell arteritis, Takayasu arteritis and systemic lupus erythematosus.^11,15,18

EU Indications and Important Safety Information about RINVOQ® (upadacitinib)⁴

Indications

Rheumatoid arthritis

RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.

Psoriatic arthritis

RINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

Axial spondyloarthritis

Non-radiographic axial spondyloarthritis (nr-axSpA)

RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti- inflammatory drugs (NSAIDs).

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)

RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

Atopic dermatitis

RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.

Ulcerative colitis

RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Crohn's disease

RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Important Safety Information

Contraindications
RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.

Special warnings and precautions for use
RINVOQ should only be used if no suitable treatment alternatives are available in patients:
- 65 years of age and older;
- patients with history of atherosclerotic cardiovascular (CV) disease or other CV risk factors (such as current or past long-time smokers);
- patients with malignancy risk factors (e.g. current malignancy or history of malignancy)

Use in patients 65 years of age and older
Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients ≥65 years of age, as observed in a large randomised study of tofacitinib (another JAK inhibitor), RINVOQ should only be used in these patients if no suitable treatment alternatives are available. In patients ≥65 years of age, there is an increased risk of adverse reactions with RINVOQ 30 mg once daily. Consequently, the recommended dose for long-term use in this patient population is 15 mg once daily.

Immunosuppressive medicinal products
Use in combination with other potent immunosuppressants is not recommended.

Serious infections
Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis and sepsis have been reported with RINVOQ. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported. RINVOQ should not be initiated in patients with an active, serious infection, including localized infections. RINVOQ should be interrupted if a patient develops a serious or opportunistic infection until the infection is controlled. A higher rate of serious infections was observed with RINVOQ 30 mg compared to 15 mg. As there is a higher incidence of infections in the elderly and patients with diabetes in general, caution should be used when treating these populations. In patients ≥65 years of age, RINVOQ should only be used if no suitable treatment alternatives are available.

Tuberculosis
Patients should be screened for TB before starting RINVOQ. RINVOQ should not be given to patients with active TB. Anti-TB therapy may be appropriate for select patients in consultation with a physician with expertise in the treatment of TB. Patients should be monitored for the development of signs and symptoms of TB.

Viral reactivation
Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with RINVOQ. Consider interruption of RINVOQ if the patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should occur before and during therapy. If hepatitis B virus DNA is detected, a liver specialist should be consulted.

Vaccination
The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating RINVOQ, in agreement with current immunization guidelines.

Malignancy
Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including RINVOQ. In a large randomised active–controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma, and non-melanoma skin cancer (NMSC), was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors. A higher rate of malignancies, including NMSC, was observed with RINVOQ 30 mg compared to 15 mg. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. In patients ≥65 years of age, patients who are current or past long-time smokers, or patients with other malignancy risk factors (e.g., current malignancy or history of malignancy), RINVOQ should only be used if no suitable treatment alternatives are available.

Hematological abnormalities
Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management.

Gastrointestinal Perforations
Events of diverticulitis and gastrointestinal perforations have been reported in clinical trials and from post–marketing sources. RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation (e.g., patients with diverticular disease, a history of diverticulitis, or who are taking nonsteroidal antiinflammatory drugs (NSAIDs), corticosteroids, or opioids. Patients with active Crohn's disease are at increased risk for developing intestinal perforation. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation.

Major adverse cardiovascular events
MACE were observed in clinical studies of RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of MACE, defined as CV death, non-fatal myocardial infarction and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients ≥65 years of age, patients who are current or past long-time smokers, and patients with history of atherosclerotic CV disease or other CV risk factors, RINVOQ should only be used if no suitable treatment alternatives are available.

Lipids
RINVOQ treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.

Hepatic transaminase elevations
Treatment with RINVOQ was associated with an increased incidence of liver enzyme elevation. If alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.

Venous thromboembolism
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in clinical trials for RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a dose–dependent higher rate of VTE including DVT and PE was observed with tofacitinib compared to TNF inhibitors. In patients with CV or malignancy risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than CV or malignancy risk factors (e.g. previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder), RINVOQ should be used with caution. Patients should be re-evaluated periodically to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue RINVOQ in patients with suspected VTE.

Hypersensitivity reactions
Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving RINVOQ. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.

Adverse reactions
The most commonly reported adverse reactions in RA, PsA, and axSpA clinical trials (≥2% of patients in at least one of the indications) with RINVOQ 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, ALT increased, bronchitis, nausea, neutropenia, cough, AST increased, and hypercholesterolemia. Overall, the safety profile observed in patients with psoriatic arthritis or active axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with RA.

The most commonly reported adverse reactions in AD trials (≥2% of patients) with RINVOQ 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, blood CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza. Dose dependent increased risks of infection and herpes zoster were observed with RINVOQ. The safety profile for RINVOQ 15 mg in adolescents was similar to that in adults. The safety and efficacy of the 30 mg dose in adolescents are still being investigated.

The most commonly reported adverse reactions in the UC and CD trials (≥3% of patients) with RINVOQ 45 mg, 30 mg or 15 mg were upper respiratory tract infection, pyrexia, blood CPK increased, anemia, headache, acne, herpes zoster, neutropaenia, rash, pneumonia, hypercholesterolemia, bronchitis, aspartate transaminase increased, fatigue, folliculitis, alanine transaminase increased, herpes simplex, and influenza.

The overall safety profile observed in patients with UC was generally consistent with that observed in patients with RA.

Overall, the safety profile observed in patients with CD treated with RINVOQ was consistent with the known safety profile for RINVOQ.

The most common serious adverse reactions were serious infections.

The safety profile of upadacitinib with long–term treatment was generally similar to the safety profile during the placebo–controlled period across indications.

This is not a complete summary of all safety information.

See RINVOQ full Summary of Product Characteristics (SmPC) at www.ema.europa.eu

Globally, prescribing information varies; refer to the individual country product label for complete information.

About HUMIRA^® (adalimumab) in the European Union¹⁷

Rheumatoid arthritis

HUMIRA in combination with methotrexate, is indicated for:

the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

HUMIRA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

HUMIRA has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.

Psoriatic arthritis

HUMIRA is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.

Important EU Safety Information about HUMIRA^® (adalimumab)¹⁷HUMIRA is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients; serious allergic reactions including anaphylaxis have been reported.

The use of HUMIRA increases the risk of developing serious infections, including hepatitis B reactivation, which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with HUMIRA.

On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF- antagonists cannot be excluded. Rare cases of pancytopenia, aplastic anemia, demyelinating disease, lupus, lupus-related conditions and Stevens-Johnson syndrome have been reported in patients treated with HUMIRA.

The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

This is not a complete summary of all safety information.

See HUMIRA full summary of product characteristics (SmPC) for complete prescribing information at www.ema.europa.eu.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Rheumatology
For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Anchored by a longstanding commitment to discovering and delivering transformative therapies, we pursue cutting-edge science that improves our understanding of promising new pathways and targets, ultimately helping more people living with rheumatic diseases reach their treatment goals. For more information, visit AbbVie in rheumatology.

About AbbVie 
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. 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 and uses of future or conditional verbs, 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 expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, 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 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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