AbbVie’s Rinvoq (upadacitinib) has been granted marketing authorisation by the European Commission (EC) to treat giant cell arteritis (GCA), making it the first oral Janus kinase (JAK) inhibitor to be approved in the EU for adults with the autoimmune disease.
Also known as temporal arteritis, GCA causes inflammation of the temporal and other cranial arteries, the aorta and additional large and medium arteries.
The disease typically affects people aged over 50 years, particularly women, and can cause headaches, jaw pain and visual disturbances such as vision loss, as well as large artery complications and cardiovascular disease.
Rinvoq is already approved in the EU for certain cases of radiographic axial spondylarthritis, nonradiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn’s disease and atopic dermatitis.
“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 co-morbidities,” said Roopal Thakkar, executive vice president, research and development, chief scientific officer, AbbVie.
The regulator’s latest decision on the drug was based on positive results from the late-stage SELECT-GCA trial, in which 46.4% of patients being treated with Rinvoq in combination with a 26-week steroid taper regimen achieved sustained remission at week 52, compared with 29% of patients randomised to receive placebo alongside a 52-week steroid taper regimen.
Data also showed that 34.3% of patients in the Rinvoq cohort experienced at least one disease flare through week 52 versus 55.6% of patients in the placebo arm, and AbbVie’s drug was associated with lower cumulative steroid exposure and sustained complete remission.
SELECT-GCA trial investigator, Wolfgang Schmidt, Waldfriede Hospital, said: “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.
“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.”