Updates: New late-breaking data evaluates efficacy and safety of 52-week maintenance studies in risankizumab (SKYRIZI®) in patients with Crohn’s disease

“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 [email protected] or [email protected] 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 Union25

 

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