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AbbVie's Rinvoq Approved for Treating Giant Cell Arteritis in Adults

AbbVie announced that the European Commission (EC) has granted marketing authorization for Rinvoq (upadacitinib) as a treatment for adults diagnosed with Giant Cell Arteritis (GCA). This significant approval marks the introduction of the first oral Janus Kinase (JAK) inhibitor available for GCA patients in the European Union (EU), including Iceland, Liechtenstein, and Norway. This regulatory milestone is based on the positive outcomes from the pivotal Phase III SELECT-GCA trial, where Rinvoq demonstrated impressive results in maintaining remission, reducing flares, and decreasing cumulative steroid use among the participants.

The SELECT-GCA trial was a multicenter, randomized, double-blind, placebo-controlled study involving 428 patients diagnosed with GCA. Its primary endpoint was remission maintenance, defined as the absence of GCA symptoms for 12 weeks during the treatment period, while adhering to a tapered steroid regimen. Participants receiving Rinvoq showed not only significant maintenance of remission but also benefited from less frequent flare-ups and a marked reduction in the amount of steroids needed.

GCA is an autoimmune condition characterized by inflammation of large and medium-sized arteries in the head, such as the temporal arteries, often manifesting with debilitating symptoms like headaches, jaw pain, and severe complications including sudden and permanent vision loss. It typically affects older adults, with a majority of cases occurring in individuals aged 70 to 80 years.

Professor Wolfgang Schmidt M.D., a prominent rheumatologist at the Waldfriede Hospital in Berlin and lead investigator of the SELECT-GCA trial, commented on the condition's impact: "GCA can be a debilitating illness for patients, often leading to chronic symptoms and serious complications. Our trial results indicate that Rinvoq represents a significant advancement in pursuing effective long-term treatment options that can help patients maintain remission and reduce their reliance on steroids."

Roopal Thakkar, M.D., AbbVie’s Executive Vice President and Chief Scientific Officer stated, "The EC's approval of Rinvoq as a treatment option for GCA patients signifies our commitment to providing innovative therapies to those suffering from this challenging disease, especially considering the complexities and health risks faced by older patients. We aim to continue our research efforts to meet the unmet needs in this area."

The favorable safety profile of Rinvoq in the SELECT-GCA trial aligned closely with previously established therapies, with serious adverse events appearing in a comparable percentage of patients across the Rinvoq and placebo groups. Notably, the incidence of serious infections was slightly lower in the Rinvoq group compared to the placebo group, reinforcing the safety of the treatment. The trial’s results found that two deaths occurred in both the Rinvoq and placebo arms of the study, with one in the Rinvoq group attributed to COVID-19.

Rinvoq is also approved in Europe for the treatment of several other immune-mediated inflammatory diseases, including ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, Crohn's disease, rheumatoid arthritis, atopic dermatitis, and more.

The approval for Rinvoq in the EU for treating GCA adds to the list of indications for this promising oral therapy and opens new avenues for patient management in rheumatology. The drug's effectiveness in helping patients navigate the complexities of GCA underlines AbbVie's ongoing dedication to innovative solutions for inflammatory diseases.

For further information on this innovative treatment, visit the official AbbVie website or check updates on their latest research and future endeavors in the field of rheumatology.