Deucravacitinib demonstrated comprehensive efficacy across multiple endpoints over the study duration. At Week 48, all doses (3 mg BID, 6 mg BID, and 12 mg QD) showed significant improvements in pain and fatigue compared to placebo, achieving minimal clinically important differences (MCID) for both symptoms. Patients treated with deucravacitinib also reported greater enhancements in SF-36 Mental Component Summary (MCS) and Physical Component Summary (PCS) scores relative to those receiving placebo, with noticeable numerical improvements in pain NRS, PROMIS Fatigue, SF-36 PCS, and SF-36 MCS scores observed across all dosage groups.

Moreover, at Week 32 and continuing through Week 48, patients with ≥6 active joints at baseline treated with deucravacitinib exhibited higher AJC-50 response rates compared to placebo (e.g., 63.5% for 3 mg BID vs. 45.3% for placebo), indicating sustained improvement in joint symptoms. Similar trends were observed for AJC-100, JC-50, and JC-100 responses across separate analyses of swollen and tender joint counts, demonstrating consistent efficacy throughout the treatment period.

Nevertheless, deucravacitinib 3 mg BID showed increased SRI (4), BICLA, CLASI-50, and JC-50 response rates compared to placebo across various patient subgroups, although interpretations for some subgroups were limited by smaller sample sizes.

Additionally, deucravacitinib significantly reduced the median time to first LLDAS response across all dosage groups compared to placebo (e.g., 28.0 weeks for 3 mg BID, 40.1 weeks for 6 mg BID, and 35.7 weeks for 12 mg QD), with higher percentages of patients achieving sustained LLDAS over ≥ 3 visits and cumulative time intervals of ≥ 20% and ≥ 50%, particularly in the 3 mg BID and 12 mg QD groups.

Furthermore, patients treated with deucravacitinib showed substantial improvements in skin manifestations from baseline to Week 48, with increased percentages achieving CLASI-50 and CLASI-70 responses across all evaluated cutaneous subtypes compared to placebo. This included sustained improvements in acute, subacute, chronic, and discoid cutaneous manifestations, highlighting the broad therapeutic benefit of deucravacitinib in managing skin symptoms in these patients.

Brief summaries of the key efficacy endpoints from the abstracts evaluating deucravacitinib in patients with active systemic lupus erythematosus are discussed below:

KOL insights

“Deucravacitinib represents a promising oral treatment option, originally developed for psoriasis but now showing potential in SLE management. Unlike traditional Janus kinase (JAK) inhibitors, deucravacitinib's selective inhibition of the TYK2 receptor offers a distinct mechanism of action. This specificity is pivotal, as it allows for effective modulation of immune pathways implicated in SLE without triggering the common side effects associated with broad JAK blockade. This targeted approach not only enhances safety but also underscores deucravacitinib's potential to address the multifaceted challenges of SLE while maintaining a favorable safety profile.” – Expert Opinion

Conclusion

The total market size of SLE in the 7MM is expected to reach USD 8.3 billion by 2034 with BENLYSTA, SAPHNELO,and Cenerimod expected to capture the major market. SLE is not only the prototypic systemic autoimmune disease but also one of the most heterogeneous illnesses treated by physicians; the heterogeneity presents immense challenges to diagnosis, treatment, and therapeutic advances. The development and implementation of new biologic therapies such as Litifilimab (Biogen), Ianalumab (Novartis), Nipocalimab (Johnson & Johnson). Small molecules such as Deucravacitinib (Bristol-Myers Squibb), Cenerimod (Idorsia Pharmaceuticals/Viatris),  Upadacitinib (AbbVie) among others, as well as CAR-T cell therapy such as Rapcabtagene autoleucel (Novartis), Descartes-08 (Cartesian Therapeutics), CABA-201 (Cabaletta Bio), and others are anticipated to broaden the treatment landscape for SLE patients in the upcoming years. These drugs are currently under clinical investigation and have demonstrated promising results.

The Phase II PAISLEY trial evaluating deucravacitinib in SLE highlights its potential therapeutic benefits across various disease manifestations. Early and sustained improvements were observed in mucocutaneous and musculoskeletal symptoms, with notable reductions in joint counts. These outcomes, particularly enhanced after glucocorticoid tapering, underscore deucravacitinib's independent efficacy. Significant responses in SRI (4), BICLA, CLASI‐50, and JC-50 across diverse patient subgroups further support its efficacy in managing SLE. Moreover, early achievement and prolonged maintenance of LLDAS and improved skin outcomes reinforce deucravacitinib's promise as a comprehensive treatment option for SLE. Ongoing Phase III trials will further validate these findings, with implications for improving clinical outcomes and quality of life in patients with this challenging autoimmune condition. 

 

As per DelveInsight, deucravacitinib is expected to capture ~USD 450 million by 2034 in the US. Overall, the increasing prevalence and intensive research and development in recent decades, with the approval of targeted therapies and a surging emerging pipeline with novel therapies with an improved mechanism of action, will fuel the market during the forecast period of 2024–2034.