AbbVie today announced that the European Commission (EC) granted marketing authorization to RINVOQ® for the treatment of giant cell arteritis (GCA) in adult patients. RINVOQ is the first and only oral JAK inhibitor approved in the EU, as well as Iceland, Liechtenstein and Norway, for the treatment of adult patients with GCA.

"GCA is a challenging and often debilitating condition. Patients may endure headaches, jaw pain and muscle aches, with many fearing sudden and permanent vision loss,"said Prof. Dr. med. Wolfgang Schmidt, M.D., MACR, Waldfriede Hospital, Department of Rheumatology, Berlin, Germany, and SELECT-GCA trial investigator. "Results from the SELECT-GCA trial show that patients can achieve sustained remission and reduce their cumulative steroid exposure with RINVOQ, addressing important patient goals in the treatment of GCA."

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 patients older than 50 years, most commonly between the ages of 70 and 80 years.

"The EC approval of RINVOQ in GCA provides patients and physicians with a new treatment option and the first oral advanced therapy for adults living with GCA – a particularly vulnerable population due to older age and frequent comorbidities,"said Roopal Thakkar, M.D., executive vice president, research & development, chief scientific officer, AbbVie. "This exciting milestone demonstrates our commitment to ongoing research and expanding indications in areas of high unmet need to help patients achieve better outcomes, including sustained disease remission."

The EC approval is supported by data from the Phase 3 SELECT-GCA trial, which was recently published in the New England Journal of Medicine.1 In this trial, primary and key secondary endpoints were achieved with RINVOQ 15 mg and a week steroid taper regimen compared to placebo in combination with a 52-week steroid taper regimen.

Primary endpoint results from the Phase 3 SELECT-GCA trial demonstrated:

Sustained remission: 46.4% of patients receiving RINVOQ mg in combination with a week steroid taper regimen achieved sustained remission at week, compared with 29.0% of patients receiving placebo in combination with a week steroid taper regimen (p=0.002).

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. GCA can cause headache, jaw pain, and changes in or loss of vision, including sudden and permanent loss of vision.3 It is the most common vasculitis affecting adults in western countries.White women over the age of 50 – most commonly between the ages of 70 and 80 years – have the highest risk of developing GCA. Although women are more likely than men to develop GCA, research suggests that men are more likely to have ocular manifestations with their disease.6

About SELECT-GCA

SELECT-GCA 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 parts. The first part, which is reported in this release, evaluated the efficacy of upadacitinib in combination with a-week corticosteroid taper regimen compared with placebo in combination with a -week corticosteroid taper regimen. In addition, the study assessed the safety and tolerability of upadacitinib in these patients. The efficacy and safety of withdrawing versus continuing upadacitinib in maintaining remission in participants who achieved sustained remission in the first part will be evaluated in the second part of the study.

Top-line results of part one of the study were shared in April 2024. For more information regarding this study, please visit ClinicalTrials.gov (identifier: NCT03725202).

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.2,8 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK 1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.2 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.

 

Source: prnewswire.com

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