– In U-EXCEED, a significantly higher proportion of patients with moderate to severe Crohn’s disease treated with upadacitinib (45 mg once daily for induction) achieved both primary endpoints of clinical remission[a,b] and endoscopic response[c] compared to placebo at week 12[1]
– The study showed that a significantly higher proportion of upadacitinib-treated patients achieved steroid-free clinical remission[d] at week 12 compared to placebo[1]
– The safety results in this study were consistent with the known profile of upadacitinib, with no new safety risks observed[1-6]
– Upadacitinib, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is being studied as an oral therapy for moderate to severe Crohn’s disease and several other immune-mediated inflammatory diseases[1,6-14]
NORTH CHICAGO, IL, USA I December 6, 2021 I AbbVie (NYSE: ABBV) today announced positive top-line results from U-EXCEED, a Phase 3 induction study, showing upadacitinib (45 mg once daily) achieved both primary endpoints of clinical remissiona,b and endoscopic responsec at week 12.1 The U-EXCEED study enrolled patients with moderate to severe Crohn’s disease who had an inadequate response or were intolerant to biologic therapy, with over 60 percent having previously failed two or more biologics.1 U-EXCEED is the first of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe Crohn’s disease.1
“The data from this first Phase 3 induction study in Crohn’s disease suggest upadacitinib may help address the needs of patients suffering from this disease, as demonstrated in stringent endpoints such as endoscopic response,” said Michael Severino, M.D., vice chairman and president, AbbVie. “We continue to leverage our expertise in IBD by driving research and development that help shape the IBD landscape and elevate standards of care for patients.”
In U-EXCEED, clinical remission was measured by the Crohn’s Disease Activity Index (CDAI) and by the patient-reported symptoms of stool frequency/abdominal pain (SF/AP).1 A significantly greater proportion of patients treated with a 12-week induction regimen of upadacitinib 45 mg daily achieved clinical remission per CDAI at week 12 compared to placebo (39 percent, versus 21 percent; p<0.0001).1 Similar results were seen with clinical remission per SF/AP (40 percent in upadacitinib-treated patients versus 14 percent in placebo-treated patients; p<0.0001).1 In this study, all patients were also evaluated for improvement in the intestinal mucosa by endoscopy.1 At week 12, a significantly greater proportion of patients treated with upadacitinib 45 mg achieved endoscopic response compared to the placebo group (35 percent versus 4 percent; p<0.0001).1
Among patients taking corticosteroids at baseline, a significantly higher proportion of patients receiving upadacitinib 45 mg achieved steroid-free clinical remissiond per CDAI and per SF/AP compared to placebo at week 12.1 A significantly higher proportion of patients receiving upadacitinib compared to placebo also achieved early symptom improvement measured by CR-100 (defined as reduction of CDAI ≥100 points from baseline) at week 2 as well as clinical remission at week 4.1
“I am thrilled to see the results of this first Phase 3 induction study of upadacitinib, particularly in this difficult-to-treat refractory patient population,” said Jean-Frederic Colombel, M.D., professor of medicine and director of Inflammatory Bowel Disease Center, Icahn School of Medicine, Mount Sinai, and U-EXCEED study investigator. “These results demonstrate upadacitinib’s potential to achieve endoscopic response and clinical remission, including steroid-free clinical remission, at 12 weeks in patients living with Crohn’s disease.”
| Efficacy Results at Week 121 |
| |
Placebo
(n=171)
|
Upadacitinib 45 mg
(n = 324)
|
| Clinical Remission (per CDAI)a |
21% |
39%* |
| Clinical Remission (per SF/AP)b |
14% |
40%* |
| Endoscopic Responsec |
4% |
35%* |
| * Co-primary endpoints were clinical remission (per CDAI for the U.S. FDA and per SF/AP for the EU EMA) and endoscopic response at week 12. All primary endpoints achieved statistical significance with p-values of <0.0001 versus placebo. |
| a Clinical remission (per CDAI) is defined as CDAI <150. |
| b Clinical remission per SF (stool frequency)/AP (abdominal pain) (also referred to as PRO-2) is defined as average daily very soft or liquid stool frequency ≤2.8 AND average daily abdominal pain score ≤1.0, and both not greater than baseline. |
| c Endoscopic response is defined as a decrease in simple endoscopic score for Crohn’s disease (SES-CD) of >50 percent from baseline (or at least a 2-point reduction from baseline for subjects with a baseline SES-CD of 4), as scored by central reviewer. |
During the 12-week, double-blind, placebo-controlled period, the safety profile of upadacitinib 45 mg was consistent with the safety profile observed in previous studies across indications, with no new safety risks observed.1 The most common adverse event was nasopharyngitis for upadacitinib and exacerbation of Crohn’s disease for placebo.1 Serious adverse events occurred in 9.3 percent of patients in the upadacitinib 45 mg group compared to 9.9 percent of patients in the placebo group.1 Rates of serious infections were 2.8 percent in those treated with upadacitinib 45 mg and 1.8 percent in patients who received placebo.1 All events of herpes zoster (1.5 percent of patients) were nonserious and reported in the upadacitinib group only.1 There was one case of adjudicated gastrointestinal perforation in the upadacitinib group.1
An additional 207 patients at week 12 received an upadacitinib 45 mg daily induction regimen (including non-responders to placebo or from an open label arm).1 Among these patients, there were two additional cases of adjudicated gastrointestinal perforation reported.1 Overall, the safety results in these patients were consistent with what was observed in the upadacitinib 45 mg group during the placebo-controlled period.1
In the study, no treatment-emergent cases of adjudicated cardiovascular event, malignancy, thromboembolic event or death were reported across treatment groups.1
Full results from the U-EXCEED study will be presented at upcoming medical conferences and published in a peer-reviewed medical journal. Use of upadacitinib in Crohn’s disease is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
| dSteroid-free clinical remission is defined as clinical remission (per CDAI <150, or per SF/AP with average daily SF ≤2.8 and not worse than baseline and average daily AP score ≤1 and not worse than baseline) and discontinuation of corticosteroid use among patients taking corticosteroids at baseline. |
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 and abdominal pain.15-17 It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients.16,17 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.18
About U-EXCEED1,14
The U-EXCEED study is one of two Phase 3, multicenter, randomized, double-blind, placebo-controlled induction studies designed to evaluate the efficacy and safety of upadacitinib 45 mg induction treatment in adults with moderate to severe Crohn’s disease. U-EXCEED enrolled patients who had inadequately responded to or are intolerant of biologic therapy. The second induction study evaluated patients who have had an inadequate response or intolerance to one or more conventional and/or biologic therapies.19
The U-EXCEED study includes three study parts. Part 1 is the 12-week placebo-controlled induction portion. Part 2 is the open label arm of U-EXCEED evaluating an additional group of patients who received upadacitinib 45 mg for 12 weeks. In Part 3, patients who did not achieve clinical response in Part 1 or Part 2 received an extended treatment of upadacitinib 45 mg or 30 mg for 12 weeks.
The study included slightly different sets of primary and secondary endpoints for the U.S. Food and Drug Administration (FDA) and the EU European Medicines Agency (EMA). The primary endpoints were achievement of clinical remission (per CDAI for the U.S. FDA, and per SF/AP for the EU EMA, which was measured by average daily stool frequency and abdominal pain score) and endoscopic response (per SES-CD) at week 12. More information can be found on www.clinicaltrials.gov (NCT03345836).
About the Upadacitinib Phase 3 Crohn’s Disease Program14,19,20
The global upadacitinib Phase 3 program evaluates more than 1,000 patients with moderate to severe Crohn’s disease across two induction studies and a maintenance study. These studies include assessments of efficacy, safety and tolerability of upadacitinib. More information on these trials can be found at www.clinicaltrials.gov (NCT03345836, NCT03345849, NCT03345823).
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.6-14,21 Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.21 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known. RINVOQ 15 mg is approved by the U.S. Food and Drug Administration (FDA) for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. RINVOQ is also 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. 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.7-14 The use of upadacitinib in Crohn’s disease is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
Please click here for the Full Prescribing Information and Medication Guide.
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 its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.
References:
- AbbVie. Data on File: ABVRRTI73267.
- Cohen S., et al. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2020 Oct 28;80(3):304-11.
- Mease, P.J., et al. Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study. Rheumatol Ther. 2021 Apr 28. doi: 10.1007/s40744-021-00305-z. Online ahead of print.
- Guttman-Yassky E., 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, randomized controlled phase 3 studies. Lancet. doi:10.1016/s0140-6736(21)00588-2.
- Van der Heijde, D., 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 Dec 7;394(10214):2108-2117. doi: 10.1016/S0140-6736(19)32534-6. Epub 2019 Nov 12.
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; September 2021. Available at: https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf.
- Pipeline – Our Science | AbbVie. AbbVie. 2021. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on November 9, 2021.
- A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed on November 9, 2021.
- A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on November 9, 2021.
- A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed on November 9, 2021.
- A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis (U-ACCOMPLISH). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03653026. Accessed on November 9, 2021.
- A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on November 9, 2021.
- A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04161898. Accessed on November 9, 2021.
- A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03345836. Accessed on November 9, 2021.
- Kaplan, G. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol. 2015 Dec;12(12):720-7. doi: 10.1038/nrgastro.2015.150.
- The Facts about Inflammatory Bowel Diseases. Crohn’s & Colitis Foundation of America. 2014. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf. Accessed on November 9, 2021.
- Crohn’s disease. Symptoms and Causes. Mayo Clinic. 2021. Available at: https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304. Accessed on November 9, 2021.
- The Economic Costs of Crohn’s Disease and Ulcerative Colitis. Access Economics Pty Limited. 2007. Available at: https://www.crohnsandcolitis.com.au/site/wp-content/uploads/Deloitte-Access-Economics-Report.pdf. Accessed on November 9, 2021.
- A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03345849. Accessed on November 9, 2021.
- A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn’s Disease Who Completed the Studies M14-431 or M14-433. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03345823. Accessed on November 9, 2021.
- RINVOQ® (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
SOURCE: AbbVie
Post Views: 72
– In U-EXCEED, a significantly higher proportion of patients with moderate to severe Crohn’s disease treated with upadacitinib (45 mg once daily for induction) achieved both primary endpoints of clinical remission[a,b] and endoscopic response[c] compared to placebo at week 12[1]
– The study showed that a significantly higher proportion of upadacitinib-treated patients achieved steroid-free clinical remission[d] at week 12 compared to placebo[1]
– The safety results in this study were consistent with the known profile of upadacitinib, with no new safety risks observed[1-6]
– Upadacitinib, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is being studied as an oral therapy for moderate to severe Crohn’s disease and several other immune-mediated inflammatory diseases[1,6-14]
NORTH CHICAGO, IL, USA I December 6, 2021 I AbbVie (NYSE: ABBV) today announced positive top-line results from U-EXCEED, a Phase 3 induction study, showing upadacitinib (45 mg once daily) achieved both primary endpoints of clinical remissiona,b and endoscopic responsec at week 12.1 The U-EXCEED study enrolled patients with moderate to severe Crohn’s disease who had an inadequate response or were intolerant to biologic therapy, with over 60 percent having previously failed two or more biologics.1 U-EXCEED is the first of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe Crohn’s disease.1
“The data from this first Phase 3 induction study in Crohn’s disease suggest upadacitinib may help address the needs of patients suffering from this disease, as demonstrated in stringent endpoints such as endoscopic response,” said Michael Severino, M.D., vice chairman and president, AbbVie. “We continue to leverage our expertise in IBD by driving research and development that help shape the IBD landscape and elevate standards of care for patients.”
In U-EXCEED, clinical remission was measured by the Crohn’s Disease Activity Index (CDAI) and by the patient-reported symptoms of stool frequency/abdominal pain (SF/AP).1 A significantly greater proportion of patients treated with a 12-week induction regimen of upadacitinib 45 mg daily achieved clinical remission per CDAI at week 12 compared to placebo (39 percent, versus 21 percent; p<0.0001).1 Similar results were seen with clinical remission per SF/AP (40 percent in upadacitinib-treated patients versus 14 percent in placebo-treated patients; p<0.0001).1 In this study, all patients were also evaluated for improvement in the intestinal mucosa by endoscopy.1 At week 12, a significantly greater proportion of patients treated with upadacitinib 45 mg achieved endoscopic response compared to the placebo group (35 percent versus 4 percent; p<0.0001).1
Among patients taking corticosteroids at baseline, a significantly higher proportion of patients receiving upadacitinib 45 mg achieved steroid-free clinical remissiond per CDAI and per SF/AP compared to placebo at week 12.1 A significantly higher proportion of patients receiving upadacitinib compared to placebo also achieved early symptom improvement measured by CR-100 (defined as reduction of CDAI ≥100 points from baseline) at week 2 as well as clinical remission at week 4.1
“I am thrilled to see the results of this first Phase 3 induction study of upadacitinib, particularly in this difficult-to-treat refractory patient population,” said Jean-Frederic Colombel, M.D., professor of medicine and director of Inflammatory Bowel Disease Center, Icahn School of Medicine, Mount Sinai, and U-EXCEED study investigator. “These results demonstrate upadacitinib’s potential to achieve endoscopic response and clinical remission, including steroid-free clinical remission, at 12 weeks in patients living with Crohn’s disease.”
| Efficacy Results at Week 121 |
| |
Placebo
(n=171)
|
Upadacitinib 45 mg
(n = 324)
|
| Clinical Remission (per CDAI)a |
21% |
39%* |
| Clinical Remission (per SF/AP)b |
14% |
40%* |
| Endoscopic Responsec |
4% |
35%* |
| * Co-primary endpoints were clinical remission (per CDAI for the U.S. FDA and per SF/AP for the EU EMA) and endoscopic response at week 12. All primary endpoints achieved statistical significance with p-values of <0.0001 versus placebo. |
| a Clinical remission (per CDAI) is defined as CDAI <150. |
| b Clinical remission per SF (stool frequency)/AP (abdominal pain) (also referred to as PRO-2) is defined as average daily very soft or liquid stool frequency ≤2.8 AND average daily abdominal pain score ≤1.0, and both not greater than baseline. |
| c Endoscopic response is defined as a decrease in simple endoscopic score for Crohn’s disease (SES-CD) of >50 percent from baseline (or at least a 2-point reduction from baseline for subjects with a baseline SES-CD of 4), as scored by central reviewer. |
During the 12-week, double-blind, placebo-controlled period, the safety profile of upadacitinib 45 mg was consistent with the safety profile observed in previous studies across indications, with no new safety risks observed.1 The most common adverse event was nasopharyngitis for upadacitinib and exacerbation of Crohn’s disease for placebo.1 Serious adverse events occurred in 9.3 percent of patients in the upadacitinib 45 mg group compared to 9.9 percent of patients in the placebo group.1 Rates of serious infections were 2.8 percent in those treated with upadacitinib 45 mg and 1.8 percent in patients who received placebo.1 All events of herpes zoster (1.5 percent of patients) were nonserious and reported in the upadacitinib group only.1 There was one case of adjudicated gastrointestinal perforation in the upadacitinib group.1
An additional 207 patients at week 12 received an upadacitinib 45 mg daily induction regimen (including non-responders to placebo or from an open label arm).1 Among these patients, there were two additional cases of adjudicated gastrointestinal perforation reported.1 Overall, the safety results in these patients were consistent with what was observed in the upadacitinib 45 mg group during the placebo-controlled period.1
In the study, no treatment-emergent cases of adjudicated cardiovascular event, malignancy, thromboembolic event or death were reported across treatment groups.1
Full results from the U-EXCEED study will be presented at upcoming medical conferences and published in a peer-reviewed medical journal. Use of upadacitinib in Crohn’s disease is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
| dSteroid-free clinical remission is defined as clinical remission (per CDAI <150, or per SF/AP with average daily SF ≤2.8 and not worse than baseline and average daily AP score ≤1 and not worse than baseline) and discontinuation of corticosteroid use among patients taking corticosteroids at baseline. |
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 and abdominal pain.15-17 It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients.16,17 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.18
About U-EXCEED1,14
The U-EXCEED study is one of two Phase 3, multicenter, randomized, double-blind, placebo-controlled induction studies designed to evaluate the efficacy and safety of upadacitinib 45 mg induction treatment in adults with moderate to severe Crohn’s disease. U-EXCEED enrolled patients who had inadequately responded to or are intolerant of biologic therapy. The second induction study evaluated patients who have had an inadequate response or intolerance to one or more conventional and/or biologic therapies.19
The U-EXCEED study includes three study parts. Part 1 is the 12-week placebo-controlled induction portion. Part 2 is the open label arm of U-EXCEED evaluating an additional group of patients who received upadacitinib 45 mg for 12 weeks. In Part 3, patients who did not achieve clinical response in Part 1 or Part 2 received an extended treatment of upadacitinib 45 mg or 30 mg for 12 weeks.
The study included slightly different sets of primary and secondary endpoints for the U.S. Food and Drug Administration (FDA) and the EU European Medicines Agency (EMA). The primary endpoints were achievement of clinical remission (per CDAI for the U.S. FDA, and per SF/AP for the EU EMA, which was measured by average daily stool frequency and abdominal pain score) and endoscopic response (per SES-CD) at week 12. More information can be found on www.clinicaltrials.gov (NCT03345836).
About the Upadacitinib Phase 3 Crohn’s Disease Program14,19,20
The global upadacitinib Phase 3 program evaluates more than 1,000 patients with moderate to severe Crohn’s disease across two induction studies and a maintenance study. These studies include assessments of efficacy, safety and tolerability of upadacitinib. More information on these trials can be found at www.clinicaltrials.gov (NCT03345836, NCT03345849, NCT03345823).
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.6-14,21 Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.21 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known. RINVOQ 15 mg is approved by the U.S. Food and Drug Administration (FDA) for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. RINVOQ is also 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. 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.7-14 The use of upadacitinib in Crohn’s disease is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
Please click here for the Full Prescribing Information and Medication Guide.
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 its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.
References:
- AbbVie. Data on File: ABVRRTI73267.
- Cohen S., et al. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2020 Oct 28;80(3):304-11.
- Mease, P.J., et al. Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study. Rheumatol Ther. 2021 Apr 28. doi: 10.1007/s40744-021-00305-z. Online ahead of print.
- Guttman-Yassky E., 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, randomized controlled phase 3 studies. Lancet. doi:10.1016/s0140-6736(21)00588-2.
- Van der Heijde, D., 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 Dec 7;394(10214):2108-2117. doi: 10.1016/S0140-6736(19)32534-6. Epub 2019 Nov 12.
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; September 2021. Available at: https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf.
- Pipeline – Our Science | AbbVie. AbbVie. 2021. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on November 9, 2021.
- A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed on November 9, 2021.
- A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on November 9, 2021.
- A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed on November 9, 2021.
- A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis (U-ACCOMPLISH). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03653026. Accessed on November 9, 2021.
- A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on November 9, 2021.
- A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04161898. Accessed on November 9, 2021.
- A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03345836. Accessed on November 9, 2021.
- Kaplan, G. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol. 2015 Dec;12(12):720-7. doi: 10.1038/nrgastro.2015.150.
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SOURCE: AbbVie
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