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NORTH CHICAGO, Ill., June 28, 2021 /PRNewswire/ -- AbbVie today announced new data on upadacitinib (RINVOQ®) in ulcerative colitis and risankizumab (SKYRIZI®) in Crohn's disease will be presented as oral presentations at the 16th Congress of European Crohn's and Colitis Organisation (ECCO), to be held virtually July 2-3 and July 8-10. AbbVie is presenting a total of nine abstracts, five of which are oral presentations, across a broad range of studies in inflammatory bowel diseases (IBD).
"We know many people with IBD are still suffering with the debilitating effects of their disease," said Remo Panaccione, M.D., professor of medicine and director of the IBD unit, University of Calgary. "AbbVie's robust research on display at ECCO highlights meaningful developments that have the potential to positively impact the lives and improve the standards of care for people living with gastrointestinal diseases, including ulcerative colitis and Crohn's disease."
Two separate oral presentations will feature data from the pivotal Phase 3 induction studies evaluating the efficacy and safety of upadacitinib (45 mg, once daily) as induction therapy in patients with moderate to severe ulcerative colitis. These studies, U-ACHIEVE and U-ACCOMPLISH, will highlight the impact of upadacitinib on clinical, endoscopic and histologic outcomes after 8 weeks of treatment. Top-line results from these studies were previously announced in December 2020 and February 2021, respectively.
Data from the global Phase 3 program evaluating risankizumab in adults with moderate to severe Crohn's disease will be presented as three separate oral presentations. Phase 3 induction studies, ADVANCE and MOTIVATE, for risankizumab (600 mg or 1200 mg) evaluated clinical remission and response and improvements in endoscopic outcomes at week 12. The third oral presentation from ADVANCE AND MOTIVATE will highlight the impact of risankizumab induction therapy on patient-reported outcomes. Top-line results from these studies were previously announced in January 2021.
In addition, several presentations will focus on advancing research surrounding the importance of understanding patient preferences and the impact of patient-reported outcomes. In partnership with the European Federation of Crohn's & Ulcerative Colitis Associations (EFCCA), AbbVie will present results from the P-POWER IBD study that evaluated clinical outcomes and challenges in patients with IBD.
"This study investigated how difficult it is for patients to manage their IBD," said Salvo Leone, chairman of EFCCA. "Patients are seeking further treatment options to control the unpredictability of this disease and its debilitating impact on their daily lives."
Results from the ICONIC study will also be presented, evaluating the correlation between patient-reported outcomes and patient-reported disease activity in ulcerative colitis.
AbbVie abstracts in the 16th Congress of ECCO programme include:
Upadacitinib Abstracts Ulcerative Colitis (UC)
Risankizumab Abstracts Crohn's Disease (CD)
Disease State Abstracts
The full scientific programme for the 16th 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 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.1,2 The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.1,3 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.2,4 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease.5
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.2,6-7 It is a progressive disease, meaning it gets worse over time.2,7 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.5
About Upadacitinib (RINVOQ®)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.8-15 In human cellular assays, RINVOQ preferentially inhibits signalling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.8 In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs); for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs; and for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy. The approved dose for RINVOQ is 15 mg. Phase 3 trials of RINVOQ in atopic dermatitis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.9-15 Use of RINVOQ in ulcerative colitis is not approved and its safety and efficacy are under evaluation 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.16,17 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.16 In April 2019, SKYRIZI received U.S. Food and Drug Administration approval for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The approved dose for SKYRIZI is 150 mg, 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.18-20 Use of SKYRIZI in Crohn's disease is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
Important EU Safety Information about RINVOQ® (upadacitinib)8
RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.
Use in combination with other potent immunosuppressants is not recommended.
Serious and sometimes fatal infections have been reported in patients receiving upadacitinib. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis have been reported. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/oesophageal candidiasis, and cryptococcosis have been reported with upadacitinib. Prior to initiating upadacitinib, consider the risks and benefits of treatment in patients with chronic or recurrent infection or with a history of a serious or opportunistic infection, in patients who have been exposed to TB or have resided or travelled in areas of endemic TB or endemic mycoses, and in patients with underlying conditions that may predispose them to infection. Upadacitinib therapy should be interrupted if a patient develops a serious or opportunistic infection. As there is a higher incidence of infections in patients ≥65 years of age, caution should be used when treating this population.
Patients should be screened for TB before starting upadacitinib therapy. Anti-TB therapy should be considered prior to initiation of upadacitinib in patients with previously untreated latent TB or in patients with risk factors for TB infection.
Viral reactivation, including cases of herpes zoster, were reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with upadacitinib. Consider interruption of therapy if a patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should be performed before starting and during therapy with upadacitinib.
The use of live, attenuated vaccines during, or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating upadacitinib, in agreement with current immunization guidelines.
The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis (RA). Immunomodulatory medicinal products may increase the risk of malignancies, including lymphoma. The clinical data are currently limited and long-term studies are ongoing. Malignancies, including non-melanoma skin cancer (NMSC), have been reported in patients treated with upadacitinib. Consider the risks and benefits of upadacitinib treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated NMSC or when considering continuing upadacitinib therapy in patients who develop a malignancy. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
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