AbbVie’s Rinvoq (upadacitinib) has been approved by the US Food and Drug Administration (FDA) to treat adults with giant cell arteritis (GCA), or temporal arteritis, an autoimmune disease of medium and large arteries.
The US regulator’s decision, which comes just three weeks after the European Commission approved Rinvoq for the same indication, was supported by results from the phase 3 SELECT-GCA trial.
In the study, 46.4% of patients receiving Rinvoq 15mg in combination with a 26-week steroid taper regimen achieved sustained remission at week 52, compared to 29% of patients randomised to receive placebo alongside a 52-week steroid taper regimen.
Additionally, data showed that 34.3% of patients being treated with the Rinvoq combination experienced at least one disease flare through week 52 versus 55.6% of patients in the placebo arm, and AbbVie’s drug was also associated with lower cumulative steroid exposure and sustained complete remission.
Occurring most frequently in women aged over 50 years, GCA can cause headaches, jaw pain and visual disturbances such as vision loss, as well as large artery complications and cardiovascular disease.
The current mainstay of treatment for the disease, glucocorticoids, can result in drug-associated toxicities, and relapse remains common.
AbbVie’s Rinvoq is now the first and only oral Janus kinase (JAK) inhibitor to be approved in the US for adults with GCA, and could allow patients to taper off steroids.
“This FDA approval will now provide an alternative treatment option that can offer patients with GCA the possibility of tapering off steroids and achieving sustained remission,” said Roopal Thakkar, executive vice president, research and development, chief scientific officer, AbbVie.
SELECT-GCA trial investigator, Peter Merkel, University of Pennsylvania, added: “We now have a new option to treat GCA. The results of this clinical trial show that [Rinvoq] offers patients the chance to reach sustained remission.”
Beyond GCA, Rinvoq is approved in the US to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis and Crohn’s disease.
The drug is also in phase 3 clinical development for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo.