− Results from the Phase 3 SELECT-GCA study showed 46 percent of patients with giant cell arteritis (GCA) who were treated with upadacitinib (RINVOQ®; 15 mg) with a 26-week steroid taper regimen achieved sustained remission from week 12 through week 52 compared to 29 percent of patients receiving placebo with a 52-week steroid taper regimen1
− The safety profile in GCA was generally consistent with that in approved indications, and no new safety signals were identified1
− The clinical program reflects AbbVie’s history of developing new treatment options for patients with immune-mediated diseases, where there remains significant unmet medical need
NORTH CHICAGO, IL, USA I April 18, 2024 I AbbVie (NYSE: ABBV) today announced positive top-line results from SELECT-GCA, a Phase 3, multicenter, randomized, double-blind, placebo-controlled study, showing upadacitinib (RINVOQ®; 15 mg, once daily) in combination with a 26-week steroid taper regimen achieved its primary endpoint of sustained remissiona from week 12 through week 52 in adults with giant cell arteritis (GCA). In this study, 46 percent of patients receiving upadacitinib 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission compared to 29 percent of patients receiving placebo in combination with a 52-week steroid taper regimen (p=0.0019).1
“Many people living with GCA continue to suffer from the potentially debilitating symptoms of this disease, with limited treatment options available to them,” said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. “These results demonstrate our relentless commitment to improving the lives of people living with immune-mediated diseases by developing new treatments where significant medical needs still exist.”
GCA is an autoimmune disease that causes inflammation of the temporal and other cranial arteries, the aorta, and other large and medium arteries. GCA generally impacts elderly patients older than 50 years, most commonly between the ages of 70 and 80 years. Women have the highest risk of developing this disease, which can cause headache, jaw pain and changes in or loss of vision, including sudden and permanent loss of vision.2
Key secondary endpoints were also met, including a higher percentage of patients receiving upadacitinib 15 mg in combination with a 26-week steroid taper regimen achieved sustained complete remissionb from week 12 through week 52 compared to patients receiving placebo in combination with a 52-week steroid taper regimen (37 percent versus 16 percent; p<0.0001).1 A lower percentage of patients experienced at least one disease flare through week 52 in the upadacitinib 15 mg group versus the placebo group (34 percent versus 56 percent; p=0.0014).1 The study results also showed that upadacitinib 7.5 mg did not meet the primary or any of the secondary endpoints.1
“I am encouraged by these results, which add to the body of evidence supporting the efficacy and safety profile of upadacitinib for the treatment of rheumatic diseases,” said Daniel Blockmans, M.D., Ph.D., Department of General Internal Medicine, University Hospitals Gasthuisberg, Belgium, professor of medicine, KU Leuven, Belgium, and lead investigator of the SELECT-GCA trial. “Based on these results, upadacitinib has the potential to be the first oral treatment option for patients with GCA, a disease with inflammation of the large arteries that primarily impacts older people and has only one approved treatment to date3 commonly used with steroids.”
During the 52-week, placebo-controlled period, the safety profile of upadacitinib 15 mg was generally consistent with that observed in approved indications.1 Upadacitinib 15 mg was generally well tolerated, with no new safety signals identified in this GCA population.1 Discontinuations due to adverse events occurred in 15 percent of patients in the upadacitinib 15 mg group and 21 percent of patients in the placebo group.1 In this study, the proportion of patients who experienced a serious adverse event was similar (23 percent in the upadacitinib 15 mg group and 21 percent in the placebo group).1 Serious infections occurred in 6 percent of the upadacitinib 15 mg group and 11 percent of the placebo group.1 Overall, the proportions of patients with incidence of malignancy excluding non-melanoma skin cancer and adjudicated venous thromboembolic events (VTEs) were balanced across both the upadacitinib 15 mg (2 percent and 3 percent, respectively) and placebo (2 percent and 4 percent, respectively) treatment groups.1 There were no adjudicated major adverse cardiac events (MACE) in the upadacitinib 15 mg group compared to two events in the placebo group.1 Four treatment-emergent deaths were reported, two in the placebo group and two in the upadacitinib 15 mg group.1 Of the two treatment-emergent deaths in the upadacitinib 15 mg group, one was attributed to COVID-19, and the other was adjudicated as an unexplained cause.1
Full results across all treatment groups from the SELECT-GCA study will be presented at a future medical meeting. Use of upadacitinib in GCA is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
a Sustained remission is defined as having an absence of GCA signs and symptoms from week 12 through week 52 and adherence to the protocol-defined steroid taper over the course of the study term.
b Sustained complete remission is defined as having an absence of GCA signs and symptoms from week 12 through week 52, adherence to the protocol-defined steroid taper, and normalization of both erythrocyte sedimentation rate (ESR) and high sensitivity C-reactive protein (hsCRP) from week 12 through week 52.
About SELECT-GCA
SELECT-GCA (M16-852) was 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, which is reported in this release, 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 study assessed the safety and tolerability of upadacitinib in these patients. The second period will 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.2 It is the most common vasculitis affecting adults in western countries.2 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.8-13
RINVOQ (upadacitinib) U.S. Uses and Important Safety Information6
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.
It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn’s disease.
- Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended.
RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis.
It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.
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.
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.
- 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/
- RoActemra 20 mg/mL concentrate for solution for infusion. SmPC Mar 2023
- 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.; 2023.
- 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: 1,018
− Results from the Phase 3 SELECT-GCA study showed 46 percent of patients with giant cell arteritis (GCA) who were treated with upadacitinib (RINVOQ®; 15 mg) with a 26-week steroid taper regimen achieved sustained remission from week 12 through week 52 compared to 29 percent of patients receiving placebo with a 52-week steroid taper regimen1
− The safety profile in GCA was generally consistent with that in approved indications, and no new safety signals were identified1
− The clinical program reflects AbbVie’s history of developing new treatment options for patients with immune-mediated diseases, where there remains significant unmet medical need
NORTH CHICAGO, IL, USA I April 18, 2024 I AbbVie (NYSE: ABBV) today announced positive top-line results from SELECT-GCA, a Phase 3, multicenter, randomized, double-blind, placebo-controlled study, showing upadacitinib (RINVOQ®; 15 mg, once daily) in combination with a 26-week steroid taper regimen achieved its primary endpoint of sustained remissiona from week 12 through week 52 in adults with giant cell arteritis (GCA). In this study, 46 percent of patients receiving upadacitinib 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission compared to 29 percent of patients receiving placebo in combination with a 52-week steroid taper regimen (p=0.0019).1
“Many people living with GCA continue to suffer from the potentially debilitating symptoms of this disease, with limited treatment options available to them,” said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. “These results demonstrate our relentless commitment to improving the lives of people living with immune-mediated diseases by developing new treatments where significant medical needs still exist.”
GCA is an autoimmune disease that causes inflammation of the temporal and other cranial arteries, the aorta, and other large and medium arteries. GCA generally impacts elderly patients older than 50 years, most commonly between the ages of 70 and 80 years. Women have the highest risk of developing this disease, which can cause headache, jaw pain and changes in or loss of vision, including sudden and permanent loss of vision.2
Key secondary endpoints were also met, including a higher percentage of patients receiving upadacitinib 15 mg in combination with a 26-week steroid taper regimen achieved sustained complete remissionb from week 12 through week 52 compared to patients receiving placebo in combination with a 52-week steroid taper regimen (37 percent versus 16 percent; p<0.0001).1 A lower percentage of patients experienced at least one disease flare through week 52 in the upadacitinib 15 mg group versus the placebo group (34 percent versus 56 percent; p=0.0014).1 The study results also showed that upadacitinib 7.5 mg did not meet the primary or any of the secondary endpoints.1
“I am encouraged by these results, which add to the body of evidence supporting the efficacy and safety profile of upadacitinib for the treatment of rheumatic diseases,” said Daniel Blockmans, M.D., Ph.D., Department of General Internal Medicine, University Hospitals Gasthuisberg, Belgium, professor of medicine, KU Leuven, Belgium, and lead investigator of the SELECT-GCA trial. “Based on these results, upadacitinib has the potential to be the first oral treatment option for patients with GCA, a disease with inflammation of the large arteries that primarily impacts older people and has only one approved treatment to date3 commonly used with steroids.”
During the 52-week, placebo-controlled period, the safety profile of upadacitinib 15 mg was generally consistent with that observed in approved indications.1 Upadacitinib 15 mg was generally well tolerated, with no new safety signals identified in this GCA population.1 Discontinuations due to adverse events occurred in 15 percent of patients in the upadacitinib 15 mg group and 21 percent of patients in the placebo group.1 In this study, the proportion of patients who experienced a serious adverse event was similar (23 percent in the upadacitinib 15 mg group and 21 percent in the placebo group).1 Serious infections occurred in 6 percent of the upadacitinib 15 mg group and 11 percent of the placebo group.1 Overall, the proportions of patients with incidence of malignancy excluding non-melanoma skin cancer and adjudicated venous thromboembolic events (VTEs) were balanced across both the upadacitinib 15 mg (2 percent and 3 percent, respectively) and placebo (2 percent and 4 percent, respectively) treatment groups.1 There were no adjudicated major adverse cardiac events (MACE) in the upadacitinib 15 mg group compared to two events in the placebo group.1 Four treatment-emergent deaths were reported, two in the placebo group and two in the upadacitinib 15 mg group.1 Of the two treatment-emergent deaths in the upadacitinib 15 mg group, one was attributed to COVID-19, and the other was adjudicated as an unexplained cause.1
Full results across all treatment groups from the SELECT-GCA study will be presented at a future medical meeting. Use of upadacitinib in GCA is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
a Sustained remission is defined as having an absence of GCA signs and symptoms from week 12 through week 52 and adherence to the protocol-defined steroid taper over the course of the study term.
b Sustained complete remission is defined as having an absence of GCA signs and symptoms from week 12 through week 52, adherence to the protocol-defined steroid taper, and normalization of both erythrocyte sedimentation rate (ESR) and high sensitivity C-reactive protein (hsCRP) from week 12 through week 52.
About SELECT-GCA
SELECT-GCA (M16-852) was 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, which is reported in this release, 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 study assessed the safety and tolerability of upadacitinib in these patients. The second period will 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.2 It is the most common vasculitis affecting adults in western countries.2 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.8-13
RINVOQ (upadacitinib) U.S. Uses and Important Safety Information6
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.
It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn’s disease.
- Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended.
RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis.
It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.
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.
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.
- 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/
- RoActemra 20 mg/mL concentrate for solution for infusion. SmPC Mar 2023
- 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.; 2023.
- 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: 1,018
