The U.S. Food and Drug Administration approval of oral upadacitinib (Rinvoq) was supported by data from the phase III SELECT–giant cell arteritis trial, in which 46.4% of patients receiving the drug with a 26-week corticosteroid taper achieved sustained remission from week 12 to week 52 compared with 29.0% of those receiving placebo with a 52-week taper regimen (P = .002). The safety profile observed during the 52-week placebo-controlled period was generally consistent with previous indications.

Roopal Thakkar, MD, Executive Vice President of Research and Development as well as Chief Scientific Officer of AbbVie, stated: "This [U.S. Food and Drug Administration] approval will now provide an alternative treatment option that can offer patients with [giant cell arteritis] (GCA) the possibility of tapering off steroids and achieving sustained remission."

Peter A. Merkel, MD, MPH, Chief of Rheumatology at the University of Pennsylvania and investigator in the SELECT-GCA trial, stated: "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."

GCA is a large- and medium-vessel vasculitis that predominantly affects Caucasian women over 50 years of age, with peak incidence between 70 and 80 years. Men with GCA have a higher risk of ocular involvement. If untreated, GCA can result in vision loss, aortic aneurysm, or stroke.

Important safety considerations for upadacitinib include risks of serious infections, malignancies, major adverse cardiovascular events, thrombosis, and gastrointestinal perforations. Common adverse events include upper respiratory tract infections, herpes zoster, nausea, anemia, and elevations in liver enzymes and creatine phosphokinase. Patients should be monitored for infections, cardiovascular events, and hematologic abnormalities, and advised to avoid grapefruit-containing products during treatment.

Upadacitinib is now approved for multiple indications across rheumatology, gastroenterology, and dermatology, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, ulcerative colitis, Crohn’s disease, atopic dermatitis, and GCA. Study disclosures and further prescribing information are available through AbbVie.

Source: AbbVie