- Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical remission (per Adapted Mayo Score) and key secondary endpoints as an induction and maintenance treatment1,2
- Safety results were generally consistent with the known safety profile of risankizumab, with no new safety risks observed1,2
- Risankizumab is an IL-23 inhibitor being evaluated as a treatment for adults with moderately to severely active ulcerative colitis and is currently approved by FDA and EMA in Crohn’s disease, psoriatic arthritis and psoriasis1
NORTH CHICAGO, IL, USA I August 28, 2023 I AbbVie (NYSE: ABBV) today announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for risankizumab (SKYRIZI®, 1200 mg intravenous [IV] [induction dose] and 180 mg and 360 mg subcutaneous [SC] [maintenance dose]) for the treatment of adult patients with moderately to severely active ulcerative colitis.
“While there has been advancement in therapies to treat ulcerative colitis, there is still an ongoing need for additional treatments to help those seeking relief from its disruptive effects,” said Roopal Thakkar, M.D., senior vice president, development, regulatory affairs and chief medical officer, AbbVie. “These submissions demonstrate our continued commitment to helping people living with IBD, and we look forward to providing a potential new treatment option for the management of ulcerative colitis.”
Applications to the FDA and EMA are supported by data from two Phase 3 clinical trials: an induction study, INSPIRE, and a maintenance study, COMMAND.1,2 Significantly more patients treated with risankizumab 1200 mg IV at week 12 in the induction study and 180 mg or 360 mg SC at week 52 in the maintenance study achieved the primary endpoint of clinical remission (per Adapted Mayo Score), compared to patients receiving placebo.1,2 Additionally, more risankizumab-treated patients in both the induction and maintenance studies achieved the key secondary endpoints of endoscopic improvement (endoscopic subscore ≤1 without evidence of friability) and histologic endoscopic mucosal improvement (HEMI, defined as endoscopic subscore ≤1 without evidence of friability and Geboes score ≤3.1) compared to placebo.1,2
The safety results in INSPIRE and COMMAND were generally consistent with the safety profile of risankizumab observed in previous studies across other indications, with no new safety risks observed.1,2
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.3,4 The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.3,4 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 life-threatening complications.5,6 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease.7
About INSPIRE Induction Study1
INSPIRE is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of risankizumab 1200 mg IV administered every four weeks as induction therapy in subjects with moderately to severely active ulcerative colitis.
The primary endpoint is clinical remission (per adapted Mayo Score, defined as SFS ≤1 and not greater than baseline, RBS of 0 and endoscopic subscore ≤1 without friability) at week 12. Key secondary endpoints include clinical response (decrease from baseline in the Adapted Mayo score ≥2 points and ≥30% from baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1), endoscopic improvement (endoscopic subscore ≤1 without friability), and HEMI (endoscopic subscore of 0 or 1 without friability and Geboes score ≤3.1) at week 12.
Topline results of the study were shared in March 2023. More information can be found on www.clinicaltrials.gov (NCT03398148).
About COMMAND Maintenance Study2
The COMMAND study is a Phase 3, multicenter, randomized, double-blind, controlled, 52-week maintenance study designed to evaluate the efficacy and safety of risankizumab 180 mg or 360 mg SC in adults with moderately to severely active ulcerative colitis. This study had a re-randomized withdrawal design in which all patients received risankizumab IV induction and those who responded to risankizumab were re-randomized to receive risankizumab 180 mg or 360 mg SC or withdrawal from risankizumab treatment (induction-only control group). For those randomized to the withdrawal from risankizumab treatment (induction-only control group), the rest of the study duration was a risankizumab washout. The objective of the Phase 3 study is to evaluate the efficacy and safety of risankizumab 180 mg or 360 mg as maintenance therapy versus withdrawal from risankizumab treatment (control) in patients with moderately to severely active ulcerative colitis who responded to risankizumab IV induction in the INSPIRE study.
The primary endpoint is clinical remission (per Adapted Mayo Score, defined as SFS ≤1 and not greater than baseline, RBS of 0 and endoscopic subscore ≤1 without evidence of friability) at week 52. Key secondary endpoints include endoscopic improvement (endoscopic subscore ≤1 without evidence of friability), HEMI (endoscopic subscore of ≤1 without evidence of friability and Geboes score ≤3.1), and steroid-free clinical remission (defined as clinical remission per Adapted Mayo Score at week 52 and corticosteroid free for ≥90 days prior to week 52) at week 52.
Topline results from this study were shared in June 2023. More information can be found on www.clinicaltrials.gov (NCT03398135).
About Risankizumab (SKYRIZI®)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.8 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.9 SKYRIZI is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease. The use of risankizumab in ulcerative colitis is not approved and its safety and efficacy have not been established by regulatory authorities. Phase 3 trials of risankizumab in psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis are ongoing.9-11
U.S. Indications and Important Safety Information about SKYRIZI® (risankizumab-rzaa)12
SKYRIZI is a prescription medicine used to treat adults with:
- moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
- active psoriatic arthritis (PsA).
- moderate to severe Crohn’s disease.
Please click here for Full Prescribing Information and Medication Guide for SKYRIZI.
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 and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
References:
- AbbVie. Data on File: ABVRRTI75696.
- AbbVie. Data on file: ABVRRTI76012.
- Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive review and update on ulcerative colitis. Dis Mon. 2019;65(12):100851. doi:10.1016/j.disamonth.2019.02.004
- The facts about inflammatory bowel diseases. Crohn’s & Colitis Foundation of America. Accessed March 8, 2023. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
- Ulcerative colitis. Mayo Clinic. Accessed March 3, 2023. https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326
- Surgery for Crohn’s Disease and Ulcerative Colitis. Crohn’s & Colitis Foundation of America. Accessed August 21, 2023. https://www.crohnscolitisfoundation.org/sites/default/files/legacy/assets/pdfs/surgery_brochure_final.pdf
- Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016;22(3 Suppl):s51-60.
- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf. Accessed on August 21, 2023.
- Pipeline. AbbVie. Accessed March 3, 2023. https://www.abbvie.com/our-science/pipeline.html
- A study comparing risankizumab to placebo in participants with active psoriatic arthritis including those who have a history of inadequate response or intolerance to biologic therapy(ies) (KEEPsAKE2). ClinicalTrials.gov. Updated February 28, 2023. Accessed March 3, 2023. https://clinicaltrials.gov/ct2/show/NCT03671148
- A multicenter, randomized, double-blind, placebo controlled induction study to evaluate the efficacy and safety of risankizumab in participants with moderately to severely active ulcerative colitis. ClinicalTrials.gov. Updated March 10, 2023. Accessed March 12, 2023. https://clinicaltrials.gov/ct2/show/record/NCT03398148
- SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.; 2022.
SOURCE: AbbVie
Post Views: 329
- Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical remission (per Adapted Mayo Score) and key secondary endpoints as an induction and maintenance treatment1,2
- Safety results were generally consistent with the known safety profile of risankizumab, with no new safety risks observed1,2
- Risankizumab is an IL-23 inhibitor being evaluated as a treatment for adults with moderately to severely active ulcerative colitis and is currently approved by FDA and EMA in Crohn’s disease, psoriatic arthritis and psoriasis1
NORTH CHICAGO, IL, USA I August 28, 2023 I AbbVie (NYSE: ABBV) today announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for risankizumab (SKYRIZI®, 1200 mg intravenous [IV] [induction dose] and 180 mg and 360 mg subcutaneous [SC] [maintenance dose]) for the treatment of adult patients with moderately to severely active ulcerative colitis.
“While there has been advancement in therapies to treat ulcerative colitis, there is still an ongoing need for additional treatments to help those seeking relief from its disruptive effects,” said Roopal Thakkar, M.D., senior vice president, development, regulatory affairs and chief medical officer, AbbVie. “These submissions demonstrate our continued commitment to helping people living with IBD, and we look forward to providing a potential new treatment option for the management of ulcerative colitis.”
Applications to the FDA and EMA are supported by data from two Phase 3 clinical trials: an induction study, INSPIRE, and a maintenance study, COMMAND.1,2 Significantly more patients treated with risankizumab 1200 mg IV at week 12 in the induction study and 180 mg or 360 mg SC at week 52 in the maintenance study achieved the primary endpoint of clinical remission (per Adapted Mayo Score), compared to patients receiving placebo.1,2 Additionally, more risankizumab-treated patients in both the induction and maintenance studies achieved the key secondary endpoints of endoscopic improvement (endoscopic subscore ≤1 without evidence of friability) and histologic endoscopic mucosal improvement (HEMI, defined as endoscopic subscore ≤1 without evidence of friability and Geboes score ≤3.1) compared to placebo.1,2
The safety results in INSPIRE and COMMAND were generally consistent with the safety profile of risankizumab observed in previous studies across other indications, with no new safety risks observed.1,2
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.3,4 The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.3,4 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 life-threatening complications.5,6 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease.7
About INSPIRE Induction Study1
INSPIRE is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of risankizumab 1200 mg IV administered every four weeks as induction therapy in subjects with moderately to severely active ulcerative colitis.
The primary endpoint is clinical remission (per adapted Mayo Score, defined as SFS ≤1 and not greater than baseline, RBS of 0 and endoscopic subscore ≤1 without friability) at week 12. Key secondary endpoints include clinical response (decrease from baseline in the Adapted Mayo score ≥2 points and ≥30% from baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1), endoscopic improvement (endoscopic subscore ≤1 without friability), and HEMI (endoscopic subscore of 0 or 1 without friability and Geboes score ≤3.1) at week 12.
Topline results of the study were shared in March 2023. More information can be found on www.clinicaltrials.gov (NCT03398148).
About COMMAND Maintenance Study2
The COMMAND study is a Phase 3, multicenter, randomized, double-blind, controlled, 52-week maintenance study designed to evaluate the efficacy and safety of risankizumab 180 mg or 360 mg SC in adults with moderately to severely active ulcerative colitis. This study had a re-randomized withdrawal design in which all patients received risankizumab IV induction and those who responded to risankizumab were re-randomized to receive risankizumab 180 mg or 360 mg SC or withdrawal from risankizumab treatment (induction-only control group). For those randomized to the withdrawal from risankizumab treatment (induction-only control group), the rest of the study duration was a risankizumab washout. The objective of the Phase 3 study is to evaluate the efficacy and safety of risankizumab 180 mg or 360 mg as maintenance therapy versus withdrawal from risankizumab treatment (control) in patients with moderately to severely active ulcerative colitis who responded to risankizumab IV induction in the INSPIRE study.
The primary endpoint is clinical remission (per Adapted Mayo Score, defined as SFS ≤1 and not greater than baseline, RBS of 0 and endoscopic subscore ≤1 without evidence of friability) at week 52. Key secondary endpoints include endoscopic improvement (endoscopic subscore ≤1 without evidence of friability), HEMI (endoscopic subscore of ≤1 without evidence of friability and Geboes score ≤3.1), and steroid-free clinical remission (defined as clinical remission per Adapted Mayo Score at week 52 and corticosteroid free for ≥90 days prior to week 52) at week 52.
Topline results from this study were shared in June 2023. More information can be found on www.clinicaltrials.gov (NCT03398135).
About Risankizumab (SKYRIZI®)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.8 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.9 SKYRIZI is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease. The use of risankizumab in ulcerative colitis is not approved and its safety and efficacy have not been established by regulatory authorities. Phase 3 trials of risankizumab in psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis are ongoing.9-11
U.S. Indications and Important Safety Information about SKYRIZI® (risankizumab-rzaa)12
SKYRIZI is a prescription medicine used to treat adults with:
- moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
- active psoriatic arthritis (PsA).
- moderate to severe Crohn’s disease.
Please click here for Full Prescribing Information and Medication Guide for SKYRIZI.
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 and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
References:
- AbbVie. Data on File: ABVRRTI75696.
- AbbVie. Data on file: ABVRRTI76012.
- Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive review and update on ulcerative colitis. Dis Mon. 2019;65(12):100851. doi:10.1016/j.disamonth.2019.02.004
- The facts about inflammatory bowel diseases. Crohn’s & Colitis Foundation of America. Accessed March 8, 2023. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
- Ulcerative colitis. Mayo Clinic. Accessed March 3, 2023. https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326
- Surgery for Crohn’s Disease and Ulcerative Colitis. Crohn’s & Colitis Foundation of America. Accessed August 21, 2023. https://www.crohnscolitisfoundation.org/sites/default/files/legacy/assets/pdfs/surgery_brochure_final.pdf
- Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016;22(3 Suppl):s51-60.
- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf. Accessed on August 21, 2023.
- Pipeline. AbbVie. Accessed March 3, 2023. https://www.abbvie.com/our-science/pipeline.html
- A study comparing risankizumab to placebo in participants with active psoriatic arthritis including those who have a history of inadequate response or intolerance to biologic therapy(ies) (KEEPsAKE2). ClinicalTrials.gov. Updated February 28, 2023. Accessed March 3, 2023. https://clinicaltrials.gov/ct2/show/NCT03671148
- A multicenter, randomized, double-blind, placebo controlled induction study to evaluate the efficacy and safety of risankizumab in participants with moderately to severely active ulcerative colitis. ClinicalTrials.gov. Updated March 10, 2023. Accessed March 12, 2023. https://clinicaltrials.gov/ct2/show/record/NCT03398148
- SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.; 2022.
SOURCE: AbbVie
Post Views: 329
