Upadacitinib Looks Promising for Patients With Giant Cell Arteritis

Patients with giant cell arteritis (GCA) who received upadacitinib with a steroid taper regimen achieved sustained remission, according to results from the phase 3 SELECT-GCA study.

The randomized, double-blind, placebo-controlled, SELECT-GCA study (ClinicalTrials.gov Identifier: NCT03725202) evaluated the efficacy and safety of upadacitinib in patients 50 years of age and older with GCA. Study participants were randomly assigned to receive either upadacitinib or placebo orally once daily, in combination with a 26-week steroid taper regimen. 

The primary endpoint was the percentage of patients who achieved sustained remission at week 52, defined as having achieved absence of GCA signs and symptoms from week 12 through week 52, and adherence to the protocol-defined steroid taper regimen. Findings showed 46% of patients treated with upadacitinib 15mg achieved sustained remission compared with 29% of those who received placebo (P =.0019). 

Moreover, 37% of patients in the upadacitinib 15mg arm achieved sustained complete remission (secondary endpoint) compared with 16% of those in the placebo arm (P <.0001). Sustained complete remission was defined as having an absence of GCA signs and symptoms from week 12 through week 52, adherence to the protocol-defined steroid taper, and normalization of both erythrocyte sedimentation rate and high sensitivity C-reactive protein from week 12 through week 52.

In the upadacitinib 15mg arm, fewer patients experienced at least 1 disease flare through week 52 compared with the placebo arm (34% vs 56%, respectively; P =.0014). No new safety signals were identified in the trial.

“I am encouraged by these results, which add to the body of evidence supporting the efficacy and safety profile of upadacitinib for the treatment of rheumatic diseases,” said Daniel Blockmans, MD, PhD, Department of General Internal Medicine, University Hospitals Gasthuisberg, Belgium, professor of medicine, KU Leuven, Belgium, and lead investigator of the SELECT-GCA trial. “Based on these results, upadacitinib has the potential to be the first oral treatment option for patients with GCA, a disease with inflammation of the large arteries that primarily impacts older people and has only one approved treatment to date commonly used with steroids.”

Full study results will be presented at a future medical meeting.

Upadacitinib, a Janus kinase (JAK) inhibitor, is currently approved under the brand name Rinvoq^® for rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn disease, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.