FDA Approves AbbVie's Rinvoq for Treating Giant Cell Arteritis

AbbVie's medication, Rinvoq (upadacitinib), has received approval from the U.S. Food and Drug Administration (FDA) for its use in treating adults diagnosed with giant cell arteritis (GCA), also known as temporal arteritis. This autoimmune disease affects medium and large arteries and is marked by symptoms such as headaches, jaw pain, visual disruptions including vision loss, and complications involving large arteries and cardiovascular issues. Women over the age of 50 are more frequently affected by this condition.

The FDA's approval follows closely behind a similar decision by the European Commission, which sanctioned Rinvoq for the same indication just three weeks earlier. The approval is significantly backed by findings from the phase 3 SELECT-GCA trial. In this study, Rinvoq was administered in a 15mg dosage alongside a 26-week course of tapering steroids, resulting in 46.4% of participants reaching sustained remission by week 52. This is in contrast to only 29% of participants who were given a placebo with a 52-week steroid taper regimen. Moreover, the use of Rinvoq led to a reduction in disease flares, with 34.3% of patients experiencing at least one flare by week 52 compared to 55.6% in the placebo group. The study also indicated that patients on Rinvoq had a lower cumulative exposure to steroids and achieved sustained complete remission more effectively.

Current treatments for GCA commonly involve glucocorticoids. Despite their widespread use, these treatments can be associated with significant drug-induced toxicities and a high likelihood of relapse. Rinvoq's approval introduces it as the first and only oral Janus kinase (JAK) inhibitor approved in the United States specifically for GCA in adults. The drug offers a new therapeutic approach that allows patients the possibility of reducing their dependency on steroids while achieving sustained remission.

The approval of Rinvoq offers a significant advancement in treatment options for patients with GCA. Roopal Thakkar, AbbVie's executive vice president, research and development, and chief scientific officer, emphasized the importance of this development, noting how it provides an alternative that allows patients to potentially taper off steroids and maintain remission. Peter Merkel, a trial investigator from the University of Pennsylvania, highlighted the clinical trial results, affirming Rinvoq as a beneficial option for achieving sustained remission in GCA patients.

Apart from its application in GCA, Rinvoq is already approved in the U.S. for other conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, and Crohn's disease. Additionally, Rinvoq is undergoing phase 3 clinical trials for conditions such as alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. The broadening of Rinvoq's applications underscores its potential impact on various autoimmune and inflammatory diseases, providing a promising option for patients and healthcare providers.