AbbVie Showcases Its Leadership in Research in Inflammatory Bowel Diseases with New Analyses to be Presented at the 17th Congress of European Crohn's and Colitis Organization

ABBVie (NYSE: ABBV) will present further analyses on HUMIRA ® (adalimumab) and the investigational uses of risankizumab (SKYRIZI ® ) and upadacitinib (RINVOQ ® ) at the 17th Congress of European Crohn's and Colitis Organisation (ECCO), to be held February 16-19. ABBVie will present 26 abstracts, including 8 oral presentations, 8 digital oral presentations and 10 posters from a broad range of studies across its inflammatory bowel disease (IBD) portfolio.

"We are excited for the opportunity to present further analyses from our IBD portfolio, including studies of our pipeline assets and HUMIRA. Our presence at ECCO underscores our relentless commitment to research that we hope will help transform patient care and change the lives of those living with inflammatory bowel disease," said Chiedzo Mpofu, MBChB, PhD, vice president, global medical affairs, immunology, AbbVie.

The presentations at ECCO 2022 include new post-hoc analyses from the pivotal Phase 3 risankizumab program (ADVANCE, MOTIVATE and FORTIFY) in Crohn's disease, evaluating efficacy by baseline Crohn's disease location, durable improvements in endoscopic outcomes and treatment outcomes based on baseline disease duration. Top-line results from the induction and maintenance studies were previously announced in January 2021 and June 2021 , respectively.

Additionally, AbbVie will present results from a post-hoc analysis of Phase 3 upadacitinib pivotal trials (U-ACHIEVE induction and U-ACCOMPLISH) evaluating ulcerative colitis symptoms as early as day 1 in upadacitinib-treated patients with ulcerative colitis. Top-line induction results were previously announced in December 2020 and February 2021 . Top-line results from the maintenance study were announced in June 2021 .

"By understanding the needs of IBD patients, we've embraced the challenge that is finding additional solutions for today and tomorrow," said Remo Panaccione , MD, professor of medicine and director of the IBD unit, University of Calgary . "AbbVie's research at ECCO represents their dedication to seek solutions that will help serve many of these patients who continue to be in need of relief from the burden of living with IBD, particularly those who haven't responded well enough to conventional therapy."

AbbVie abstracts in the ECCO 2022 program include:

Risankizumab Abstracts
Crohn's Disease (CD)

• Achievement of steroid-free remission in patients with moderately to severely active Crohn's disease during treatment with risankizumab; DOP82; digital oral presentation; Feb. 18 ; 17:25-17:31 CET
• Normalization of biomarkers and improvement in clinical outcomes in patients with Crohn's disease treated with risankizumab in the Phase 3 ADVANCE, MOTIVATE, and FORTIFY studies; DOP83; digital oral presentation; Feb. 18 ; 17:32-17:38 CET
• Risankizumab maintenance therapy results in sustained improvements in endoscopic outcomes in patients with moderate to severe Crohn's disease: Post-hoc analysis from the Phase 3 study FORTIFY; DOP84; digital oral presentation; Feb. 18 ; 17:39-17:45 CET
• Efficacy of risankizumab rescue therapy in patients with moderately to severely active Crohn's disease and inadequate response to risankizumab maintenance therapy; DOP85; digital oral presentation; Feb. 18 ; 17:46-17:52 CET
• Patients with moderate to severe Crohn's disease with and without prior biologic failure demonstrate improved endoscopic outcomes with risankizumab: Results from Phase 3 induction and maintenance trials; OP25; oral presentation; Feb. 18 ; 16:34-16:44 CET
• Shorter disease duration is associated with better outcomes in patients with moderately to severely active Crohn's disease treated with risankizumab: Results from the Phase 3 ADVANCE, MOTIVATE, and FORTIFY studies; OP39; oral presentation; Feb. 19 ; 11:40-11:50 CET
• Efficacy of risankizumab induction and maintenance therapy by baseline Crohn's disease location: Post hoc analysis of the Phase 3 ADVANCE, MOTIVATE, and FORTIFY studies; OP40; oral presentation; Feb. 19 ; 11:50-12:00 CET
• Early improvement of endoscopic outcomes with risankizumab is associated with reduced hospitalization and surgery rates in patients with Crohn's disease; P380; poster session; Feb. 18 ; 12:30-13:30 CET
• Patients with moderate to severe Crohn's disease with and without prior biologic failure demonstrated improved clinical outcomes with risankizumab: Results from Phase 3 induction and maintenance trials; P544; poster session; Feb. 18 ; 12:30-13:30 CET
• Population pharmacokinetic and exposure-response analyses for efficacy and safety of risankizumab in subjects with active Crohn's disease; P574; poster session; Feb. 18 ; 12:30-13:30 CET

Upadacitinib   Abstracts
Ulcerative Colitis (UC)

• Upadacitinib therapy reduces ulcerative colitis symptoms as early as day 1; DOP38; digital oral presentation; Feb. 17 ; 17:37-17:43 CET
• Effect of baseline disease characteristics on clinical outcomes in moderate-to-severe ulcerative colitis treated with upadacitinib: Results from a Phase 3 trials program; DOP39; digital oral presentation; Feb. 17 ; 17:44-17:50 CET
• Impact of corticosteroid usage on efficacy and safety outcomes in patients receiving upadacitinib for ulcerative colitis; DOP40; digital oral presentation; Feb. 17 ; 17:51-17:57 CET
• Efficacy and safety of extended induction treatment with upadacitinib 45 mg once daily followed by maintenance upadacitinib 15 or 30 mg once daily in patients with moderately to severely active ulcerative colitis; DOP41; digital oral presentation; Feb. 17 ; 17:58-18:04 CET
• The effects of maintenance therapy with upadacitinib on abdominal pain, bowel urgency, and fatigue in patients with moderately to severely active ulcerative colitis: Phase 3 U-ACHIEVE maintenance results; OP08; oral presentation; Feb. 17 ; 16:50-17:00 CET
• Upadacitinib modulates inflammatory pathways in gut tissue in patients with ulcerative colitis: Transcriptomic profiling from the Phase 2b study, U-ACHIEVE; OP30; oral presentation; Feb. 18 ; 16:00-16:10 CET
• Effect of upadacitinib (UPA) treatment on extraintestinal manifestations (EIMs) in patients with moderate-to-severe ulcerative colitis (UC): Results from the UPA Phase 3 program; OP33; oral presentation; Feb. 18 ; 08:50-09:00 CET
• Efficacy and safety of advanced induction and maintenance therapies in patients with moderately to severely active ulcerative colitis: An indirect treatment comparison using Bayesian network meta-analysis; OP34; oral presentation; Feb. 18 ; 09:20-09:30 CET
• Pharmacokinetics and exposure-response analyses of upadacitinib in patients with moderate to severe ulcerative colitis – Analyses of induction and maintenance clinical trials; P341; poster session; Feb. 18 ; 12:30-13:30 CET
• Maintenance of health-related quality of life improvements with upadacitinib treatment among patients with moderately to severely active ulcerative colitis: results from 52-week Phase 3 study U ACHIEVE maintenance; P370; poster session; Feb. 18 ; 12:30-13:30 CET
• Correlation of histological assessment of mucosal healing with long-term clinical and patient-reported outcomes in patients with moderately to severely active ulcerative colitis treated with upadacitinib: results from the Phase 3 U-ACHIEVE maintenance trial; P521; poster session; Feb. 18 ; 12:30-13:30 CET
• Upadacitinib promotes histologic and endoscopic mucosal healing: Results from the upadacitinib ulcerative colitis Phase 3 Program; P522; poster session; Feb. 18 ; 12:30-13:30 CET
• The effect of multiple doses of upadacitinib 45 mg on the pharmacokinetics of cytochrome P450 substrates in healthy adult subjects; P556; poster session; Feb. 18 ; 12:30-13:30 CET
• The safety profile of upadacitinib maintenance therapy in ulcerative colitis in the Phase 3 U-ACHIEVE study is consistent with that in approved indications; P573; poster session; Feb. 18 ; 12:30-13:30 CET

Adalimumab Abstracts
Inflammatory Bowel Disease (IBD)

• Baseline whole-blood gene expression of TREM1 does not predict clinical or endoscopic outcomes following adalimumab treatment in patients with ulcerative colitis or Crohn's disease in the SERENE studies; DOP81; digital oral presentation; Feb. 18 ; 18:21-18:27 CET

Disease State Abstracts

• Trends in corticosteroid (CS) use over time and following diagnosis in patients with inflammatory bowel disease (IBD), using IBM ^® MarketScan ^® ; P488; poster session; Feb. 18 ; 8:00-18:00 CET

The full scientific program for 17 ^th Congress of ECCO is available here .

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

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 and abdominal pain. ^1-3 It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients. ^2,3 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. ⁴

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. ^2,6 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. ^2,7 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease. ⁸

About Risankizumab (SKYRIZI ^® )

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. ^9,10 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. ⁹ The approved dose for SKYRIZI for moderate to severe plaque psoriasis and active psoriatic arthritis in the European Union is 150 mg (either as two 75 mg pre-filled syringe injections or one 150 mg prefilled pen or pre-filled injections) administered by subcutaneous injections at week 0 and 4 and every 12 weeks thereafter. The use of risankizumab in Crohn's disease is not approved and its safety and efficacy have not been established by regulatory authorities. Phase 3 trials of SKYRIZI in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing. ^9,11-14

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. ^14-23 In human cellular assays, upadacitinib preferentially inhibits signalling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK-2. 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 is also 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 U.S. Food and Drug Administration (FDA) for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers as well as adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. RINVOQ 15 mg and 30 mg is approved for use in the U.S. 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. 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. ^14,16-22 The use of upadacitinib in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About HUMIRA ^® (adalimumab) in the European Union ²⁴

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

EU Indications and Important Safety Information about SKYRIZI ^® (risankizumab) ⁹

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).

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.

EU Indications and Important Safety Information about RINVOQ ^® (upadacitinib) ¹⁵

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.

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 .

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

EU Indications and Important Safety Information about HUMIRA ^® (adalimumab) ²⁴

Crohn's disease
HUMIRA is indicated for treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies

Ulcerative colitis
HUMIRA is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

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.

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 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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