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

Published: 2021-05-25 12:00:00 ET

- 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 AbstractsSpondyloarthritis (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) AbstractsRheumatoid 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 AbstractsSpondyloarthritis (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 AbstractsRheumatoid 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.

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