2024-05-04 11:04:26
Since March, Spanish patients can access deucravacitinib, a TYK2 inhibitor that shows similar efficacy to adalimumab and ustekinumab.
Since March 1, deucravacitinib has been available for prescription in Spain (Sotyktu, by Bristol Myers Squibb). Within the growing arsenal of highly effective medications for plaque psoriasis, this drug has demonstrated long-term efficacy similar to first-generation biologics, with the advantage of oral administration.
This small molecule is the first drug in the tyrosine kinase 2 (TYK2) inhibitor class, which belongs to the janus kinase (JAK) family. Consulting firm Clarivate highlighted the potential of this treatment to change the psoriasis therapeutic paradigm in its list of notable launches in 2023. Deucravacitinib has been authorized for the once-daily treatment of moderate to severe plaque psoriasis in adults candidates for systemic treatment.
ACCESS
Anna López Ferrer, coordinator of the Psoriasis Group of the Spanish Academy of Dermatology and Venereology (AEDV) and deputy Dermatology Service of the Sant Pau Hospital (Barcelona), points out that it has a better safety profile than classic systemic drugs and that its results efficacy are aligned with first-generation biologics, “so, in terms of efficacy, deucravacitinib is a drug aimed at treating patients in the first therapeutic line.”
However, it warns that access in Spain is determined by its therapeutic positioning report, which “for reasons solely of efficiency”, places it in the second line, for patients without response or contraindications for use of anti-TNF drugs.
VERSUS APREMILAST
The phase III Poetyk PSO-1 and Poetyk PSO-2 clinical trials, which have evaluated the efficacy and safety of deucravacitinib in patients with moderate to severe psoriasis, have a direct comparison arm with the oral phosphodiesterase 4 inhibitor medication (PDE-4) apremilast.
The most important result of the comparison “indicates the superiority of deucravacitinib when evaluating PASI75 at week 16 of treatment,” the dermatologist understands. “This would be the main difference with the comparator apremilast, in addition to having a different safety profile, because it is based on a new mechanism of action.” Regarding long-term results, the Poetyk-LTE extension study found that 9 out of 10 patients who achieved PASI 75 response at week 16 maintained their response at 3 years.
In patients with psoriasis and scalp involvement, deucravacitinib achieves complete or almost complete clearance in 70% at week 16.
The trials also demonstrate efficacy in areas that are difficult to treat, such as the scalp, palmoplantar or nail involvement: 7 out of 10 patients with scalp involvement achieved complete or almost complete clearance at week 16; almost 6 out of 10 with palmoplantar involvement at week 24; and almost 5 out of 10 with nail involvement achieved a PGA-F 0/1 response at week 52.
COMPARISON WITH ORGANICS
Although the drug has not been compared in a clinical trial with biological drugs, “indirect comparison studies, which include data from the pivotal clinical trials of drugs that have studies in psoriasis, indicate that it would be at the level of the first-generation biological drugs such as adalimumab or ustekinumab,” explains López Ferrer.
The dermatologist indicates that “although the efficacy of deucravacitinib appears to be lower than that of more modern biologics according to these indirect comparisons, it is postulated as a therapeutic option for those patients where the oral route is the priority.”
SECURITY
Regarding the safety profile, the most frequently reported adverse reaction is upper respiratory tract infections. “The most important data on safety comes from pivotal clinical trials, with follow-up of patients for up to three years, which indicate that with deucravacitinib no new safety alerts appear beyond those already known by physicians who use systemic and biological drugs. for the treatment of psoriasis,” says the dermatologist. Naiara Brocal
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