Shots:
- AbbVie adds an eighth indication to Rinvoq’s label with the European Commission’s approval for treating adult patients with giant cell arteritis (GCA)
- Sofie Berg, Therapeutic Area Head of International Immunology at AbbVie, in a conversation with PharmaShots, shares insights from the SELECT-GCA trial evaluating Rinvoq in GCA, highlighting both primary and secondary endpoints
- Rinvoq is currently being evaluated in Phase III trials for alopecia areata and vitiligo, with data expected in 2025. Data from the hidradenitis suppurativa and lupus programs are anticipated in 2026.
Saurabh: How does Rinvoq’s profile as the first oral JAK inhibitor for GCA differentiate it from existing treatments like glucocorticoids and tocilizumab (Actemra), and what specific unmet needs does it address for patients with this condition?
Sofie: Giant cell arteritis (GCA) is the most common form of vasculitis affecting adults in Western countries, primarily among White women over the age of 50. GCA has a high unmet patient need, as treatment for the condition often requires prolonged corticosteroid use, with limited alternative options. Glucocorticoids are the cornerstone of GCA treatment but continued use often results in toxicity and can lead to complications such as osteoporosis, cataracts and infections, among others.
Rinvoq is the first oral advanced therapy for adults living with GCA in the EU, which is differentiated from previously approved injection-administered therapies. Rinvoq preferentially inhibits signaling by JAK1 or JAK 1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2, providing a novel approach to treating the underlying inflammation in GCA. Results from the SELECT-GCA trial showed that Rinvoq can help patients achieve sustained remission and reduce their cumulative steroid exposure—effectively addressing two critical challenges in GCA management.
Saurabh: The SELECT-GCA trial showed 46.4% of patients achieved sustained remission with Rinvoq compared to 29% on placebo. Could you elaborate on the real-world significance of this difference for patients, particularly regarding quality-of-life improvements and long-term disease management?
Sofie: The initial treatment goal for GCA is rapid and complete disease control to prevent long-term complications and relapses, with ongoing management aimed at achieving and sustaining remission. GCA is commonly managed with glucocorticoid treatment which can have negative long-term effects. Rinvoq provides physicians with an additional tool to achieve these goals while reducing the burden of cumulative steroid exposure.
The SELECT-GCA trial met its primary endpoint of sustained remission, defined as an absence of GCA signs and symptoms from week 12 through week 52 and adherence to the protocol-defined steroid taper, and key secondary endpoints, including reduction in disease flares, lower cumulative steroid exposure and sustained complete remission.
What’s particularly significant is the real-world impact of sustained remission. For patients, the difference in sustained remission rates with Rinvoq vs. placebo can mean more stability in their day-to-day lives. This improvement can translate to less uncertainty about symptom recurrence and a greater ability to maintain normal daily activities and social engagements.
Saurabh: One of the key secondary endpoints showed significantly lower cumulative steroid exposure in the Rinvoq group. Given the well-documented adverse effects of long-term steroid use, particularly in older populations, how important is this steroid-sparing effect in the overall benefit profile of Rinvoq for GCA patients?
Sofie: Glucocorticoids are the mainstay of GCA treatment, but they have limitations. Prolonged glucocorticoid treatment often results in toxicity and can lead to complications such as osteoporosis, cataracts and infections, among others. Moreover, many patients treated with glucocorticoids alone experience disease relapse. By offering a treatment option that can help reduce cumulative steroid exposure while maintaining disease control, Rinvoq addresses one of the most challenging aspects of GCA management, particularly in an older patient population.
Saurabh: While Rinvoq has secured EU approval for GCA, the FDA application is still under review following submission in July 2024. What factors might influence the FDA’s decision timeline, and are there any specific considerations or challenges you anticipate in the US regulatory process?
Sofie: We’re pleased to share the U.S. Food and Drug Administration (FDA) has approved Rinvoq for the treatment of adults with giant cell arteritis (GCA). This marks the ninth approved indication for Rinvoq in the U.S.
Saurabh: Tocilizumab (ACTEMRA) has been the only other targeted therapy approved for GCA, with biosimilars recently entering the market. How does AbbVie plan to position Rinvoq competitively, especially considering its oral administration versus injectable alternatives?
Sofie: As the first and only JAK inhibitor approved for GCA in the European Union (EU), Rinvoq offers adult patients a new mechanism of action while providing flexibility in treatment options as an oral therapy, thereby removing the need for regular injections as required by tocilizumab.
Saurabh: Rinvoq is currently being studied in several other autoimmune conditions including alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. Which of these potential indications do you see as most promising, and what is the status of these clinical programs?
Sofie: We are pleased with the significant progress of our R&D efforts to advance novel clinical programs across all stages of our diversified pipeline. In 2025, we anticipate a strong cadence of important data readouts, regulatory submissions and new approvals, along with clinical trial starts for key programs.
For immunology, we are particularly enthusiastic about the data for two Phase 3 Rinvoq programs that will be available this year, focusing on alopecia areata and vitiligo. Additionally, we are looking forward to the data for our hidradenitis suppurativa and lupus programs in 2026.
Rinvoq now joins our growing portfolio of therapies for immunology conditions, marking its eighth approved indication in the EU including for the treatment of adults with radiographic axial spondylarthritis, nonradiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn’s disease, adults and adolescents with atopic dermatitis, and now adults with GCA.
For more detailed information regarding the status of our clinical programs, please visit our pipeline page: https://www.abbvie.com/science/pipeline.html
Saurabh: Given that GCA primarily affects older adults (70-80 years of age), what specific safety monitoring protocols has AbbVie implemented for this population, particularly regarding the known class risks of JAK inhibitors such as infections and cardiovascular events?
Sofie: At AbbVie, we are committed to advancing the standards of care for immune-mediated diseases and addressing unmet patient needs, today and in the future. During the 52-week, placebo-controlled period of the SELECT-GCA trial, the safety profile of Rinvoq was generally consistent with that observed in other approved indications.1
As with all treatments, when considering options for patients, it’s important to assess risk factors (e.g., age, comorbidities) for specific safety events. Clinical judgement and shared decision-making are critical in the benefit-risk determination to understand the most suitable treatment option.
Saurabh: Beyond the EU approval and pending FDA decision, what are AbbVie’s plans for seeking approvals for the GCA indication in other global markets, and how does the company prioritize these geographic expansions?
Sofie: AbbVie continues to evaluate the use of Rinvoq in GCA treatment. The second period of the SELECT-GCA trial is ongoing, which focuses on evaluating the safety and efficacy of continuing versus withdrawing Rinvoq in maintaining remission in participants who achieved sustained remission in the first period.1 Future evidence generation initiatives will be based on identified gaps that can inform the appropriated use of Rinvoq in GCA treatment.
About the Author:
Sofie Berg
Sofie joined AbbVie in 2013 as Medical Manager in the Swedish affiliate, leading the Gastroenterology team. In 2015. Sofie joined the Global Medical Affairs Gastro team as CD lead, and in February 2024, Sofie assumed her most recent role as TA Head Immunology, Global Medical Affairs & HEOR. Prior to joining AbbVie, Sofie held various regional medical roles within Dermatology, Gastroenterology, and Oncology within Centocor and Johnson & Johnson. Sofie obtained her Degree of Master of Science in Pharmacy and Degree of Master in Pharmaceutical Science from the University of Uppsala, Sweden in 2003, and her PhD in Medicine with focus on IBD from the Karolinska Institute, Sweden in 2006.
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