ANVISA Approves RINVOQ (upadacitinib), JAK1 inhibitor, for the Treatment of Rheumatoid Arthritis (RA)
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Press Release[/caption]
RINVOQ???? achieved primary and secondary goals in different profiles of patients with moderate to severe active rheumatoid arthritis?3-7?.?29% of patients being treated with RINVOQ???+ MTX, assessed by?DAS28 - PCR,?achieved remission at week 12 in the SELECT COMPARE?3?study?. Rheumatoid Arthritis
It is estimated that rheumatoid arthritis affects about 1% of the world population, starting between 30-40 years of age (*).?It is a complex systemic autoimmune disease, which occurs when the immune system mistakenly attacks the joints, creating inflammation, thickening and edema of the tissue within the joints, damaging the bones and connective tissues?9-10?.??Pain, tiredness and morning stiffness are some of the signs and symptoms of RA that can have an impact on daily life?11?.?If not treated properly, RA can lead to permanent damage to bones and cartilage. RINVOQ????
RINVOQ???is an oral JAK1 inhibitor and is indicated in Brazil for the treatment of adult patients with moderate to severe active rheumatoid arthritis, who have not responded adequately, or who have been intolerant, to one or more antirheumatic drugs modifying the disease course (DMARD)?1?.?To date, it has also been approved by the FDA, the United States regulatory agency, and the European Commission?12?. About AbbVie
AbbVie is a global biopharmaceutical company based on research and development, which is committed to developing innovative and advanced therapies for some of the most complex and critical health conditions in the world.?The company's mission is to use its knowledge, dedicated team and focus on innovation to remarkably improve treatments in four main therapeutic areas: immunology, oncology, virology and neuroscience.?In more than 75 countries, AbbVie employees work daily to develop healthcare solutions for people around the world.?For more information about AbbVie, visit??www.abbvie.com??follow??@abbvie??on Twitter,??Facebook?,??LinkedIn??or??Instagram. In Brazil, AbbVie started operating in early 2014. Its local business units include immunology, neonatology, virology and oncology and, among its different areas of activity, it conducts more than 40 studies and clinical projects, involving more than 200 teams and Brazilian research centers?12?.?For more information, visit??www.abbvie.com.br References
(*)?https://www.reumatologia.org.br/doencas-reumaticas/artrite-reumatoide/??accessed on 12/4/2019???
(**) At?http://www.in.gov.br/web/ dou / - / resolucao-re-n-315-de-30-de-janeiro-de-2020-241100867??
1?Package insert for the product.?
2??Clark JD, Flanagan ME, Telliez JB.?Discovery and Development of Janus Kinase (JAK) Inhibitors for?Inflammatory Diseases.?J Med Chem 2014; 57: 5023?38?
3??Smolen JS?,??Pangan AL?,??Emery P?,??Rigby W?,??Tanaka Y?,??Vargas JI?,??Zhang Y?,??Damjanov N?,??Friedman A,??Othman AA?,??Camp HS?,??Cohen S?.??Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomized, placebo-controlled, double-blind phase 3 study.?Lancet 2019;?(8): 2303-2311.?doi: 10.1016 / S0140-6736 (19) 30419-2?
4?Fleischmann RM, Genovese MC, Enejosa JV, et al.?Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternate therapy in patients with insufficient response,?2019?.?Ann Rheum, doi: 10.1136 / annrheumdis?2019?215764?
5Burmester GR, et al.?Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomized, double-blind, placebo-controlled phase 3 trial.?Lancet.?2018; 391 (10139): 2503-2512.?doi: 10.1016 / S0140-6736 (18) 31115-2.?Epub 2018 Jun 18.?
6?Genovese MC, Fleischmann R, Combe B et al.?Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomized controlled phase 3 trial.Lancet 2018;?391 (10139): 2513-2524.?doi: 10.1016 / S0140-6736 (18) 31116-4?
7van Vollenhoven R, Takeuchi T, Pangan AL et al.?A Phase 3, Randomized, Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Na?ve Patients with Active Rheumatoid Arthritis [abstract].?Rheumatol arthritis.?2018;?70 (suppl 10).?https://acrabstracts.org/abstract/a-phase-3-randomized-controlled-trial-comparing-upadacitinib-monotherapy-to-mtx-monotherapy-in-mtxnaive-patients-with-active-rheumatoid-arthritis/?.?
8?Rivellese?F, Lobasso A, Barbieri L et al.?Novel Therapeutic Approaches in Rheumatoid Arthritis: Role of Janus Kinases Inhibitors.?Current Medicinal Chemistry 2018;?(25): 1-19?
9??Arthritis Foundation.What is Rheumatoid Arthritis.?Available at: https://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid- arthritis.php.?Accessed?7/9/2019?
10??Hunter T, et al.?Rheumatology International.?Prevalence of rheumatoid arthritis in the United States adult population in healthcare claims databases, 2004?2014.?April / 2017?
11?American College of Rheumatology.?Rheumatoid Arthritis.?Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Rheumatoid- Arthritis.?Accessed on?6/7/2019?
12?AbbVie??data, available at?https://news.abbvie.com/??and?https://www.abbvie.com.br/ AbbVie Brasil SOURCE
SOURCE AbbVie Brasil
Press Release[/caption]
- INVOQ???(upadacitinib?1?is an oral agent, inhibitor of JAK 1?2?(janus kinase1, intracellular enzyme responsible for the signaling of cytokines involved in RA pathogenesis) in a single daily dose.
- The approval of RINVOQ???was based on data from five studies from one of the largest Phase 3 clinical development programs in RA, called SELECT?1.3-7?, which evaluated approximately 4,400 patients, including in Brazil
- RINVOQ? achieved primary and secondary goals in different profiles of patients with moderate to severe active rheumatoid arthritis?3-7?.
- 29% of patients being treated with RINVOQ???? + MTX (methotrexate) achieved??remission, assessed by the DAS28 - PCR index, at week 12 in the SELECT COMPARE?4?study?.
- It is estimated that about 1% of the world population (*) has rheumatoid arthritis, a chronic inflammatory disease (with no cure).
RINVOQ???? achieved primary and secondary goals in different profiles of patients with moderate to severe active rheumatoid arthritis?3-7?.?29% of patients being treated with RINVOQ???+ MTX, assessed by?DAS28 - PCR,?achieved remission at week 12 in the SELECT COMPARE?3?study?. Rheumatoid Arthritis
It is estimated that rheumatoid arthritis affects about 1% of the world population, starting between 30-40 years of age (*).?It is a complex systemic autoimmune disease, which occurs when the immune system mistakenly attacks the joints, creating inflammation, thickening and edema of the tissue within the joints, damaging the bones and connective tissues?9-10?.??Pain, tiredness and morning stiffness are some of the signs and symptoms of RA that can have an impact on daily life?11?.?If not treated properly, RA can lead to permanent damage to bones and cartilage. RINVOQ????
RINVOQ???is an oral JAK1 inhibitor and is indicated in Brazil for the treatment of adult patients with moderate to severe active rheumatoid arthritis, who have not responded adequately, or who have been intolerant, to one or more antirheumatic drugs modifying the disease course (DMARD)?1?.?To date, it has also been approved by the FDA, the United States regulatory agency, and the European Commission?12?. About AbbVie
AbbVie is a global biopharmaceutical company based on research and development, which is committed to developing innovative and advanced therapies for some of the most complex and critical health conditions in the world.?The company's mission is to use its knowledge, dedicated team and focus on innovation to remarkably improve treatments in four main therapeutic areas: immunology, oncology, virology and neuroscience.?In more than 75 countries, AbbVie employees work daily to develop healthcare solutions for people around the world.?For more information about AbbVie, visit??www.abbvie.com??follow??@abbvie??on Twitter,??Facebook?,??LinkedIn??or??Instagram. In Brazil, AbbVie started operating in early 2014. Its local business units include immunology, neonatology, virology and oncology and, among its different areas of activity, it conducts more than 40 studies and clinical projects, involving more than 200 teams and Brazilian research centers?12?.?For more information, visit??www.abbvie.com.br References
(*)?https://www.reumatologia.org.br/doencas-reumaticas/artrite-reumatoide/??accessed on 12/4/2019???
(**) At?http://www.in.gov.br/web/ dou / - / resolucao-re-n-315-de-30-de-janeiro-de-2020-241100867??
1?Package insert for the product.?
2??Clark JD, Flanagan ME, Telliez JB.?Discovery and Development of Janus Kinase (JAK) Inhibitors for?Inflammatory Diseases.?J Med Chem 2014; 57: 5023?38?
3??Smolen JS?,??Pangan AL?,??Emery P?,??Rigby W?,??Tanaka Y?,??Vargas JI?,??Zhang Y?,??Damjanov N?,??Friedman A,??Othman AA?,??Camp HS?,??Cohen S?.??Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomized, placebo-controlled, double-blind phase 3 study.?Lancet 2019;?(8): 2303-2311.?doi: 10.1016 / S0140-6736 (19) 30419-2?
4?Fleischmann RM, Genovese MC, Enejosa JV, et al.?Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternate therapy in patients with insufficient response,?2019?.?Ann Rheum, doi: 10.1136 / annrheumdis?2019?215764?
5Burmester GR, et al.?Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomized, double-blind, placebo-controlled phase 3 trial.?Lancet.?2018; 391 (10139): 2503-2512.?doi: 10.1016 / S0140-6736 (18) 31115-2.?Epub 2018 Jun 18.?
6?Genovese MC, Fleischmann R, Combe B et al.?Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomized controlled phase 3 trial.Lancet 2018;?391 (10139): 2513-2524.?doi: 10.1016 / S0140-6736 (18) 31116-4?
7van Vollenhoven R, Takeuchi T, Pangan AL et al.?A Phase 3, Randomized, Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Na?ve Patients with Active Rheumatoid Arthritis [abstract].?Rheumatol arthritis.?2018;?70 (suppl 10).?https://acrabstracts.org/abstract/a-phase-3-randomized-controlled-trial-comparing-upadacitinib-monotherapy-to-mtx-monotherapy-in-mtxnaive-patients-with-active-rheumatoid-arthritis/?.?
8?Rivellese?F, Lobasso A, Barbieri L et al.?Novel Therapeutic Approaches in Rheumatoid Arthritis: Role of Janus Kinases Inhibitors.?Current Medicinal Chemistry 2018;?(25): 1-19?
9??Arthritis Foundation.What is Rheumatoid Arthritis.?Available at: https://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid- arthritis.php.?Accessed?7/9/2019?
10??Hunter T, et al.?Rheumatology International.?Prevalence of rheumatoid arthritis in the United States adult population in healthcare claims databases, 2004?2014.?April / 2017?
11?American College of Rheumatology.?Rheumatoid Arthritis.?Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Rheumatoid- Arthritis.?Accessed on?6/7/2019?
12?AbbVie??data, available at?https://news.abbvie.com/??and?https://www.abbvie.com.br/ AbbVie Brasil SOURCE
SOURCE AbbVie Brasil
