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AbbVie Showcases the Depth of its Rheumatology Portfolio with New Data Presented at the EULAR 2021 Virtual Congress of Rheumatology

·23 min read

- First presentation of three-year data from Phase 3 SELECT-COMPARE study assessing long-term efficacy and safety of RINVOQ® (upadacitinib) versus HUMIRA® (adalimumab) in patients with rheumatoid arthritis (RA)

- Presentation of 56-week efficacy and safety data from the Phase 3 SELECT-PsA 2 trial assessing RINVOQ in patients with psoriatic arthritis (PsA)

- New data from an integrated safety analysis for RINVOQ in RA

- Breadth of data presented demonstrates AbbVie's longstanding commitment to develop a portfolio of solutions that advance standards of care for people living with rheumatic diseases

NORTH CHICAGO, Ill., May 25, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it will present new data from a total of 41 abstracts covering its portfolio of immunology assets, including RINVOQ®, SKYRIZI®, HUMIRA® and its pipeline across multiple rheumatic diseases at the EULAR 2021 Virtual Congress of Rheumatology, to be held virtually June 2-5. Among the data presented will be new three-year and one-year efficacy and safety data for RINVOQ (upadacitinib) for the treatment of patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA), respectively. Additionally, AbbVie will present new integrated safety data for RINVOQ from the Phase 3 SELECT clinical trials in patients with RA up to 4.5 years of exposure.

"As a continuation of our robust scientific expertise and longstanding leadership in rheumatology, AbbVie remains committed to developing a portfolio of innovations that advance standards of care for people living with rheumatic diseases and help them reach their treatment goals," said Chiedzo Mpofu, Vice President, Global Medical Affairs, Immunology. "The data being presented at EULAR 2021 underscore this commitment."

Key data to be presented include:

  • Three-year efficacy and safety data for RINVOQ versus HUMIRA in RA patients with inadequate response to methotrexate.

  • 56-week efficacy and safety data for RINVOQ in patients with PsA and inadequate response to bDMARDs.

  • Integrated safety data for RINVOQ in patients with RA with up to 4.5 years of exposure.

  • Primary data on risankizumab (from KEEPsAKE 2 in patients with PsA and inadequate response to biologics).

  • Investigational data on ABBV-3373, a novel Anti-TNF Glucocorticoid Receptor Modulator Antibody Drug Conjugate, versus HUMIRA in patients with RA.

  • Data from a real-world population-based assessment of COVID-19 outcomes among RA patients using DMARDs.

  • Characteristics and outcomes in a real-world cohort of RA patients with COVID-19.

AbbVie oral or poster presentation data at EULAR 2021

RINVOQ Abstracts
Rheumatoid Arthritis (RA)

  • Impact of Concomitant Glucocorticoids on the Clinical Efficacy and Safety of Upadacitinib in Patients with Rheumatoid Arthritis: An Ad Hoc Analysis of Data from Three Phase 3 Studies; POS0654; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Characteristics and Six-Month Outcomes Among Real-world Rheumatoid Arthritis Patients Initiating Upadacitinib: CorEvitas' Rheumatoid Arthritis Registry; POS0435; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Patient Characteristics and Outcomes in Patients with Rheumatoid Arthritis Treated with Upadacitinib: The OM1 RA Registry; POS0436; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Long-Term Safety and Efficacy of Upadacitinib or Adalimumab in Patients With Rheumatoid Arthritis: Results at 3 Years From the SELECT-COMPARE Study; POS0087; poster presentation; Thursday, June 3; 11:56 a.m.-12:02 p.m. CEST

  • Long-term Safety and Efficacy of Upadacitinib in Patients With Rheumatoid Arthritis: 3-year Results From the SELECT-EARLY Study; POS0655; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Evaluation of Response to Pneumococcal Vaccination in Patients with Rheumatoid Arthritis Receiving Upadacitinib: Results from a Phase 2 Open-Label Extension Study; POS0508; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Routine Assessment of Patient Index Data 3 (RAPID3) in Patients With Rheumatoid Arthritis Treated With Long-term Upadacitinib Therapy; POS0670; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Integrated Safety Profile of Upadacitinib With Up to 4.5 Years of Exposure in Patients With Rheumatoid Arthritis; POS0220; poster presentation; Friday, June 4; 11:50-11:56 a.m. CEST

  • Integrated Laboratory Abnormality Profiles of Upadacitinib With up to 4.5 Years of Exposure in Patients With Rheumatoid Arthritis Treated in the SELECT Phase 3 Program; OP0128; oral presentation; Thursday, June 3; 11:15-11:22 a.m. CEST

  • Treatment Effectiveness of Upadacitinib at 3 Months in US Patients With Rheumatoid Arthritis From the United Rheumatology Normalized Integrated Community Evidence; POS0666; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Clinical Responses to Upadacitinib or Abatacept in Patients With Rheumatoid Arthritis by Type of Prior Biologic Disease-Modifying Antirheumatic Drug: Data From the Phase 3 SELECT-CHOICE Study; POS0671; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Predictors of Response: Baseline Characteristics and Early Treatment Responses Associated With Achievement of Remission and Low Disease Activity Among Upadacitinib-Treated Patients With Rheumatoid Arthritis; POS0222; poster presentation; Friday, June 4; 12:02-12:08 p.m. CEST

  • Relationship Between Changes in Lipid Levels and Improvement in Disease Activity Outcomes in Patients With Rheumatoid Arthritis Receiving Upadacitinib Treatment: Pooled Analysis of Data From Two Phase 3 Studies; POS0656; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Impact of Upadacitinib or Adalimumab as Initial Therapy on the Achievement of 48-week Treatment Goals in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate: Post Hoc Analysis of a Phase 3 Study; POS0653; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

Spondyloarthritis (SpA)

  • Upadacitinib Pharmacokinetics and Exposure-Response Relationships for Efficacy and Safety in Psoriatic Arthritis – Analyses of the Phase 3 SELECT-PsA Studies; POS1054; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Comparison of Axial and Peripheral Manifestations in Patients With Psoriatic Arthritis and Ankylosing Spondylitis Patients in Upadacitinib Clinical Trials; POS0235; poster presentation; Friday, June 4; 12:44-12:50 p.m. CEST

  • Efficacy and Safety of Upadacitinib in Patients With Psoriatic Arthritis and Axial Involvement; OP0233; oral presentation; Friday, June 4; 11:25-11:32 a.m. CEST

  • Impact of Upadacitinib on Reducing Pain in Patients With Active Psoriatic Arthritis: Results From Two Phase 3 Trials in Patients With Inadequate Response to Non-Biologic or Biologic DMARDs; POS1047; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Upadacitinib in Patients With Psoriatic Arthritis Refractory to Biologic Disease-Modifying Antirheumatic Drugs: 56-week Data From the Phase 3 SELECT-PsA 2 Study; POS0196; poster presentation; Friday, June 4; 12:14-12:20 p.m. CEST

  • Efficacy of Upadacitinib in Patients With Psoriatic Arthritis Stratified by Number of Prior Biologic Disease-Modifying Anti-Rheumatic Drugs; POS1032; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Efficacy and Safety of Upadacitinib in Patients With Active Ankylosing Spondylitis: 1-Year Results From a Randomized, Double-Blind, Placebo-Controlled Study With Open-Label Extension; OP0144; oral presentation; Thursday, June 3; 11:25-11:32 a.m. CEST

  • Upadacitinib as Monotherapy and in Combination With Non-Biologic DMARDs for the Treatment of Psoriatic Arthritis: Subgroup Analysis From Two Phase 3 Trials; POS1035; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Proteomics Analysis Comparing the Mode of Action of Upadacitinib Between Non-Biologic-DMARD-IR and Biologic-DMARD-IR PsA Patients Identifies Distinct Pathogenic Pathways in the SELECT-PsA 1 and SELECT-PsA 2 Phase 3 Studies; POS0407; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Treatment of Non-Biologic-DMARD-IR PsA Patients With Upadacitinib or Adalimumab Results in the Modulation of Distinct Functional Pathways: Proteomics Analysis of the SELECT-PsA 1 Phase 3 Study; OP0030; oral presentation; on-demand from Wednesday, June 2; 4:15-4:22 p.m. CEST

  • Targeted Serum Proteomic Analysis Following Upadacitinib Treatment in Ankylosing Spondylitis Shows Robust Suppression of Innate and Adaptive Immune Pathways With Tissue Repair Modulation; POS0920; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Efficacy of Upadacitinib in Patients With Psoriatic Arthritis Stratified by Baseline Skin Severity: A Subgroup Analysis of Two Phase III Trials; POS1030; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Influence of Baseline Demographics on Improvements in Disease Activity Measures in Patients With Ankylosing Spondylitis Receiving Upadacitinib: A Post Hoc Subgroup Analysis of SELECT-AXIS 1; POS0923; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Predictors of 1-year Treatment Response Among Upadacitinib-Treated Patients With Ankylosing Spondylitis: A Post Hoc Analysis of SELECT-AXIS 1; POS0924; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Achievement of Partial Remission and Inactive Disease in Upadacitinib-Treated Patients With Ankylosing Spondylitis; POS0905; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Effect of Upadacitinib on Reducing Pain in Patients With Active Ankylosing Spondylitis and Inadequate Response to Nonsteroidal Anti-Inflammatory Drugs; POS0907; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

HUMIRA Abstracts
Spondyloarthritis (SpA)

  • Impact of Adalimumab Versus Non-Biologic Therapy on Disease Activity and Patient-Reported Outcomes in Ankylosing Spondylitis Over 24 Months - Results of the COMPLETE-AS Canadian Observational Study; OP0143; oral presentation; June 3; 11:15 a.m. CEST

  • Clinical Effectiveness of Adalimumab Versus Non-Biologic Therapy in the Management of Extra-Articular Manifestations in Ankylosing Spondylitis Patients Over 24 Months - Results of the COMPLETE-AS Canadian Observational Study; POS0232; poster presentation; June 4; 12:26 p.m. CEST

ABBV-3373 (TNF-ADC) Abstracts
Rheumatoid Arthritis (RA)

  • Anti-TNF Glucocorticoid Receptor Modulator Antibody Drug Conjugate for the Treatment of Autoimmune Diseases; POS0365; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Efficacy and Safety of ABBV-3373, A Novel Anti-TNF Glucocorticoid Receptor Modulator Antibody Drug Conjugate, in Patients With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy: A Phase 2a Proof of Concept Study; OP0115; oral presentation; Thursday, June 3; 10:25-10:32 a.m. CEST

RISANKIZUMAB Abstracts
Spondyloarthritis (SpA)

  • Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis, Including Patients With Inadequate Response or Intolerance to Biologic Therapies: 24-week Results From The Phase 3, Randomized, Double-blind, KEEPsAKE 2 Trial; OP0228; oral presentation; Friday, June 4; 10:35-10:42 a.m. CEST

Disease State Abstracts
Rheumatoid Arthritis

  • Differences in Treatment Satisfaction, Patient Preferences, and Treatment Patterns Between European, South American, and Japanese Patients With Suboptimally Controlled Rheumatoid Arthritis: A Subgroup Analysis of the SENSE Study; POS0512; poster presentation; Wednesday, June 2; 8:00 a.m. CEST

  • Real World Population-Based Assessment of COVID-19 Outcomes Among Rheumatoid Arthritis Patients Using Biologic or Synthetic DMARDs; POS1207; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Characteristics and Outcomes in a Real-world Cohort of Rheumatoid Arthritis Patients With COVID-19; POS1163; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

Spondyloarthritis (SpA)

  • Real-world Patient Experience and Treatment Preferences in Patients With Psoriatic Arthritis; POS0062-PARE; poster presentation; Thursday, June 3; 12:20-12:26 p.m. CEST

  • Geographic Variations of Ankylosing Spondylitis (AS) Diagnosis and Treatment in the United States: A Real-World Evidence Study; POS0943; poster presentation; on-demand from Wednesday, June 2; 8:00 a.m. CEST

  • Comparison of Baseline Disease Activity and Patient-Reported Measures Between Patients With Psoriatic Arthritis and Axial Involvement and Axial Spondyloarthritis From CorEvitas' PsA/SpA Registry; OP0049; oral presentation; Wednesday, June 2; 4:45-4:52 p.m. CEST

The results of these studies will be presented as oral or poster presentations between June 2-5 at the EULAR 2021 e-congress. The full scientific program is available here: https://congress.eular.org/scientific_programme.cfm.

About RINVOQ™ (upadacitinib)

Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.1-12 In human cellular assays, RINVOQ preferentially inhibits signalling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.13 In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs; 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; and for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy. The approved dose for RINVOQ in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is 15 mg. Phase 3 trials of RINVOQ in atopic dermatitis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.5

Important EU Safety Information about RINVOQ (upadacitinib)13

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.

Use in combination with other potent immunosuppressants is not recommended.

Serious and sometimes fatal infections have been reported in patients receiving upadacitinib. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis have been reported. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/oesophageal candidiasis, and cryptococcosis have been reported with upadacitinib. Prior to initiating upadacitinib, consider the risks and benefits of treatment in patients with chronic or recurrent infection or with a history of a serious or opportunistic infection, in patients who have been exposed to TB or have resided or travelled in areas of endemic TB or endemic mycoses, and in patients with underlying conditions that may predispose them to infection. Upadacitinib therapy should be interrupted if a patient develops a serious or opportunistic infection. As there is a higher incidence of infections in patients ≥65 years of age, caution should be used when treating this population.

Patients should be screened for TB before starting upadacitinib therapy. Anti-TB therapy should be considered prior to initiation of upadacitinib in patients with previously untreated latent TB or in patients with risk factors for TB infection.

Viral reactivation, including cases of herpes zoster, were reported in clinical studies. Consider interruption of therapy if a patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should be performed before starting and during therapy with upadacitinib.

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 upadacitinib, in agreement with current immunization guidelines.

The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis (RA). Immunomodulatory medicinal products may increase the risk of malignancies, including lymphoma. The clinical data are currently limited and long-term studies are ongoing. Malignancies, including non-melanoma skin cancer (NMSC), have been reported in patients treated with upadacitinib. Consider the risks and benefits of upadacitinib treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated NMSC or when considering continuing upadacitinib therapy in patients who develop a malignancy. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

Absolute neutrophil count <1000 cells/mm1, absolute lymphocyte count <500 cells/mm1, or haemoglobin levels <8 g/dL were reported in <1% of patients in clinical trials. Treatment should not be initiated, or should be temporarily interrupted, in patients with these haematological abnormalities observed during routine patient management.

RA patients have an increased risk for cardiovascular disorders. Patients treated with upadacitinib should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care.

Upadacitinib treatment was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.

Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo. If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, upadacitinib therapy should be interrupted until this diagnosis is excluded.

Events of deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors, including upadacitinib. Upadacitinib should be used with caution in patients at high risk for DVT/PE. Risk factors that should be considered in determining the patient's risk for DVT/PE include older age, obesity, a medical history of DVT/PE, patients undergoing major surgery, and prolonged immobilisation. If clinical features of DVT/PE occur, upadacitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.

The most commonly reported adverse drug reactions (ADRs) were upper respiratory tract infections, bronchitis, nausea, blood creatine phosphokinase (CPK) increased and cough. The most common serious adverse reactions were serious infections.

Psoriatic arthritis: Overall, the safety profile observed in patients with active psoriatic arthritis treated with upadacitinib 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis. A higher incidence of acne and bronchitis was observed in patients treated with upadacitinib 15 mg (1.3% and 3.9%, respectively) compared to placebo (0.3% and 2.7%, respectively). A higher rate of serious infections (2.6 events per 100 patient–years and 1.3 events per 100 patient–years, respectively) and hepatic transaminase elevations (ALT elevations Grade 3 and higher rates 1.4% and 0.4%, respectively) was observed in patients treated with upadacitinib in combination with MTX therapy compared to patients treated with monotherapy. There was a higher rate of serious infections in patients ≥ 65 years of age, although data are limited.

Ankylosing spondylitis: Overall, the safety profile observed in patients with active ankylosing spondylitis treated with upadacitinib 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis. No new safety findings were identified.

Please see the full 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 HUMIRA® in the European Union14

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. Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy; and 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.

Important EU Safety Information about HUMIRA® (adalimumab)14

HUMIRA 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 anaemia, 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.

About SKYRIZI® (risankizumab)

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.15,16 In April 2019, SKYRIZI received U.S. Food and Drug Administration approval for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The approved dose for SKYRIZI is 150 mg (two 75 mg injections), administered by subcutaneous injection at week 0 and 4, and every 12 weeks thereafter. SKYRIZI was also approved by the European Commission in April 2019. Phase 3 trials of SKYRIZI in psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing.17-19 Use of SKYRIZI in psoriatic arthritis is not approved and its safety and efficacy have not been established by regulatory authorities.

About SKYRIZI® (risankizumab) in the European Union15

SKYRIZI (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information about SKYRIZI® (risankizumab)15

SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with SKYRIZI, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with SKYRIZI. Patients treated with SKYRIZI should not receive live vaccines during treatment and for at least 21 weeks after treatment.

The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.

This is not a complete summary of all safety information. See SKYRIZI 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 AbbVie in Rheumatology

For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment 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 order to help more people living with rheumatic diseases reach their treatment goals. For more information on AbbVie in rheumatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.html.

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 its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties, including the impact of the COVID-19 pandemic on AbbVie's operations, results and financial results, that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits of the Allergan acquisition, failure to promptly and effectively integrate Allergan's businesses, significant transaction costs and/or unknown or inestimable liabilities, potential litigation associated with the Allergan acquisition, 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 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission (SEC). AbbVie undertakes no obligation 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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  3. A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (SELECT-PsA 2). Clinicaltrials.gov. 2020. Available at: ttps://clinicaltrials.gov/ct2/show/NCT03104374. Accessed: December 2020.

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  15. SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf. Accessed on February 19, 2021.

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  17. A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03675308. Accessed on May 4, 2021.

  18. A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03105102. Accessed on May 4, 2021.

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