– Seventh approved indication for RINVOQ in the European Union (EU) and the first and only oral Janus Kinase (JAK) inhibitor approved to treat adult patients with moderately to severely active Crohn’s disease
– Third gastroenterology indication approved across AbbVie’s Inflammatory Bowel Disease portfolio in less than a year
– A significantly higher proportion of patients treated with RINVOQ achieved the co-primary endpoints of endoscopic response and clinical remission and the key secondary endpoint of corticosteroid-free clinical remission at weeks 12 and 52 compared to placebo1-4; safety results in Crohn’s disease were generally consistent with the known safety profile of RINVOQ1,5-9
– Crohn’s disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract and is progressive, potentially producing complications that require urgent medical care, including surgery10,11
NORTH CHICAGO, IL, USA I April 17, 2023 I AbbVie (NYSE: ABBV) today announced the European Commission (EC) approved RINVOQ® (upadacitinib, 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) as the first oral Janus Kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.1-4
“The EC approval of RINVOQ in Crohn’s disease is a significant milestone in offering patients the first and only once-daily oral treatment that can provide endoscopic improvement, and sustained symptom relief, making a difference in their daily lives,” said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. “With existing therapies, not all patients are able to achieve adequate disease control to meet their treatment goals, which is why we continue to embrace the challenge of expanding our IBD portfolio with new treatment options.”
The EC approval is supported by data from two induction studies, U-EXCEED and U-EXCEL, and the U-ENDURE maintenance study.1 Statistical significance was achieved for the co-primary endpoints and key secondary endpoints with RINVOQ 45 mg in the induction studies and RINVOQ 15 mg and 30 mg in the maintenance study compared to placebo.1-4
Co-Primary Endpoint Results from the Phase 3 program include1-4:
- Endoscopic response*: In U-EXCEED and U-EXCEL, 35% and 46% of patients treated with RINVOQ 45 mg achieved endoscopic response at week 12, respectively, compared to 4% and 13% of patients receiving placebo.1 In U-ENDURE, 28% and 40% of patients treated with RINVOQ 15 mg and 30 mg achieved endoscopic response at week 52, respectively, compared to 7% of patients receiving placebo.1
- Clinical remission†: In U-EXCEED and U-EXCEL, 40% and 51% of patients treated with RINVOQ 45 mg achieved clinical remission at 12 weeks, respectively, compared to 14% and 22% of patients receiving placebo.1 Additionally, in U-ENDURE, 36% and 46% patients treated with RINVOQ 15 mg and 30 mg achieved clinical remission at 52 weeks, respectively, compared to 14% of patients receiving placebo.1
Key Secondary and Additional Endpoints include:
- Corticosteroid-free clinical remission‡: In U-EXCEED and U-EXCEL, 37% and 44% of patients treated with RINVOQ 45 mg achieved steroid-free remission at week 12, respectively, compared to 7% and 13% of patients receiving placebo. In U-ENDURE, 35% and 45% of patients treated with RINVOQ 15 mg and 30 mg achieved steroid-free remission at week 52, respectively, compared to 14% of patients receiving placebo.1
- Mucosal healing§: Additionally, in U-EXCEED and U-EXCEL, 17% and 25% of patients treated with RINVOQ 45mg achieved SES-CD ulcerated surface subscore of 0 at week 12, respectively, compared to 0% and 5% of patients receiving placebo. In U-ENDURE, 13% and 24% of patients treated with RINVOQ 15 mg and 30 mg achieved SES-CD ulcerated surface subscore of 0 at week 52 compared to 4% of patients receiving placebo (all with nominal p-value<0.001).1
“Crohn’s disease is a burden that can present patients with daily, often uncomfortable challenges,” said Laurent Peyrin-Biroulet, M.D., Ph.D., professor of gastroenterology and head of the Inflammatory Bowel Disease group at the Gastroenterology Department, University Hospital of Nancy, France. “These studies demonstrated RINVOQ’s ability to achieve key treatment targets, including endoscopic outcomes and symptomatic relief, that are critical for patients and beneficial for long-term care.”
The safety profile of RINVOQ in Crohn’s disease was generally consistent with the known safety profile of RINVOQ.1-4 Similar rates of serious adverse events including serious infections, were observed between patients receiving RINVOQ and placebo.1-4 The most common adverse events included nasopharyngitis, acne and COVID-19 in the RINVOQ treatment group.1-4 Reports of malignancy, major cardiovascular events, venous thromboembolic events and gastrointestinal perforation were infrequently observed (<1.0 Events/100 Patient-Years).
RINVOQ is approved in the EU for the treatment of adults with radiographic axial spondyloarthritis, non-radiographic axial spondyloarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, adults and adolescents with atopic dermatitis and now Crohn’s disease.1,5-9
About Crohn’s Disease
Crohn’s disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain.10,11It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients or may develop complications that require urgent medical care, including surgery.10,11 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.10,11
About the U-EXCEED and U-EXCEL Inductions Studies, and the U-ENDURE Maintenance Study1-4
The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of RINVOQ 45 mg as induction therapy and RINVOQ 15 mg and 30 mg as maintenance therapy in patients with moderately to severely active Crohn’s disease. Topline results of the U-EXCEED and U-EXCEL induction studies were announced in December 2021 and February 2022. Topline results of the U-ENDURE maintenance study were announced in May 2022. More information can be found on www.clinicaltrials.gov (U-EXCEED: NCT03345836 , U-EXCEL: NCT03345849 , U-ENDURE: NCT03345823).
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible Janus Kinase (JAK) inhibitor.1 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.1
Phase 3 trials of upadacitinib (RINVOQ) in giant cell arteritis and Takayasu arteritis are ongoing.1,12-14
EU Indications and Important Safety Information about RINVOQ® (upadacitinib)1
Indications
Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) 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 (PsA) 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.
Axial spondyloarthritis
Non-radiographic axial spondyloarthritis (nr-axSpA)
RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
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 (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.
Ulcerative colitis
RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Crohn’s disease
RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
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.
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 our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.
References:
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; March 2023. https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf
- Colombel JF, Panes J, Lacerda AP, Peyrin-Biroulet L. Efficacy and safety of upadacitinib induction therapy in patients with moderately to severely active Crohn’s disease who failed prior biologics: results form a randomized phase 3 U-EXCEED study. Gastroenterology. 2022;162(7):S-1394. doi:10.1016/S0016-5085(22)64061-7
- Loftus EV, Colombel LF, Lacerda AP, et al. Efficacy and safety of upadacitinib induction therapy in patients with moderately to severely active Crohn’s disease: results from a randomized phase 3 U-EXCEL study. United European Gastroenterol J. 2022;10(8):103-104. doi: 10.1002/ueg2.12293.
- Panes J, Loftus E, Lacerda AP, Peyrin-Biroulet L, D’Haens G, Panaccione R. Efficacy and safety of upadacitinib maintenance therapy in patients with moderately to severely active Crohn’s disease: results from a randomized phase 3 U-ENDURE maintenance study. American College of Gastroenterology. 2022;1-14.
- Guttman-Yassky E, Teixeira HD, Simpson EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021;397(10290):2151-2168. doi:10.1016/S0140-6736(21)00588-2
- Cohen SB, van Vollenhoven RF, Winthrop KL, et al. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. [published correction appears in Ann Rheum Dis. 2021 May;80(5):e83]. Ann Rheum Dis. 2021;80(3):304-311. doi:10.1136/annrheumdis-2020-218510
- van der Heijde D, Song IH, Pangan AL, et al. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial. Lancet. 2019;394(10214):2108-2117. doi:10.1016/S0140-6736(19)32534-6
- Mease PJ, Lertratanakul A, Anderson JK, et al. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2021;80(3):312-320. doi:10.1136/annrheumdis-2020-218870
- Danese, S, Vermeire, S, Zhou, W, et al. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5.
- Crohn’s disease. Symptoms and causes. Mayo Clinic. Accessed March 8, 2023. https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304
- 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
- Pipeline. AbbVie. Accessed March 3, 2023. https://www.abbvie.com/our-science/pipeline.html
- A study to evaluate the safety and efficacy of upadacitinib in participants with giant cell arteritis (SELECT-GCA). ClinicalTrials.gov. 2022. Updated March 21, 2023. Accessed March 21, 2023. https://clinicaltrials.gov/ct2/show/NCT03725202
- A study to evaluate the efficacy and safety of upadacitinib in participants with Takayasu arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. Updated November 28, 2022. Accessed March 6, 2023. https://clinicaltrials.gov/ct2/show/NCT04161898
* Endoscopic response is defined as a decrease in simple endoscopic score for Crohn’s disease (SES-CD) of >50% from baseline (or at least a 2-point reduction from baseline in patients with a baseline score of 4) of the induction.
† Clinical remission per SF/AP is defined as average daily very soft or liquid stool frequency ≤2.8 AND abdominal pain score ≤1.0 and neither greater than baseline.
‡ Corticosteroid-free clinical remission is defined as discontinuation of corticosteroid and achievement of clinical remission among subjects on corticosteroid at baseline in the induction studies and is defined as without corticosteroid use for 90 days and achievement of clinical remission in the maintenance study.
§ Mucosal healing is defined as SES-CD ulcerated surface subscore of 0 in patients with SES-CD ulcerated surface subscore ≥ 1 at baseline. Mucosal healing was a prespecified endpoint, not controlled for multiplicity.
SOURCE: AbbVie
Post Views: 83
– Seventh approved indication for RINVOQ in the European Union (EU) and the first and only oral Janus Kinase (JAK) inhibitor approved to treat adult patients with moderately to severely active Crohn’s disease
– Third gastroenterology indication approved across AbbVie’s Inflammatory Bowel Disease portfolio in less than a year
– A significantly higher proportion of patients treated with RINVOQ achieved the co-primary endpoints of endoscopic response and clinical remission and the key secondary endpoint of corticosteroid-free clinical remission at weeks 12 and 52 compared to placebo1-4; safety results in Crohn’s disease were generally consistent with the known safety profile of RINVOQ1,5-9
– Crohn’s disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract and is progressive, potentially producing complications that require urgent medical care, including surgery10,11
NORTH CHICAGO, IL, USA I April 17, 2023 I AbbVie (NYSE: ABBV) today announced the European Commission (EC) approved RINVOQ® (upadacitinib, 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) as the first oral Janus Kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.1-4
“The EC approval of RINVOQ in Crohn’s disease is a significant milestone in offering patients the first and only once-daily oral treatment that can provide endoscopic improvement, and sustained symptom relief, making a difference in their daily lives,” said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. “With existing therapies, not all patients are able to achieve adequate disease control to meet their treatment goals, which is why we continue to embrace the challenge of expanding our IBD portfolio with new treatment options.”
The EC approval is supported by data from two induction studies, U-EXCEED and U-EXCEL, and the U-ENDURE maintenance study.1 Statistical significance was achieved for the co-primary endpoints and key secondary endpoints with RINVOQ 45 mg in the induction studies and RINVOQ 15 mg and 30 mg in the maintenance study compared to placebo.1-4
Co-Primary Endpoint Results from the Phase 3 program include1-4:
- Endoscopic response*: In U-EXCEED and U-EXCEL, 35% and 46% of patients treated with RINVOQ 45 mg achieved endoscopic response at week 12, respectively, compared to 4% and 13% of patients receiving placebo.1 In U-ENDURE, 28% and 40% of patients treated with RINVOQ 15 mg and 30 mg achieved endoscopic response at week 52, respectively, compared to 7% of patients receiving placebo.1
- Clinical remission†: In U-EXCEED and U-EXCEL, 40% and 51% of patients treated with RINVOQ 45 mg achieved clinical remission at 12 weeks, respectively, compared to 14% and 22% of patients receiving placebo.1 Additionally, in U-ENDURE, 36% and 46% patients treated with RINVOQ 15 mg and 30 mg achieved clinical remission at 52 weeks, respectively, compared to 14% of patients receiving placebo.1
Key Secondary and Additional Endpoints include:
- Corticosteroid-free clinical remission‡: In U-EXCEED and U-EXCEL, 37% and 44% of patients treated with RINVOQ 45 mg achieved steroid-free remission at week 12, respectively, compared to 7% and 13% of patients receiving placebo. In U-ENDURE, 35% and 45% of patients treated with RINVOQ 15 mg and 30 mg achieved steroid-free remission at week 52, respectively, compared to 14% of patients receiving placebo.1
- Mucosal healing§: Additionally, in U-EXCEED and U-EXCEL, 17% and 25% of patients treated with RINVOQ 45mg achieved SES-CD ulcerated surface subscore of 0 at week 12, respectively, compared to 0% and 5% of patients receiving placebo. In U-ENDURE, 13% and 24% of patients treated with RINVOQ 15 mg and 30 mg achieved SES-CD ulcerated surface subscore of 0 at week 52 compared to 4% of patients receiving placebo (all with nominal p-value<0.001).1
“Crohn’s disease is a burden that can present patients with daily, often uncomfortable challenges,” said Laurent Peyrin-Biroulet, M.D., Ph.D., professor of gastroenterology and head of the Inflammatory Bowel Disease group at the Gastroenterology Department, University Hospital of Nancy, France. “These studies demonstrated RINVOQ’s ability to achieve key treatment targets, including endoscopic outcomes and symptomatic relief, that are critical for patients and beneficial for long-term care.”
The safety profile of RINVOQ in Crohn’s disease was generally consistent with the known safety profile of RINVOQ.1-4 Similar rates of serious adverse events including serious infections, were observed between patients receiving RINVOQ and placebo.1-4 The most common adverse events included nasopharyngitis, acne and COVID-19 in the RINVOQ treatment group.1-4 Reports of malignancy, major cardiovascular events, venous thromboembolic events and gastrointestinal perforation were infrequently observed (<1.0 Events/100 Patient-Years).
RINVOQ is approved in the EU for the treatment of adults with radiographic axial spondyloarthritis, non-radiographic axial spondyloarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, adults and adolescents with atopic dermatitis and now Crohn’s disease.1,5-9
About Crohn’s Disease
Crohn’s disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain.10,11It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients or may develop complications that require urgent medical care, including surgery.10,11 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.10,11
About the U-EXCEED and U-EXCEL Inductions Studies, and the U-ENDURE Maintenance Study1-4
The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of RINVOQ 45 mg as induction therapy and RINVOQ 15 mg and 30 mg as maintenance therapy in patients with moderately to severely active Crohn’s disease. Topline results of the U-EXCEED and U-EXCEL induction studies were announced in December 2021 and February 2022. Topline results of the U-ENDURE maintenance study were announced in May 2022. More information can be found on www.clinicaltrials.gov (U-EXCEED: NCT03345836 , U-EXCEL: NCT03345849 , U-ENDURE: NCT03345823).
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible Janus Kinase (JAK) inhibitor.1 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.1
Phase 3 trials of upadacitinib (RINVOQ) in giant cell arteritis and Takayasu arteritis are ongoing.1,12-14
EU Indications and Important Safety Information about RINVOQ® (upadacitinib)1
Indications
Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) 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 (PsA) 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.
Axial spondyloarthritis
Non-radiographic axial spondyloarthritis (nr-axSpA)
RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
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 (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.
Ulcerative colitis
RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Crohn’s disease
RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
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.
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 our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.
References:
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; March 2023. https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf
- Colombel JF, Panes J, Lacerda AP, Peyrin-Biroulet L. Efficacy and safety of upadacitinib induction therapy in patients with moderately to severely active Crohn’s disease who failed prior biologics: results form a randomized phase 3 U-EXCEED study. Gastroenterology. 2022;162(7):S-1394. doi:10.1016/S0016-5085(22)64061-7
- Loftus EV, Colombel LF, Lacerda AP, et al. Efficacy and safety of upadacitinib induction therapy in patients with moderately to severely active Crohn’s disease: results from a randomized phase 3 U-EXCEL study. United European Gastroenterol J. 2022;10(8):103-104. doi: 10.1002/ueg2.12293.
- Panes J, Loftus E, Lacerda AP, Peyrin-Biroulet L, D’Haens G, Panaccione R. Efficacy and safety of upadacitinib maintenance therapy in patients with moderately to severely active Crohn’s disease: results from a randomized phase 3 U-ENDURE maintenance study. American College of Gastroenterology. 2022;1-14.
- Guttman-Yassky E, Teixeira HD, Simpson EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021;397(10290):2151-2168. doi:10.1016/S0140-6736(21)00588-2
- Cohen SB, van Vollenhoven RF, Winthrop KL, et al. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. [published correction appears in Ann Rheum Dis. 2021 May;80(5):e83]. Ann Rheum Dis. 2021;80(3):304-311. doi:10.1136/annrheumdis-2020-218510
- van der Heijde D, Song IH, Pangan AL, et al. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial. Lancet. 2019;394(10214):2108-2117. doi:10.1016/S0140-6736(19)32534-6
- Mease PJ, Lertratanakul A, Anderson JK, et al. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2021;80(3):312-320. doi:10.1136/annrheumdis-2020-218870
- Danese, S, Vermeire, S, Zhou, W, et al. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5.
- Crohn’s disease. Symptoms and causes. Mayo Clinic. Accessed March 8, 2023. https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304
- 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
- Pipeline. AbbVie. Accessed March 3, 2023. https://www.abbvie.com/our-science/pipeline.html
- A study to evaluate the safety and efficacy of upadacitinib in participants with giant cell arteritis (SELECT-GCA). ClinicalTrials.gov. 2022. Updated March 21, 2023. Accessed March 21, 2023. https://clinicaltrials.gov/ct2/show/NCT03725202
- A study to evaluate the efficacy and safety of upadacitinib in participants with Takayasu arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. Updated November 28, 2022. Accessed March 6, 2023. https://clinicaltrials.gov/ct2/show/NCT04161898
* Endoscopic response is defined as a decrease in simple endoscopic score for Crohn’s disease (SES-CD) of >50% from baseline (or at least a 2-point reduction from baseline in patients with a baseline score of 4) of the induction.
† Clinical remission per SF/AP is defined as average daily very soft or liquid stool frequency ≤2.8 AND abdominal pain score ≤1.0 and neither greater than baseline.
‡ Corticosteroid-free clinical remission is defined as discontinuation of corticosteroid and achievement of clinical remission among subjects on corticosteroid at baseline in the induction studies and is defined as without corticosteroid use for 90 days and achievement of clinical remission in the maintenance study.
§ Mucosal healing is defined as SES-CD ulcerated surface subscore of 0 in patients with SES-CD ulcerated surface subscore ≥ 1 at baseline. Mucosal healing was a prespecified endpoint, not controlled for multiplicity.
SOURCE: AbbVie
Post Views: 83
