Life Science News

SELECT-PsA 1 & 2 highlight the efficacy and safety data of RINVOQ at two years in psoriatic arthritis (PsA) patients with an inadequate response or intolerance to ≥1 non-biologic DMARD, and in PsA patients with prior inadequate response or intolerance to ≥1 bDMARD, respectively - KEEPsAKE 1 & 2 trials showcase the efficacy and safety data of SKYRIZI ® (risankizumab) in patients with active PsA

NORTH CHICAGO, Ill. , May 24, 2022 /PRNewswire/ -- ABBVie (NYSE: ABBV) today announced accepted abstracts and presentations, including three oral presentations, three poster tours and 25 posters, at the European Alliance of Associations for Rheumatology (EULAR) 2022 Congress. The range of data accepted for presentation showcases ABBVie's commitment to discovering and delivering diverse and innovative solutions for the management of rheumatic diseases. The hybrid congress will take place from 1-4 June in Copenhagen , as well as virtually.

"For more than two decades, AbbVie has helped to raise the bar in the care of patients with rheumatic diseases to help patients control their disease and inhibit disease progression," said Chiedzo Mpofu, MBChB, Ph.D., vice president, Global Medical Affairs, Immunology, AbbVie. "We continue that legacy of our scientific ambition as evidenced by the research we are presenting at this year's EULAR Congress, which showcases AbbVie's relentless pursuit of innovation and our aspiration to help eliminate the burden of rheumatic disease for patients."

Key data to be presented include:

  • SELECT-AXIS 2 trial results that were submitted in regulatory filings for upadacitinib (RINVOQ ® ) in the U.S. and Europe . The trial evaluated the efficacy and safety of upadacitinib in patients with non-radiographic axial spondyloarthritis (nr-axSpA) and in patients with active ankylosing spondylitis (AS) with an inadequate response to bDMARDs (bDMARD-IR)
  • Results from the impact of treatment with RINVOQ vs HUMIRA ® (adalimumab) on RAPID3 in patients in SELECT-PsA 1
  • Two-year data from the SELECT-PsA 1 and SELECT-PsA 2 studies of RINVOQ in patients with psoriatic arthritis (PsA)
  • Results of the one-year data evaluating the efficacy and safety of SKYRIZI ® (risankizumab) in patients with active PsA in KEEPsAKE 1 and KEEPsAKE 2
  • Efficacy and safety results from several rheumatoid arthritis studies of RINVOQ in different patient populations, including the Phase 2 long-term BALANCE-EXTEND and Phase 3 SELECT-COMPARE studies in patients with an inadequate response to methotrexate (MTX-IR), and the SELECT-BEYOND and SELECT-CHOICE studies in bDMARD-IR patients

AbbVie abstracts at EULAR include:

Abstract Title

Session Details (All Times CEST) *

Upadacitinib / Rheumatoid Arthritis

Consistency in Time to Response with Upadacitinib as Monotherapy or Combination Therapy and Across Patient Populations with Rheumatoid Arthritis

POS0677; poster session; 1-4 June

Clinical Outcomes Associated with Glucocorticoid Discontinuation Among Patients with Rheumatoid Arthritis Receiving Upadacitinib or Adalimumab

POS0540; poster session; 1-4 June

Predictors of Remission in Rheumatoid Arthritis Patients Treated with Upadacitinib or Adalimumab in the SELECT-COMPARE Phase 3 Study: Clinical Status at Week 12, but not Standard Laboratory Measures, Provides the Best Current Predictor of Remission at Week 26

POS0541; poster session; 1-4 June

Long-Term Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis: Final Results from the BALANCE-EXTEND Open-Label Extension Study

POS0685; poster session; 1-4 June

Rheumatoid Arthritis Patients Who Switched Treatment from Adalimumab to Upadacitinib Demonstrate a Robust Reduction of Inflammation-Related Biomarkers: Proteomics Analysis from the SELECT-COMPARE Phase 3 Study

POS0692; poster session; 1-4 June

Effectiveness of Upadacitinib in the Treatment of Rheumatoid Arthritis: Analysis of 6-month Real-World Data from the United Rheumatology Normalized Integrated Community Evidence (UR-NICE TM ) Database

POS0686; poster session; 1-4 June

Efficacy and Safety of Upadacitinib in TNFi-IR Patients with Rheumatoid Arthritis from Three Phase 3 Clinical Trials

POS0683; poster session; 1-4 June

Impact of Upadacitinib versus Abatacept on Individual Disease Outcomes in Patients with Rheumatoid Arthritis and Inadequate Responses to Biologic DMARDs

POS0693; poster session; 1-4 June

Sustainability of Response Between Upadacitinib and Adalimumab in Patients with Rheumatoid Arthritis: Results Through Three Years from the SELECT-COMPARE Trial

POS0643; poster session; 1-4 June

Sustainability of Response to Upadacitinib Among Patients with Active Rheumatoid Arthritis Refractory to Biological Disease-Modifying Anti-Rheumatic Drugs

AB0333; abstract supplement

Impact of Serologic Status on Clinical Responses to Upadacitinib or Abatacept in Patients with Rheumatoid Arthritis and Prior Inadequate Response to Biologic DMARDs: Sub-Group Analysis from the Phase 3 SELECT-CHOICE Study

AB0352; abstract supplement

Efficacy and Safety of Upadacitinib in a Chinese Subgroup of Patients with Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic Disease-Modifying Antirheumatic Drugs

AB0392; abstract supplement

Is Upadacitinib Capable of Improving Patient-Reported Outcomes of Rheumatoid Arthritis in a Real-World Setting? Results from the Post-Marketing Observational UPwArds Study

POS0684; poster session; 1-4 June

Upadacitinib / Spondyloarthritis

Association Between Clinically Meaningful Improvements in Patient-Reported Outcomes and Stringent Measures of Disease Activity in Patients with Psoriatic Arthritis Treated with Upadacitinib Versus Placebo or Adalimumab: Results from a Phase 3 Trial

AB0889; abstract supplement

Evaluating Numeric Rating Scale Versions of the 3 and 4 Visual Analog Scale (3/4-VAS) Composite Measures in Patients with Active Psoriatic Arthritis from the SELECT-PsA Program

AB0904; abstract supplement

Predictors for Achievement of Low Disease Activity at Week 56 in Patients with Psoriatic Arthritis Who Received Upadacitinib 15 mg Once Daily: Pooled Analysis of Two Phase 3 Studies

POS1026; poster session; 1-4 June

Comparison of Composite Indices for Disease Activity in Patients with Psoriatic Arthritis Treated with Upadacitinib: A Post-Hoc Analysis from SELECT-PsA 1

POS1025; poster session; 1-4 June

Efficacy and Safety of Upadacitinib in Patients with Active Ankylosing Spondylitis Refractory to Biologic Therapy: A Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial

POS0306; poster tour; 4 June; 11:37-11:45am

Efficacy and Safety of Upadacitinib in Patients with Active Non-Radiographic Axial Spondyloarthritis: A Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial

OP0016; oral presentation; 1 June; 4:35 – 4:45pm

Long-Term Efficacy and Safety of Upadacitinib in Patients with Psoriatic Arthritis: Two-Year Results from the Phase 3 SELECT-PsA 1 Study

POS0081; poster tour; 2 June; 1:14 – 1:22pm

Long-Term Efficacy and Safety of Upadacitinib in Patients with Psoriatic Arthritis Refractory to Biologic Therapies: Two-Year Results from the Phase 3 SELECT-PsA 2 Study

POS1041; poster session; 1-4 June

Differentiation Between IL-6 and IL-17 Pathway Inhibition in Relationship with Clinical Outcomes in Non-Biological DMARD-IR and Biological DMARD-IR Psoriatic Arthritis Patients Treated with Upadacitinib in SELECT-PsA 1 and SELECT-PsA 2 Studies

OP0024; oral presentation; 1 June; 4:35 – 4:45pm

Efficacy of Upadacitinib on Psoriatic Arthritis with Axial Involvement Defined by Investigator Assessment and PRO-Based Criteria: Results from Two Phase 3 Studies

POS0934; poster session; 1-4 June

Upadacitinib Versus Adalimumab on Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Psoriatic Arthritis

POS1050; poster session; 1-4 June

Risankizumab / Psoriatic Arthritis

Long-Term Safety of Risankizumab in Patients with Psoriatic Disease: Findings from Integrated Analyses of 17 Clinical Trials in Psoriasis and Four in Psoriatic Arthritis

POS1023; poster session; 1-4 June

Impact of Risankizumab on Enthesitis and Associated Pain: Pooled Results from the Phase 3, Randomized, Double-Blind KEEPsAKE 1 and 2 Trials

POS1057; poster session; 1-4 June

Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Active Psoriatic Arthritis (PsA) After Inadequate Response or Intolerance to DMARDs: Pooled Results from the Phase 3, Randomized, Double-Blind KEEPsAKE 1 and 2 Trials

AB0905; abstract supplement

Effects of Treatment with Risankizumab on Minimal Disease Activity (MDA) and Disease Activity in Psoriatic Arthritis (DAPSA): An Analysis of the KEEPsAKE 1 and 2 Trials

POS1029; poster session; 1-4 June

Effects of Treatment with Risankizumab on Reducing Pain and Inflammation in Patients with Psoriatic Arthritis: An Analysis of KEEPsAKE 1 and 2 Trials

AB0901; abstract supplement

Efficacy and Safety of Risankizumab (RZB) for Active Psoriatic Arthritis (PsA): 52-Week Results from KEEPsAKE 2

POS1036; poster session; 1-4 June

Efficacy and Safety of Risankizumab (RZB) for Active Psoriatic Arthritis (PsA): 52-Week Results from KEEPsAKE 1

POS1024; poster session; 1-4 June

Impact of Risankizumab on Improving Health-Related Quality of Life, Work Productivity, and Reducing Fatigue Among Patients with Active Psoriatic Arthritis: A Pooled Analysis of Two Phase 3 Clinical Trials

POS1042; poster session; 1-4 June

Risankizumab for Active Psoriatic Arthritis: Integrated Subgroup Analysis from Two Double-Blind, Placebo-Controlled, Phase 3 Studies (KEEPsAKE 1 and KEEPsAKE 2)

POS1032; poster session; 1-4 June

Impact of Risankizumab on Improving Symptoms and Health-Related Quality of Life and Reducing Fatigue and Pain Among Psoriatic Arthritis Patients with Moderate-to-Severe Skin Involvement: Evidence from Two Phase 3 Trials

AB0897; abstract supplement

Disease State Abstracts: Spondyloarthritis

Radiographic Progression from Non-Radiographic to Radiographic Axial Spondyloarthritis: Results from a 5-Year Multi-Country Prospective Observational Study

OP0149; oral presentation; 2 June; 10:45 – 10:55am

Disease State Abstracts: Psoriatic Arthritis

Clinical and Economic Burden of Patients with Psoriatic Arthritis with and without Axial Involvement

POS1064; poster session; 1-4 June

Residual Burden and Disease Activity of Canadian PsA Patients Treated with Advanced Therapies: Preliminary Results from a Multiple Registry Analysis (UNISON-PsA)

AB0895; abstract supplement

Disease State Abstracts: Rheumatoid Arthritis

A Canadian Retrospective Chart Review Evaluating Concomitant Methotrexate De-Escalation Patterns in RA Patients Treated with Biologic or Targeted Synthetic DMARDs

POS0288; poster tour; 4 June; 10:33 – 10:41am

Persisting Pain in Rheumatoid Arthritis: Do We Need to Reconsider Our Idea of Pain Alleviation Despite Anti-Inflammatory Treatment?

POS0598; poster session; 1-4 June

Improving Treat-to-Target Implementation in Rheumatoid Arthritis: A Systematic Literature Review of Barriers, Facilitators, and Interventions

POS0607; poster session; 1-4 June

*Poster sessions will take place onsite 1-4 June and will be available on the EULAR online platform until 31 July, 2022 .

SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading the development and commercialization of SKYRIZI globally.

The full EULAR scientific program is available here: https://congress.eular.org/scientific_programme.cfm .

About RINVOQ ® (upadacitinib) 1
Discovered and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. 2 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. 1

In the U.S., RINVOQ is approved for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers, adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers, as well as adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers. 3 RINVOQ is approved for use in adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable. RINVOQ is approved for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.

In the EU, RINVOQ is approved for the treatment of adults 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; for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy; and for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis. 1

Phase 3 trials of RINVOQ in atopic dermatitis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing. 4-11 Use of RINVOQ in nr-axSpA is not approved and remains under review by regulatory authorities.

EU Indications and Important Safety Information about RINVOQ ® (upadacitinib) 1

Indications

Rheumatoid arthritis

RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis 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 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.

Ankylosing spondylitis

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 in adults and adolescents 12 years and older who are candidates for systemic therapy.

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

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 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/esophageal candidiasis, and cryptococcosis have been reported with upadacitinib. As there is a higher incidence of infections in patients ≥65 years of age, caution should be used when treating this population.

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 upadacitinib.

Vaccinations

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.

Malignancy

The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis (RA). Malignancies, including nonmelanoma 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.

Hematological abnormalities

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

Diverticulitis

Upadacitinib should be used with caution in patients with diverticular disease and especially in patients chronically treated with concomitant medications associated with an increased risk of diverticulitis.

Cardiovascular risk

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

Lipids

Upadacitinib 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 upadacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo.

Venous thromboembolisms

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.

Adverse reactions

The most commonly reported adverse reactions in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis clinical trials (≥2% of patients in at least one of the indications) with upadacitinib 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, alanine transaminase (ALT) increased, bronchitis, nausea, cough, aspartate transaminase (AST) increased, and hypercholesterolemia.

The most commonly reported adverse reactions in atopic dermatitis trials (≥2% of patients) with upadacitinib 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza. 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.

Overall, the safety profile observed in patients with psoriatic arthritis or active ankylosing spondylitis treated with upadacitinib 15 mg was consistent with the safety profile observed in patients with RA. In atopic dermatitis, dose-dependent increased risks of infection and herpes zoster were observed with upadacitinib. Based on limited data, there was a higher rate of overall adverse reactions with the upadacitinib 30 mg dose compared to the 15 mg dose in patients aged 65 years and older.

The safety profile for upadacitinib 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. Dose-dependent changes in ALT increased and/or AST increased (≥ 3 x ULN), lipid parameters, CPK values (> 5 x ULN), and neutropenia (ANC 9 cells/L) associated with upadacitinib treatment were similar to what was observed in the rheumatologic disease clinical studies.

This is not a complete summary of all safety information.

See RINVOQ full summary of product characteristics (SmPC) at www.ema.europa.eu/en .

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

About SKYRIZI ® (risankizumab) 12

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. 12 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis. 12 SKYRIZI is approved in the U.S. to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, as well as to treat active psoriatic arthritis in adults. In the EU, SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy; SKYRIZI, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). 12 The approved dose for SKYRIZI is 150 mg (one 150 mg pre-filled pen or pre-filled syringe) administered by subcutaneous injection at week 0 and 4, and every 12 weeks thereafter. Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing. 2,12-15

EU Indications and Important Safety Information about SKYRIZI ® (risankizumab) 12

SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SKYRIZI, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).

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 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. 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 HUMIRA ® (adalimumab) in the European Union 16

HUMIRA, in combination with methotrexate, is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to DMARDs, 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 DMARD therapy has been inadequate.

Important EU Safety Information about HUMIRA ® (adalimumab) 16

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 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. 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 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 from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. 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 2021 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 to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References

  1. RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; May 2022 . Available at: https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf . Accessed on May 10, 2022 .
  2. Pipeline – Our Science | AbbVie. AbbVie. 2019. Available at: https://www.abbvie.com/our-science/pipeline.html . Accessed on April 1, 2022.
  3. RINVOQ (upadacitinib) [Package Insert]. North Chicago, Ill. : AbbVie Inc.
  4. A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone (SELECT-NEXT). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02675426 . Accessed on April 1, 2022.
  5. Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema) (Measure Up 1). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03569293 . Accessed on April 1, 2022.
  6. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400 . Accessed on April 1, 2022.
  7. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373 . Accessed on April 1, 2022.
  8. A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03345836 . Accessed on April 1, 2022.
  9. A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635 . Accessed on April 1, 2022.
  10. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202 . Accessed on April 1, 2022.
  11. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04161898 . Accessed on April 1, 2022.
  12. 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 08 April, 2022.
  13. A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov 2021. Available at https://www.clinicaltrials.gov/ct2/show/NCT03105128 . Accessed on April 8, 2022.
  14. A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(ies) (KEEPsAKE2). ClinicalTrials.gov. 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT03671148 . Accessed on April 8, 2022.
  15. A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2022. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03398148 . Accessed on April 8, 2022.
  16. HUMIRA [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co KG; September 2021. Available at: https://www.ema.europa.eu/en/documents/product-information/humira-epar-product-information_en.pdf .

Cision View original content: https://www.prnewswire.com/news-releases/abbvie-showcases-its-leadership-in-rheumatology-research-with-new-data-across-multiple-inflammatory-joint-diseases-at-the-eular-2022-congress-301553100.html

SOURCE AbbVie

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ABBV
Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to announce it has entered into a global exclusive licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE: ABBV), pursuant to which Allergan Aesthetics will develop and commercialize topical skin care treatments based on active ingredients derived from certain of Sirona's patents for TFC-1067 and related family of compounds.

"We are very pleased to have finalized terms with a global leader in medical aesthetics and the innovator behind SkinMedica™, a leader in the science of skin rejuvenation," said Dr. Howard Verrico, CEO of Sirona Biochem. "Our most recent clinical trial of TFC-1067 was a collaborative effort with Allergan Aesthetics to demonstrate the clinical potential in topical skin care treatments. This further validates our platform technology as viable for additional commercial products which we are actively pursuing. We would like to thank Dr. Linda Pullan of Pullan Consulting who assisted with our current success."

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Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending the granting of a marketing authorization for ZINBRYTA™
(daclizumab) intended for the treatment of relapsing forms of multiple
sclerosis (RMS), Biogen
(NASDAQ: BIIB) and AbbVie (NYSE:
ABBV) announced today. ZINBRYTA is a once-monthly, self-administered,
subcutaneous investigational treatment for RMS. ZINBRYTA is also
currently under regulatory review in the United States, Switzerland,
Canada and Australia.
For people with relapsing forms of MS (RMS) and active disease,
ZINBRYTA has the potential to offer robust efficacy, a manageable safety
profile through patient monitoring, and once-monthly subcutaneous
dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and
chief medical officer at Biogen. “ZINBRYTA may offer another option for
people with multiple sclerosis (MS) with its targeted mechanism of
action (MOA) which did not cause broad and prolonged immune cell
depletion.”
The CHMP positive opinion is now referred to the European Commission
(EC), which grants marketing authorizations for centrally authorized
medicines in the European Union. A decision from the EC is expected
within the coming months.
Together with Biogen, AbbVie is committed to meeting the needs of
patients with MS, and the positive opinion issued by the CHMP is a
critical step that moves us closer to bringing ZINBRYTA to patients in
Europe,” said Michael Severino, M.D., executive vice president, research
and development and chief scientific officer, AbbVie.
According to the CHMP opinion, the benefits of ZINBRYTA are its ability
to reduce the annualized relapse rate (ARR), as well as the risk of
24-week confirmed disability progression. The opinion is based on
results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA
150 mg, administered subcutaneously every four weeks improved results on
key measures of MS disease activity in patients with RMS compared to
AVONEX 30 mcg intramuscular injection administered weekly and placebo,
respectively.
In the DECIDE study, the overall incidence of adverse events was similar
in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA
compared to AVONEX, there was an increased incidence of serious
infections (4% versus 2%), serious cutaneous reactions (2% versus <1%),
elevations of liver transaminases greater than five times the upper
limit of normal (6% versus 3%), gastrointestinal disorders (31% versus
24%), and depression (8% versus 6%).
About ZINBRYTA™ (daclizumab)
ZINBRYTA (daclizumab) is an investigational compound being developed for
the treatment of relapsing forms of MS. ZINBRYTA is a new form of a
humanized monoclonal antibody that selectively binds to the
high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is
expressed at high levels on T-cells that become activated in people with
MS. ZINBRYTA modulates IL-2 signaling without general immune cell
depletion.
Biogen and AbbVie are jointly developing ZINBRYTA.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological, autoimmune and rare diseases. Founded in 1978,
Biogen is one of the world’s oldest independent biotechnology companies
and patients worldwide benefit from its leading multiple sclerosis and
innovative hemophilia therapies. For more information, please visit www.biogen.com.
Follow us on Twitter.
Biogen Safe Harbor
This press release contains forward-looking statements, including
statements about the anticipated timing of the EC’s decision on the
marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA,
if approved. These statements may be identified by words such as
“believe,” “expect,” “may,” “potential,” “will” and similar expressions,
and are based on our current beliefs and expectations. You should not
place undue reliance on these statements. Drug development and
commercialization involve a high degree of risk. Factors which could
cause actual results to differ materially from our current expectations
include the risk that the EC may fail to approve or may delay approval
of ZINBRYTA or may not follow the recommendation of the CHMP,
uncertainty of success in commercialization of ZINBRYTA For more
detailed information on the risks and uncertainties associated with our
drug development and commercialization activities and risks relating to
our collaborations with third parties, please review the Risk Factors
section of our most recent annual or quarterly report filed with the
Securities and Exchange Commission. Any forward-looking statements speak
only as of the date of this press release and we assume no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in
2013 following separation from Abbott Laboratories. The company’s
mission is to use its expertise, dedicated people and unique approach to
innovation to develop and market advanced therapies that address some of
the world’s most complex and serious diseases. Together with its
wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000
people worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com.
Follow @abbvie on
Twitter or view careers on our Facebook or LinkedIn
page.
Forward-Looking Statements
Some statements in this news release may be 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 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, 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,” in AbbVie’s 2014 Annual Report on
Form 10-K, which has been filed with the Securities and Exchange
Commission. 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.

Enbrel Biosimilar Marks Victory for Merck and Samsung

The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel.
According to Fierce Biotech:

Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung.
Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars.
The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion.
Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.

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The Gummy Project Announces Official Launch of E-Commerce Sales Channel

The Gummy Project Announces Official Launch of E-Commerce Sales Channel

  • The Gummy Project'S Watermelon Sharks and Peachy Bees are now available for pre-sale purchase at www.shopgummies.com
  • Shipping and fulfilment of online orders will commence on July 11, 2022

The Gummy Project (CSE: GUMY) (FSE: 0OS2) (OTCQB: POTVF) ("GUMY" or the "Company") is pleased to announce the official launch of its new e-commerce site at www.shopgummies.com.

"The launch of our e-commerce site is a major milestone, making our product available across Canada for the first time," said Anthony Gindin, Chief Marketing Officer at GUMY. "This really marks our official launch into the Canadian market with e-commerce being a major component in our overall sales channel strategy. The site provides a vehicle for continued growth as well as a platform to share our story and fulfil our mandate to support endangered keystone species."

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Cardiol Therapeutics Reports Results of 2022 Annual General Meeting

Cardiol Therapeutics Reports Results of 2022 Annual General Meeting

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of cannabidiol as an anti-inflammatory and anti-fibrotic therapy for the treatment of cardiovascular diseases ("CVD"), announces the results from its Annual General Meeting of Shareholders (the "AGM") held virtually via live audio webcast, on June 28, 2022. Shareholders voted in favour of all management resolutions proposed in the Company's Information Circular.

Resolutions proposed and approved at the AGM were:

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The Gummy Project Announces Another Milestone with Entry into Canadian Retail Market

The Gummy Project Announces Another Milestone with Entry into Canadian Retail Market

  • The Gummy Project'S Watermelon Sharks and Peachy Bees to be sold at Vancouver based Stong's Markets
  • Stong's are Vancouver owned full-service grocery stores that have operated in Vancouver since 1931

The Gummy Project (CSE: GUMY) (FSE: 0OS2) (OTCQB: POTVF) ("GUMY" or the "Company") is pleased to announce that as of June 29, 2022 it has partnered with Stong's to launch its Watermelon Sharks and Peachy Bees into the Canadian retail market.

"This partnership represents another great step in our ongoing sales strategy and we're extremely proud to partner with Stong's, an iconic grocery store in Vancouver," said Charlie Lamb, President and CEO of GUMY. "Following our recent partnership announcements with Flair Airlines and Bard on the Beach, the upcoming launch of our ecommerce site on June 30 2022, and our distribution partnership with Dean's Dairy and Specialty Foods, consumers will soon be able to purchase our products at locations across Canada."

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Health Canada Approves OPDIVO® as Monotherapy for the Adjuvant treatment of Adults with Urothelial Carcinoma at High Risk of Recurrence after Undergoing Radical Resection of UC

First adjuvant Immunotherapy for patients at high risk of disease recurrence

Today, Bristol Myers Squibb Canada (BMS) announced Health Canada has issued a Notice of Compliance with Conditions (NOCc) for OPDIVO ® , as a monotherapy for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. i OPDIVO ® is the first immuno-oncology treatment to bring benefit in the adjuvant setting of UC and represents a potential new standard of care for patients at high risk of disease recurrence. ii Unlike traditional cancer therapies that target the tumour directly, immuno-oncology activates the body's own immune system to help recognize and attack cancer cells. iii

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Kite's CAR T-cell Therapy Yescarta® Granted European Marketing Authorization for the Treatment of Relapsed or Refractory Follicular Lymphoma

Pivotal ZUMA-5 Study Demonstrates Overall Response Rate of 91% and a Complete Response rate of 77% in Patients Who Received Yescarta After Three or More Lines of Therapy –

Kite's Third Approved Cell Therapy Indication in Europe

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Gilead Resubmits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting HIV-1 Capsid Inhibitor

NDA Resubmission Addresses Issues Related to Vial Compatibility –

If Approved, Lenacapavir Would be the First and the Only HIV-1 Treatment Option Administered Twice-Yearly

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