RINVOQ Receives Health Canada Approval for Giant Cell Arteritis in Adults

AbbVie announced that Health Canada has granted a Notice of Compliance (NOC) for RINVOQ (upadacitinib) for the treatment of adults with giant cell arteritis (GCA). The approval includes use in combination with a tapering course of corticosteroids and as monotherapy after steroid discontinuation.

Giant cell arteritis is a serious autoimmune condition that causes inflammation in arteries, primarily affecting adults over 50. The disease, more common in women and people of northern European descent, can lead to severe complications such as permanent vision loss and stroke if not promptly treated.

“Steroids have been the mainstay of GCA therapy, but there is a high risk of toxicity and many patients experience relapses,” said Dr. Jean-Paul Makhzoum, a Canadian rheumatologist. “This announcement offers the first oral approach that has demonstrated meaningful control of disease activity in clinical trials.”

RINVOQ’s Canadian approval is based on results from the global Phase 3 SELECT-GCA trial, which showed that 46.4% of patients treated with RINVOQ 15 mg and a 26-week steroid taper achieved sustained remission between weeks 12 and 52—compared to 29.0% of patients on placebo and a 52-week steroid taper. The safety profile was consistent with previous RINVOQ indications.

Patient advocates welcomed the news. “GCA typically impacts patients in their early retirement years with life-altering consequences,” said Jon Stewart, President of Vasculitis Foundation Canada. “We look forward to a better future for GCA patients.”

One such patient, René St-Laurent from Rimouski, Québec, shared his experience: “After getting diagnosed with GCA, I was always tired. I joined a clinical trial [for RINVOQ] and got my energy back. I’m very active now and don’t have any more pain.”

Rami Fayed, General Manager of AbbVie Canada, emphasized the significance of the approval: “It provides an important option that may allow Canadian patients living with GCA to achieve sustained remission. This reflects AbbVie’s continued commitment to improving outcomes for people with autoimmune diseases.”