Executives from AbbVie (NYSE:ABBV) outlined upcoming clinical milestones and development priorities across hidradenitis suppurativa (HS), inflammatory bowel disease (IBD), and several earlier-stage immunology programs during a recent discussion focused on differentiation, combination strategies, and next-generation platforms.
HS: IL-1 bispecific lutikizumab and RINVOQ readouts expected by year-end
Company leaders emphasized that HS remains a significant unmet-need area and highlighted AbbVie’s long history in the indication, noting HUMIRA was the first medicine approved for HS. They said AbbVie’s current HS strategy centers on targeted development of lutikizumab (an IL-1 alpha/IL-1 beta bispecific) and RINVOQ, with an emphasis on clinical differentiation in both biologic-naive and biologic-experienced populations.
On clinical data, AbbVie characterized lutikizumab’s phase 2 results as “really strong,” including in TNF-experienced patients as well as a separate treatment-naive cohort. Management also noted that the original phase 2 TNF-failure group included a high proportion of advanced disease, including many patients described as early stage three with draining fistulas and tunnels.
Looking ahead, the company said it has opened a phase 2 program that includes both biologic-experienced and biologic-naive patients for lutikizumab, while RINVOQ development in HS is focused on a 100% TNF-experienced population. AbbVie said both programs are expected to have double-blind week 16 data by the end of this year.
Competitive framing in HS: safety, immunogenicity, and IL-1 alpha/beta rationale
In discussing the HS development landscape, AbbVie addressed several external approaches and highlighted considerations that could influence differentiation. Management referenced recent developments in OX40 programs in atopic dermatitis, including discussion of Kaposi’s sarcoma events, and said that dermatology prescribing can be sensitive to signals suggesting stronger immunosuppression over long-term use.
They also discussed challenges that can arise with anti-TNF bispecifics, including immunogenicity. AbbVie cited its own historical experience with a TNF-17 program that had a high level of immunogenicity, suggesting that “making bispecifics with anti-TNFs” can be more difficult.
On IL-1 strategies, executives reiterated their preference for targeting IL-1 alpha as well as IL-1 beta, noting IL-1 alpha’s role in epidermal damage signaling and potential implications such as increased angiogenesis and inflammation. They argued that blocking both cytokines may also help address compensatory mechanisms.
IBD: subcutaneous SKYRIZI data and a broad combination roadmap
In IBD, AbbVie previewed multiple readouts and positioned combination therapy as a path toward higher efficacy, deeper remission, and more durable outcomes. Management said subcutaneous data for SKYRIZI are expected this year and could be important competitively in a market where some rivals offer subcutaneous options. AbbVie added that it currently sees strong front-line share for SKYRIZI and believes a subcutaneous option could further support usage.
On combinations, AbbVie described a mix of “precedented” and novel mechanisms under evaluation alongside SKYRIZI. They highlighted several approaches they see as orthogonal to IL-23:
- Alpha-4 beta-7: described as a more potent version compared with vedolizumab; a readout is expected this year.
- TL1A: AbbVie said TL1A has shown convincing phase 2 efficacy across the class, particularly stronger in ulcerative colitis than Crohn’s disease; SKYRIZI/TL1A combination studies are expected to start later this year.
- Lutikizumab: AbbVie said it looked numerically better than HUMIRA in ulcerative colitis but not as high as desired, and it will be tested in Crohn’s disease, including in combination with alpha-4 beta-7.
- TREM1: positioned as a unique, upstream inflammation-amplification mechanism with proof-of-concept expected later this year or early next year.
TL1A: combination strategy, biomarkers, and possible anti-fibrotic relevance
Management said TL1A is a mechanism AbbVie views as validated by multiple phase 2 datasets, but they did not see differentiated efficacy versus SKYRIZI or RINVOQ based on what had been available to date. As a result, AbbVie said its strategy is to pursue combination approaches to “break that efficacy ceiling,” while maintaining safety and offering convenience through potential co-formulations.
AbbVie also discussed biomarkers as a potential future path to more individualized treatment in IBD and immunology, though executives noted immunology has been more challenging than oncology in identifying robust predictive biomarkers. The company said it continues to collect tissue samples in studies and work with internal precision medicine efforts, and noted TL1A had shown “glimpses” of biomarker potential.
On broader development potential for its TL1A asset, the company said TL1A has preclinical support for anti-fibrotic activity and noted that unchecked inflammation can lead to irreversible fibrosis. AbbVie said diseases such as rheumatoid arthritis, psoriatic arthritis, HS, and systemic sclerosis are on its radar for potential future consideration. The company also referenced an internal LPAR program that has entered the clinic and is aimed at immune and fibrosis biology, including programs in idiopathic pulmonary fibrosis and sclerosis.
Earlier-stage platforms: oral IL-23 ambitions and B-cell-focused programs
AbbVie also outlined its rationale for pursuing an oral IL-23 program through its Nimble deal, emphasizing goals of higher potency and longer half-life. Executives said adherence can be difficult with daily oral therapies and argued that maximizing IL-23 blockade is important to deliver outcomes comparable to SKYRIZI across psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. They added that oral IL-23 data seen to date have not matched SKYRIZI-like efficacy, which they attributed in part to half-life and potency limitations.
In B-cell-directed approaches, AbbVie discussed an antibody-drug conjugate program referred to as 319, described as a CD19-targeting ADC with a steroid payload. Executives said the program combines three mechanisms: delivering steroid to B-cells, inhibiting CD19 activation, and antibody-dependent killing. They also referenced an additional related asset, ABBV-519, described as the same antibody without the payload, which they said could be used as a steroid-free option for maintenance or boosting if needed. Separately, the company noted a Capstan partnership for an “in situ lipid nanoparticle CAR-T” approach, describing it as not requiring lymphodepletion, lacking DNA integration, tunable, re-dosable, and transiently expressed.
About AbbVie (NYSE:ABBV)
AbbVie is a global, research-driven biopharmaceutical company that was created as a spin-off from Abbott Laboratories in 2013 and is headquartered in North Chicago, Illinois. The company focuses on discovering, developing and commercializing therapies for complex and often chronic medical conditions. Its operations span research and development, manufacturing, regulatory affairs and commercialization, with an emphasis on bringing specialty medicines to market across multiple therapeutic areas.
AbbVie’s product portfolio and pipeline cover several major therapeutic categories, including immunology, oncology, neuroscience, virology and women’s health.
