AbbVie’s SKYRIZI® (Risankizumab) Receives European Commission Approval for Moderately to Severely Active Ulcerative Colitis

Jul 26, 2024 16:33 CST Updated 16:33

AbbVie

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▎Edited by the WuXi AppTec content team

Today (July 26), AbbVie (AbbVie) announced that the European CommissionApproved Skyrizi (risankizumab) for treatmentWith an inadequate response to, loss of response to, or intolerance to conventional or biologic therapiesAdult patients with moderately to severely active ulcerative colitis (UC)。Skyrizi isAbbVieInHeavyweight Product in the Field of Autoimmune Diseases, which has been approved for multiple indications in the United States and Europe.

Ulcerative colitis (UC) is an inflammatory bowel disease（IBD）, which can lead to gastrointestinal inflammation and potentially damage the colonic mucosa.According toIt is estimated that UC affects approximately 5 million people worldwide, and the incidence rate is continuously rising. Patients with this diseaseCommon signs and symptoms include diarrhea, abdominal pain, bloody stools, urgency to defecate, discharge of rectal mucus, and rectal pain and bleeding.

Risankizumab is a humanized, IgG1 subtype monoclonal antibody that selectively antagonizes IL-23 by binding to the p19 subunit of IL-23.IL-23 is a cytokine associated with inflammation and is considered to be linked to many chronic immune diseases. Previously, Skyrizi has been approved for multiple indications in the United States and the European Union, including Crohn's disease, moderate to severe plaque psoriasis, and active psoriatic arthritis in adults.AbbVieThe press release noted that the approval of this UC indication isSkyriziApproved in the EUThe FourthIndications.

SkyriziThe dosing regimen includes,During induction therapyPhase,Administered via intravenous (IV) injectionA dose of 1200mg was administered 3 times every 4 weeks for a total of 12 weeks.。Subsequently, the maintenance treatment phase was entered.Starting from week 12, a recommended maintenance dose of 180mg or 360mg is administered every 8 weeks via subcutaneous injection (SC), depending on the individual patient's response. Notably, AbbVie mentioned earlier in its press release,InAfter the induction therapy ends,Patients canUsing Intravenous Injection at HomeInjector (OBI) for treatment。OBI is a hands-free device designed for patients that can be adhered to the body and prepared according to instructions.It takes approximately 5 minutes to complete the administration.。

This time, SkyriziThe approval was based on two Phase 3 clinical trials, namely the INSPIRE inductionTrial and COMMAND MaintenanceTest.Among them, INSPIRE is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of 1200mg risankizumab administered intravenously (IV) at weeks 0, 4, and 8 as induction therapy for patients with moderate to severe active UC. COMMAND is a Phase 3, multicenter, randomized, double-blind, controlled, 52-week maintenance trial designed to evaluate 180mg or 360mg risankizumab.Subcutaneous Injection (SC)Efficacy and Safety in Adults with Moderate to Severe Active UC.

In two studies,SkyriziAll reached the primary endpoint of clinical remission.And key secondary endpoints。The results of the primary and key secondary endpoints of the trial include:

Primary Endpoint: Clinical Remission

In the INSPIRE trial, a significantly higher proportion of patients receiving 1200mg risankizumab intravenous therapy achieved the primary endpoint of clinical remission at week 12 compared to the placebo group (20% vs 6%).
In the COMMAND trial, participants received 180mg or 360mg of risankizumab.Subcutaneous injection (Patients treated with SC achieved clinical remission at Week 52 significantly more often than the control group: 40% and 38%, respectively, compared to 25% in the control group.

Key Secondary Endpoint: Mucosal Healing

In the INSPIRE trial, 37% of patients receiving 1200mg risankizumabIntravenous injection (IV) Treatment observed mucosal healing at week 12 in patients, while only 12% in the placebo group.Especially in previous biologic therapiesAmong patients who failed JAK inhibitor treatment, 48% of those receiving 1200 mg risankizumab IV achieved mucosal healing by week 12, compared to only 14% in the placebo group.
In the COMMAND trial, 51% of patients received 180mgrisankizumabTreated patients and 48% of those receiving 360mgrisankizumabPatients treated achieved mucosal healing at week 52, compared to 32% in the control group.In patients who had previously failed biotherapy or JAK inhibitor treatment, 60% of those receiving 180mg risankizumab and 76% of those receiving 360mg risankizumab achieved mucosal healing, compared to 36% in the control group.

Key Secondary Endpoint: Histologic Endoscopic Mucosal Healing (HEMH)

In the INSPIRE trial, 24% of patients receiving 1200mg risankizumab intravenously achieved HEMH at week 12, compared to only 8% in the placebo group.
In the COMMAND trial, significantly more patients receiving 180mg and 360mg risankizumab achieved HEMH at week 52 compared to the control group: 43% and 42%, vs 23%.

Investigators of the INSPIRE TrialEdoProfessor Guard Louis stated:"Ulcerative colitis is a chronic, unpredictable, and sometimes debilitating disease that requires ongoing symptom relief for patients."In the INSPIRE trial and COMMAND trial, participants receivedSkyriziPatients treated have shown significant improvement in clinical remission and mucosal healing.These are important findings because mucosal healing goes beyond symptom management and involves the restoration of the intestinal wall, which is associated with improved long-term outcomes. This approval will introduce a new treatment option to help UC patients achieve their long-term therapeutic goals."

Risankizumab isBoehringer Ingelheim (As part of the collaboration between Boehringer Ingelheim and AbbVie, AbbVie is responsible for its global development and commercialization.In China,AbbVie Inc. submitted in July 2023Risankizumab (risankizumab）Injection SolutionAnd the marketing application for its subcutaneous injectable formulation has been accepted by the China National Medical Products Administration (NMPA).

References:
[1]AbbVie Announces European Commission Approval of SKYRIZI® (risankizumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis. Retrieved Jul 26，2024, From https://news.abbvie.com/2024-07-26-AbbVie-Announces-European-Commission-Approval-of-SKYRIZI-R-risankizumab-for-the-Treatment-of-Adults-with-Moderately-to-Severely-Active-Ulcerative-Colitis

[2] FDA Approves SKYRIZI® for the Treatment of Ulcerative Colitis, AbbVie Expands Its Product Portfolio in the Inflammatory Bowel Disease Field.Retrieved Jul 26，2024, from https://mp.weixin.qq.com/s/WnNJWFBryakfoiJKlo_Eag

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