Biologic use for systemic lupus erythematosus (SLE) is increasing, with nearly 40% of moderate-to-severe SLE patients in the U.S. receiving these treatments. While GlaxoSmithKline’s Benlysta currently dominates the market, AstraZeneca’s Saphnelo is gaining traction, particularly for patients with skin manifestations, and its forthcoming subcutaneous version is expected to boost its use further. Despite increased biologic use, significant unmet needs persist, particularly regarding fatigue management and reducing reliance on long-term steroid use, highlighting the need for more effective therapies.
This evolving treatment landscape is crucial for both patients and the pharmaceutical industry. For patients, new therapies offer hope for better symptom control, reduced steroid dependence, and the possibility of achieving remission. The industry is incentivized to develop therapies addressing the shortcomings of current options, particularly those offering alternative administration routes or novel mechanisms of action, opening opportunities for market share gains.
Rinvoq (upadacitinib) and Sotyktu (deucravacitinib) are generating interest as convenient oral options, while Gazyva (obinutuzumab) shows promise for lupus nephritis. Litifilimab, with its novel mechanism of action and monthly subcutaneous dosing, has shown positive Phase 2 results, surpassing benchmarks for efficacy improvement compared to placebo. Further out, CAR T-cell therapy holds the potential to revolutionize SLE treatment, with some rheumatologists anticipating it could induce sustained or drug-free remission in a subset of patients.
The shift towards earlier biologic use in the disease course underscores the need for more effective and safer treatment options. The increasing willingness to prescribe biologics earlier, often replacing traditional DMARDs like azathioprine, signals a move towards more proactive management and a desire to minimize long-term steroid exposure. This trend, coupled with the robust pipeline of novel SLE therapies, suggests a significant evolution in the treatment paradigm in the coming years, potentially leading to better outcomes and a higher quality of life for individuals with SLE.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
