AbbVie has received approval from the US Food and Drug Administration (FDA) for Rinvoq (upadacitinib), a 15 mg daily oral medication, to treat adults with giant cell arteritis (GCA).
Discovered and developed by AbbVie scientists, Rinvoq is a JAK inhibitor that has shown promise in various immune-mediated inflammatory diseases.
The drug is currently being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.
GCA is an autoimmune condition characterised by inflammation of the temporal and other cranial arteries, the aorta, and other large and medium arteries.
The FDA approval of Rinvoq follows the recent European Commission (EC) authorisation for the same indication.
AbbVie chief scientific officer, research and development executive vice president Roopal Thakkar said: “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.
“With this new indication for RINVOQ, we are underscoring AbbVie’s commitment to exploring how we can identify and address unmet needs for patients with immune-mediated diseases.”
The FDA approval is supported by the results from the Phase 3 SELECT-GCA clinical trial, which showed the efficacy and safety of Rinvoq.
The multicentre, randomised, double-blind, placebo-controlled study in 428 participants met its primary endpoint of sustained remission in GCA patients.
In the trial, 46.4% of patients receiving Rinvoq 15mg with a 26-week steroid taper achieved sustained remission, compared to 29% of those on a placebo with a 52-week taper.
The safety profile of Rinvoq during the 52-week placebo-controlled period was consistent with previous findings in other approved uses.
Rinvoq is also being investigated in Phase 3 trials for conditions such as alopecia areata, hidradenitis suppurativa, systemic lupus erythematosus, Takayasu arteritis, and vitiligo. In human leukocyte cellular assays, Rinvoq has shown potent inhibition of cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 compared to JAK2/JAK2.
The SELECT-GCA study comprises two periods. The first period assessed the efficacy of Rinvoq with a 26-week corticosteroid taper versus placebo with a 52-week taper. The second period will evaluate the long-term safety and efficacy of continuing versus withdrawing Rinvoq in maintaining remission in patients who achieved remission in the first period.
SELECT-GCA trial investigator Peter Merkel said: “Glucocorticoids remain a mainstay of treatment of GCA but lead to substantial drug-associated toxicities. Additionally, relapse remains common for patients with this disease.
“We now have a new option to treat GCA. The results of this clinical trial show that upadacitinib offers patients the chance to reach sustained remission.”
