- Submissions are supported by the Phase 3 SELECT-GCA study demonstrating upadacitinib 15 mg with a 26-week steroid taper regimen achieved the primary endpoint of sustained remission from week 12 through week 521
- The safety profile of upadacitinib in patients with GCA was generally consistent with that in approved indications1
NORTH CHICAGO, IL, USA I July 12, 2024 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 upadacitinib (RINVOQ®; 15 mg, once daily) for the treatment of adult patients with giant cell arteritis (GCA).
GCA is an autoimmune disease of medium and large arteries and can cause headache, jaw pain, and changes in vision, including sudden and permanent loss of vision.3,4
“Currently, there are few approved treatment options for patients with GCA. Most patients are managed with glucocorticoids, and many are unable to discontinue them without the recurrence of GCA symptoms,” stated Roopal Thakkar, M.D., executive vice president, research and development, and chief scientific officer, AbbVie. “We recognize the importance of maintaining remission and limiting the use of glucocorticoids in GCA.”
The regulatory submissions to the FDA and EMA are supported by previously announced results from the SELECT-GCA Phase 3 study evaluating the safety and efficacy of upadacitinib in patients with GCA.
About SELECT-GCA
SELECT-GCA (M16-852) is a Phase 3, multicenter, randomized, double-blind placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib in 428 patients with GCA. The study consists of two periods. The first period evaluated the efficacy of upadacitinib in combination with a 26-week corticosteroid taper regimen compared to placebo in combination with a 52-week corticosteroid taper regimen. In addition, the first period assessed the safety and tolerability of upadacitinib in these patients. The second period is ongoing to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in the first period.1 For more information regarding this study, please visit ClinicalTrials.gov (Identifier NCT03725202).
About Giant Cell Arteritis
Giant cell arteritis (GCA), also known as temporal arteritis, is an autoimmune disease of medium and large arteries, characterized by granulomatous inflammation of the three-layered vessel wall, which affects temporal and other cranial arteries as well as the aorta and other large arteries.2,4 GCA can cause headache, jaw pain, and changes in or loss of vision, including sudden and permanent loss of vision. Caucasian women over the age of 50 – most commonly between the ages of 70 and 80 years – have the highest risk of developing giant cell arteritis. Although women are more likely than men to develop GCA, research suggests that men are more likely to have ocular manifestations with their disease.5
About Upadacitinib (RINVOQ®)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.6,7 Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.6 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, giant cell arteritis, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.8-12 The use of upadacitinib in giant cell arteritis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
RINVOQ® (upadacitinib) U.S. Uses and Important Safety Information
RINVOQ is a prescription medicine used to treat:
- Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.
- Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
- Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
- Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated.
- Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
- Adults with moderate to severe Crohn’s disease (CD) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
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 Rheumatology
For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Anchored by a longstanding commitment to discovering and delivering transformative therapies, we pursue cutting-edge science that improves our understanding of promising new pathways and targets, ultimately helping more people living with rheumatic diseases reach their treatment goals. For more information, visit AbbVie in rheumatology.
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 LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.
REFERENCES
- AbbVie. Data on file ABVRRTI78418.
- Ameer MA, Peterfy RJ, Khazaeni B. Giant cell arteritis. Updated August 8, 2023. https://www.ncbi.nlm.nih.gov/books/NBK459376/
- Weyand CM, Goronzy JJ. Immunology of Giant Cell Arteritis. Circ Res. 2023;132(2):238-250. doi:10.1161/CIRCRESAHA.122.322128
- Giant Cell Arteritis. Arthritis Foundation. Available at: https://www.arthritis.org/diseases/giant-cell-arteritis. Accessed April 11, 2024.
- RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2024.
- Pipeline – Our Science | AbbVie. 2023. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed April 17, 2024.
- A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants with Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed April 9, 2024
- A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants with Takaysu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT04161898. Accessed April 9, 2024.
- Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus (SELECT-SLE). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05843643. Accessed April 9, 2024.
- A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy (Step-Up HS). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05889182. Accessed April 9, 2024.
- A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo (Viti-Up). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06118411. Accessed April 9, 2024.
- A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (Up-AA). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06012240. Accessed April 9, 2024.
SOURCE: AbbVie
Post Views: 5,124
- Submissions are supported by the Phase 3 SELECT-GCA study demonstrating upadacitinib 15 mg with a 26-week steroid taper regimen achieved the primary endpoint of sustained remission from week 12 through week 521
- The safety profile of upadacitinib in patients with GCA was generally consistent with that in approved indications1
NORTH CHICAGO, IL, USA I July 12, 2024 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 upadacitinib (RINVOQ®; 15 mg, once daily) for the treatment of adult patients with giant cell arteritis (GCA).
GCA is an autoimmune disease of medium and large arteries and can cause headache, jaw pain, and changes in vision, including sudden and permanent loss of vision.3,4
“Currently, there are few approved treatment options for patients with GCA. Most patients are managed with glucocorticoids, and many are unable to discontinue them without the recurrence of GCA symptoms,” stated Roopal Thakkar, M.D., executive vice president, research and development, and chief scientific officer, AbbVie. “We recognize the importance of maintaining remission and limiting the use of glucocorticoids in GCA.”
The regulatory submissions to the FDA and EMA are supported by previously announced results from the SELECT-GCA Phase 3 study evaluating the safety and efficacy of upadacitinib in patients with GCA.
About SELECT-GCA
SELECT-GCA (M16-852) is a Phase 3, multicenter, randomized, double-blind placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib in 428 patients with GCA. The study consists of two periods. The first period evaluated the efficacy of upadacitinib in combination with a 26-week corticosteroid taper regimen compared to placebo in combination with a 52-week corticosteroid taper regimen. In addition, the first period assessed the safety and tolerability of upadacitinib in these patients. The second period is ongoing to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in the first period.1 For more information regarding this study, please visit ClinicalTrials.gov (Identifier NCT03725202).
About Giant Cell Arteritis
Giant cell arteritis (GCA), also known as temporal arteritis, is an autoimmune disease of medium and large arteries, characterized by granulomatous inflammation of the three-layered vessel wall, which affects temporal and other cranial arteries as well as the aorta and other large arteries.2,4 GCA can cause headache, jaw pain, and changes in or loss of vision, including sudden and permanent loss of vision. Caucasian women over the age of 50 – most commonly between the ages of 70 and 80 years – have the highest risk of developing giant cell arteritis. Although women are more likely than men to develop GCA, research suggests that men are more likely to have ocular manifestations with their disease.5
About Upadacitinib (RINVOQ®)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.6,7 Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.6 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, giant cell arteritis, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.8-12 The use of upadacitinib in giant cell arteritis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
RINVOQ® (upadacitinib) U.S. Uses and Important Safety Information
RINVOQ is a prescription medicine used to treat:
- Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.
- Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
- Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
- Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated.
- Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
- Adults with moderate to severe Crohn’s disease (CD) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
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 Rheumatology
For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Anchored by a longstanding commitment to discovering and delivering transformative therapies, we pursue cutting-edge science that improves our understanding of promising new pathways and targets, ultimately helping more people living with rheumatic diseases reach their treatment goals. For more information, visit AbbVie in rheumatology.
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 LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.
REFERENCES
- AbbVie. Data on file ABVRRTI78418.
- Ameer MA, Peterfy RJ, Khazaeni B. Giant cell arteritis. Updated August 8, 2023. https://www.ncbi.nlm.nih.gov/books/NBK459376/
- Weyand CM, Goronzy JJ. Immunology of Giant Cell Arteritis. Circ Res. 2023;132(2):238-250. doi:10.1161/CIRCRESAHA.122.322128
- Giant Cell Arteritis. Arthritis Foundation. Available at: https://www.arthritis.org/diseases/giant-cell-arteritis. Accessed April 11, 2024.
- RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2024.
- Pipeline – Our Science | AbbVie. 2023. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed April 17, 2024.
- A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants with Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed April 9, 2024
- A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants with Takaysu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT04161898. Accessed April 9, 2024.
- Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus (SELECT-SLE). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05843643. Accessed April 9, 2024.
- A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy (Step-Up HS). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05889182. Accessed April 9, 2024.
- A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo (Viti-Up). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06118411. Accessed April 9, 2024.
- A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (Up-AA). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06012240. Accessed April 9, 2024.
SOURCE: AbbVie
Post Views: 5,124
