EXTON, PA, Oct. 18, 2024 (GLOBE NEWSWIRE) -- Dermatomyositis (DM) is a rare inflammatory disease characterized by muscle weakness and a distinctive skin rash. Currently, the standard of care predominantly involves corticosteroids, topical therapies, traditional disease-modifying anti-rheumatic drugs (tDMARDs), and, in more severe or refractory cases, intravenous immunoglobulin (IVIg) or off-label biologics, underscoring the growing unmet need for novel therapeutic options to treat this condition.
Spherix Global Insights recently engaged 102 US rheumatologists and dermatologists to assess the current treatment landscape, identify gaps in care, and evaluate the future potential of pipeline therapies for DM. The study's findings reveal a substantial unmet need for new steroid-sparing treatment options for both classic and clinically amyopathic (skin only) dermatomyositis (CDM and CADM, respectively). Specifically, specialists report that over half of DM patients are not optimally managed on their current treatment, with CDM patients faring somewhat worse overall.
Specialists confirm that corticosteroids remain the most frequently prescribed first-line treatment for DM, followed by tDMARDs such as methotrexate and mycophenolate mofetil, as well as IVIg and off-label biologics like rituximab. However, treatment approaches are evolving, with over two-thirds of rheumatologists and nearly half of dermatologists reporting changes in their management of DM over the past year. These shifts often involve increased or earlier use of IVIg, more frequent patient visits, and a growing reliance on off-label advanced systemic therapies aimed at reducing steroid dependence.
In the absence of therapeutic advancements, the vast majority of rheumatologists and dermatologists express an extremely high unmet need for new pharmacological treatment options for DM. As one respondent highlighted, “[the greatest challenge in managing DM is the] lack of safe and tolerable medications – many have seriously bad safety profiles and poor risk-reward ratios.”
Treaters emphasize there is a pressing need for a safe, effective agent that is steroid-sparing, addresses both skin and muscle involvement, and that targets the underlying causes of the disease rather than just alleviating symptoms. Furthermore, respondents report that the majority of their classic DM and half of CADM patients would be considered candidates for new advanced systemic therapies.
Focusing on the pipeline, respondents were provided with target product profiles for AstraZeneca’s Saphnelo, Priovant Therapeutics’ brepocitinib, Pfizer’s dazukibart, CSL Behring’s Hizentra, and Amgen/Horizon’s daxdilimab to gauge specialist feedback on overall likelihood to prescribe, degree of advancement, patient candidacy, and anticipated timeline for use upon approval. A key difference between specialties emerged, with rheumatologists favoring Saphnelo (AZ) due to their familiarity with the agent in systemic lupus erythematosus (SLE), and dermatologists leaning towards Priovant’s JAK1/TYK2 brepocitinib, valuing its oral route of administration and unique but familiar mechanism of action.
While Saphnelo and brepocitinib have garnered higher rates of preference, CSL Behring’s Hizentra may also play a pivotal role in filling the noted unmet need, if approved. Unlike other immune globulin agents currently in use like Pfizer’s Octagam 10%, Hizentra offers the convenience of subcutaneous injection, eliminating the need for IV access—a key advantage for DM treaters, with over half expressing a preference for new therapies that can be administered via injection at home.
Specialists view the convenience of Hizentra's subcutaneous dosing as a significant benefit, along with its mechanism of action, which is well understood due to the widespread experience with IVIg and its proven efficacy. Consequently, it's not surprising that a majority anticipate trialing Hizentra within the first six months of its potential approval, estimating a sizeable portion of their DM patients would be suitable candidates. As one specialist reports, “[It is a] familiar MOA, I would feel comfortable prescribing and feel it is definitely indicated/justifiable depending on the extent of disease.”
Spherix will continue to monitor the myositis landscape in 2025, broadening coverage to include additional forms of idiopathic inflammatory myopathies (IIM), as well as tracking the potential launch of Hizentra in DM, should it gain FDA approval.
Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a paradigm shift within the next three to five years. Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents.
Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand.
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