Core Insights - Rheumatologists express high satisfaction with AbbVie's Rinvoq (upadacitinib) following its approval for giant cell arteritis (GCA), highlighting anticipated efficacy, steroid-sparing benefits, and convenient oral administration as key factors for adoption [1] - Nearly all specialists are aware of Rinvoq's approval, with 40% already prescribing it for GCA patients, indicating a favorable early adoption compared to previous launches in ankylosing spondylitis and psoriatic arthritis [1] - Rinvoq is being initiated in the first-line advanced therapy setting for nearly half of current patients, reflecting an unmet need for effective oral alternatives [1] Adoption and Market Dynamics - Most rheumatologists foresee expanding Rinvoq's use in GCA, projecting peak adoption could reach nearly one-third of patients once fully established [2] - Despite safety concerns and payer hurdles, early data suggest Rinvoq is on track to become a significant competitor in the GCA market and may influence treatment decisions in polymyalgia rheumatica (PMR) [2] - Rinvoq's introduction is shifting perceptions around Genentech's Actemra (tocilizumab), with Rinvoq rated higher on convenience, speed of onset, and patient preference for oral administration [1] Safety and Cost Considerations - Physicians cite cardiovascular and thromboembolic risks in older GCA patients as significant safety concerns, alongside challenges related to Medicare coverage and out-of-pocket costs [1] - Despite these concerns, the majority of physicians view Rinvoq's overall risk-benefit profile as favorable, with over half indicating they are likely to recommend the therapy to colleagues [1] Off-Label Use and Future Outlook - One-quarter of rheumatologists anticipate increasing off-label use of Rinvoq in PMR, particularly for patients needing steroid-sparing strategies [1] - Rinvoq's oral administration and JAK1 selectivity are seen as advantages for some patients, although it has not yet been approved for PMR [1]

Core Viewpoint - AbbVie announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending the approval of upadacitinib (RINVOQ®) for treating adult patients with giant cell arteritis (GCA), with a final decision expected in the first half of 2025 [1][2]. Group 1: Product Information - Upadacitinib (RINVOQ) is a selective and reversible JAK inhibitor being studied for various immune-mediated inflammatory diseases, including GCA [7]. - If approved, upadacitinib would be the first and only oral advanced therapy for adults with GCA [1]. - RINVOQ is already approved in the EU for several conditions, including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis [2][8][12]. Group 2: Clinical Trial Data - The positive opinion is based on the pivotal Phase 3 SELECT-GCA clinical trial, which evaluated the efficacy and safety of upadacitinib in adults aged 50 and older with GCA [2][5]. - The trial involved 428 patients and demonstrated that the primary endpoint of sustained remission and key secondary endpoints were met [5][6]. - The safety profile of upadacitinib during the trial was consistent with that observed in other approved indications [2][5]. Group 3: Disease Background - GCA is an inflammatory disease that can lead to severe outcomes such as blindness and stroke if untreated [2][4]. - It is the most common vasculitis affecting adults in Western countries, with the highest risk among white women over 50 years old [4].