AbbVie to Showcase New Data at the United European Gastroenterology Week Virtual 2021

AbbVie today announced new data on the investigational use of risankizumab (SKYRIZI ® ) in Crohn's disease, upadacitinib (RINVOQ ® ) in ulcerative colitis and HUMIRA ® (adalimumab) in inflammatory bowel disease (IBD) will be presented as live presentations and e-Posters at the United European Gastroenterology (UEG) Week Virtual 2021, to be held October 3-5 . AbbVie is presenting a total of 13 abstracts, across a broad range of studies in IBD, including two late-breaking maintenance studies evaluating the efficacy and safety of risankizumab in Crohn's disease and upadacitinib in ulcerative colitis at 52 weeks.

"Our long-term commitment to IBD has yielded favorable results, and the data we are presenting at UEG Week Virtual 2021 shows the potential of AbbVie's pipeline to help transform the way IBD is treated," said Chiedzo Mpofu, vice president, global medical affairs, immunology. "We continue to work to evolve the standards of care and improve symptom control and quality of life for people living with IBD."

Four presentations will feature data from the pivotal Phase 3 U-ACHIEVE and U-ACCOMPLISH studies evaluating the efficacy, safety and rapidity of symptom control with upadacitinib in patients with moderate to severe ulcerative colitis. These studies evaluated improvements in abdominal pain, bowel urgency and fatigue. During UEG Week Virtual 2021, results of the pivotal Phase 3 maintenance study, in which the primary endpoint of clinical remission (per Adapted Mayo Score) was met, will be disclosed as a late-breaking presentation . ³ Additionally, all secondary endpoints, including endoscopic improvement, histologic-endoscopic mucosal improvement and corticosteroid-free clinical remission at week 52 were met and will be presented. ³ Clinical remission (per Adapted Mayo Score) is defined as Mayo score ≤2, with a stool frequency subscore (SFS) ≤1 and not greater than baseline, rectal bleeding subscore (RBS) of 0 and Mayo endoscopic subscore ≤1. ³ New data highlighting the impact of upadacitinib on health-related quality of life will also be presented. Top-line induction results were previously announced in December 2020 and February 2021 . Top-line maintenance results were announced in June 2021 .

Other presentations will focus on risankizumab as an induction therapy in patients with moderate to severe Crohn's disease. Analysis from two Phase 3 studies emphasizing early symptom relief will be shared, along with a pooled analysis evaluating clinical response after an additional 12 weeks of risankizumab treatment in subjects who failed to achieve clinical response initially. Additionally, results from the Phase 3 FORTIFY study will be presented as a late-breaker. This presentation will highlight the efficacy outcomes of continued treatment with risankizumab (360 mg), which met the co-primary endpoints of endoscopic response and clinical remission at week 52. ⁴ Clinical remission was defined by Crohn's Disease Activity Index (CDAI) in the U.S. analysis plan and by stool frequency and abdominal pain (SF/AP) in the OUS analysis plan. ⁴ Top-line induction results were issued in January 2021 .

"We are excited by the strong research AbbVie is producing in IBD, addressing the high unmet needs," said Remo Panaccione , M.D., professor of medicine and director of the IBD unit, University of Calgary . "More treatment options are needed to help control symptoms and improve quality of life for patients suffering from moderate to severe ulcerative colitis and Crohn's disease."

AbbVie abstracts in the UEG Week Virtual 2021 program include:

Upadacitinib   Abstracts
Ulcerative Colitis (UC)

• Patients with ulcerative colitis report improvements in abdominal pain, bowel urgency, and fatigue with 8-week upadacitinib treatment in two Phase 3 Trials: U-ACHIEVE and U-ACCOMPLISH; OP021; live abstract-based session; Oct 3 ; 12:00-12:12 CEST
• Efficacy of upadacitinib induction therapy in patients with moderately to severely active ulcerative colitis by biologic inadequate responder status: results from two randomized Phase 3 studies; OP017; live abstract-based session; Oct 3 ; 10:42-10:54 CEST
• Rapidity of symptom control with upadacitinib induction therapy in patients with moderately to severely active ulcerative colitis: results from two randomized Phase 3 studies; OP043; live abstract-based session; Oct 3 ; 13:54-14:06 CEST
• Upadacitinib treatment improves health-related quality of life among patients with moderately to severely active ulcerative colitis: results from the Phase 3 induction studies U-ACHIEVE and U-ACCOMPLISH; P0497; e-Poster presentation; Oct 3 ; 9:00 CEST
• Efficacy and safety of upadacitinib maintenance therapy in patients with moderately to severely active ulcerative colitis: results from a randomized Phase 3 Study; LB11; live abstract-based session; Oct 4 ; 10:30-10:42 CEST

Risankizumab Abstracts
Crohn's Disease (CD)

• An additional 12 weeks of risankizumab therapy induces clinical response in patients with moderate to severe Crohn's disease who failed to achieve clinical response after an initial induction period: 24-week pooled analysis of two Phase 3 studies; OP125; live abstract-based session; Oct 4 ; 15:48-16:00 CEST
• Risankizumab as induction therapy in patients with moderately to severely active Crohn's disease who failed 1 vs >1 prior biologic treatment: results from the MOTIVATE study; OP194; live abstract-based session; Oct 5 ; 14:06-14:18 CEST
• Risankizumab induction therapy provides early symptom improvements in abdominal pain and stool frequency in patients with moderate to severe Crohn's disease: results from two Phase 3 induction studies; P0476; e-Poster presentation; Oct 3 ; 9:00 CEST
• Efficacy and safety of risankizumab as maintenance therapy in patients with Crohn's disease: 52 week results from the Phase 3 FORTIFY study; LB13; live abstract-based session; Oct 4 ; 10:54-11:06 CEST

Adalimumab Abstracts
Inflammatory Bowel Disease (IBD)

• Mechanisms of non-response to adalimumab in inflammatory bowel disease: peripheral proteomic and transcriptomic profiling from the SERENE-CD and SERENE-UC studies; OP195; live abstract-based session; Oct 5 ; 14:18-14:30 CEST
• A higher induction dosing regimen of adalimumab does not enhance modulation of downstream blood molecular markers in patients with moderately to severely active Crohn's disease or ulcerative colitis: results from the SERENE-CD and SERENE-UC studies; P0453; e-Poster presentation; Oct 3 ; 9:00 CEST
• The impact of non-medical switching from originator to biosimilar infliximab vs continuing on originator in inflammatory bowel disease: results of Project NORTH; P0420; e-Poster presentation; Oct 3 ; 9:00 CEST

Disease State Abstracts

• Prognostic value of intestinal ultrasound parameters for long-term outcomes in IBD patients – one year interim results of the TRUST BEYOND study; OP123; live abstract-based session; Oct 4 ; 15:24-15:36 CEST

The full scientific program for the UEG Week Virtual 2021 is available here .

AbbVie will also host a virtual media education event on October 6 from 9:00 AM – 10:00 AM CDT ( 4:00 PM – 5:00 PM CEST ), featuring a panel of experts discussing the burden of living with IBD, unmet needs in the management of IBD and AbbVie's commitment to the IBD community, following UEG Week Virtual 2021. Interested media can reach out to hannah.martinez@abbvie.com or jenina.nunez@abbvie.com to register.

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

About Ulcerative Colitis

Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon. ^5,6 The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence. ^5,7 The disease course of ulcerative colitis varies between patients and can range from quiescent disease to chronic refractory disease, which in some cases can lead to surgery or complications, including cancer or death. ^6,8 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease. ⁹

About Crohn's Disease

Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal (or digestive) tract, causing persistent diarrhea, abdominal pain and rectal bleeding. ^6,10-11 It is a progressive disease, meaning it gets worse over time. ^6,11 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically, but also emotionally and economically. ⁹

About Upadacitinib (RINVOQ ^® )

Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. ^12-19 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. ¹² RINVOQ is approved by the European Commission for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis. RINVOQ 15 mg is approved by the European Commission for adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis and adults with active ankylosing spondylitis. RINVOQ 15 mg is also approved by the U.S. Food and Drug Administration (FDA) for adults with moderately to severely active rheumatoid arthritis. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing. ^13-19 The use of upadacitinib in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About Risankizumab (SKYRIZI ^® )

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. ^20,21 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including Crohn's disease. ²⁰ 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, administered by prefilled pen or prefilled syringe at week 0 and 4, and every 12 weeks thereafter. SKYRIZI was also approved in psoriasis by the European Commission in April 2019 . Phase 3 trials of SKYRIZI in psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing. ^22-24 The use of risankizumab in Crohn's disease is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About HUMIRA ^® in the European Union ²⁵

HUMIRA is approved for the treatment of moderate to severe Crohn's disease.

EU Indications and Important Safety Information About RINVOQ ^® (upadacitinib) ¹²

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.

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.

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

About SKYRIZI ^® (risankizumab) in the European Union ²¹

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) ²¹

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.

Important EU Safety Information about HUMIRA ^® (adalimumab) ²⁵

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.

Please see the full SmPC for complete prescribing information at   www.EMA.europa.eu .  

This is not a complete summary of all safety information.

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

About AbbVie in Gastroenterology

With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.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 , LinkedIn or Instagram .

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, 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 2020 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.

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