Psoriasis is a chronic, relapsing disease that usually requires long-term treatment. Treatment options are usually chosen clinically based on the severity of the psoriasis.
Mild to moderate psoriasis can be treated with topical glucocorticoids and D analogs.
Moderate to severe psoriasis usually requires phototherapy and systemic therapy.
In recent years, rapid progress has been made in the field of psoriasis treatment, especially the extensive research and clinical application of biological agents, which have been of great help to psoriasis patients.
1.What are the effective biological agents for psoriasis?
(1) Tumor necrosis factor-α inhibitor (TNF-α)
TNF-α is the earliest biologic agent for psoriasis on the market. Compared with traditional drugs, TNF-α inhibitors can theoretically reduce the risk of potential end-organ damage.
Currently, there are five main TNF-α inhibitors: etanercept, infliximab, adalimumab, certolizumab and golimumab, and the first three are more frequently used in China.
Common indications include rheumatoid arthritis, ankylosing spondylitis, arthritic psoriasis, and moderate-to-severe plaque psoriasis in adults.
Common adverse effects of TNF-α inhibitors are injection site reactions, upper respiratory tract infections, elevated antinuclear antibodies, and lupus-like reactions.
(2) Interleukin-12/interleukin-23 inhibitors
At present, there is only one IL-12/IL-23 inhibitor, i.e. Usnumab, available for clinical use in China.
Usnumab injection was approved by the US FDA in 2009, and the approved indications include adolescents and adults aged 12 and above with moderate or severe plaque psoriasis suitable for phototherapy or systemic therapy; as a single agent or in combination with methotrexate for adults aged 18 and above with active arthritic psoriasis; and adults aged 18 and above with Crohn’s disease who have failed or are intolerant to treatment with other drugs.
The drug was approved in China in February 2019, and approved indications include adult patients with moderate or severe plaque psoriasis who have failed to respond to, are contraindicated by, or are intolerant to other systemic therapies such as cyclosporine, methotrexate, or photochemotherapy.
Adverse events with short- and long-term use of ustekinumab are predominantly nasopharyngitis, and long-term use can also lead to elevated creatine kinase levels and seasonal allergic symptoms.
(3) Interleukin-17A inhibitors
Cytokines of the IL-17 family have emerged as important pro-inflammatory factors in psoriasis and psoriatic arthritis. The IL-17A inhibitors currently available in China include secukizumab and echizumab.
Sikulchizumab is a fully human IgG1κ antibody that specifically inhibits IL-17A and was launched late. in August 2021, the Chinese NMPA approved sikulchizumab for the treatment of moderate and severe plaque psoriasis in children and adolescents aged 6 years and above weighing ≥50 kg, adding another opportunity for the treatment of psoriasis in children.
The efficacy of echizumab and secukizumab in the regression of psoriasis lesions is similar. In terms of safety, in addition to upper respiratory tract infections, this class of drugs may aggravate inflammatory bowel disease and requires attention when applied.
(4) Interleukin-23 inhibitors
At present, there are four kinds of IL-23 inhibitors in foreign countries, among which the commonly used one is guselkizumab.
The common adverse reactions are nasopharyngitis and upper respiratory tract infection, in addition to headache, arthralgia, and erythema at the injection site. Therefore, it is necessary to evaluate the efficacy for selection when using.
2.How to apply biologics in special populations?
Biological agents, as the current research hotspots, have better safety and therapeutic effects compared with traditional drugs.
How to apply biologics to special groups such as pregnant women, lactating women, children, patients with chronic infections, patients with malignant tumors and vaccinated patients?
(1) Pregnancy
Further research and demonstration are needed to determine whether patients with psoriasis during pregnancy can be treated with biological agents.
Theoretically, if treatment with biologics is used, appropriate contraception is needed according to the medication. If no other treatment options are available, the use of TNF-α inhibitors during the first trimester of pregnancy may be considered.
For the treatment of psoriasis during pregnancy, topical medications can be used as commonly used first-line drugs, such as glucocorticoids, which can reduce the impact on fetal malformations, preterm delivery and stillbirth.
(2) Lactation
The use of TNF-α inhibitors during breastfeeding is of minimal risk to breastfed newborns. Ustekinumab, secukizumab, ixekizumab and guselkizumab are not recommended for use during breastfeeding for the time being.
(3) Children
TNF-α inhibitors, ustekinumab, secukizumab, and guselkizumab can be selected for treatment, all of which have a certain degree of safety.
(4) Patients with malignant tumors
Patients with malignant tumors that have been treated with radical surgery for more than 5 years without recurrence or metastasis can be considered for treatment with biological agents. For patients with combined malignant tumors of lymphatic system, the use of biologic therapy is not recommended.
(5) Patients with vaccination
Inactivated vaccines and recombinant vaccines can be administered during the use of biological agents, but there is no uniform conclusion whether the use of biological agents should be stopped before the injection.
For TNF-α blockers, it is recommended that biologics be discontinued for 1 to 2 half-lives prior to vaccination and treatment be continued 1 to 2 weeks after vaccination.
Discontinuation is not required for inactivated or recombinant vaccines administered during the use of IL-17 inhibitors.
Discontinuation of biologics for 6 to 12 months is recommended prior to live vaccination, and herpes zoster vaccination requires 12 months of discontinuation of biologics. Biologic therapy is recommended 4 weeks after live vaccination.
Biologics are usually excluded from clinical trials in special psoriasis patient groups, such as pregnant women, lactating women, children, patients with chronic infections, patients with malignancies and vaccinated patients, and relevant data and clinically observed cases are limited, resulting in limitations and some difficulties in the application of biologics in such patients.
References
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[2]Wang Yun,Wang Mingyue,Xia Yang,Tu Ping,Li Ruoyu,Li Hang. Advances in the treatment of psoriasis with biologic agents[J]. Chinese Journal of Frontiers in Medicine (Electronic Edition),2021,13(12):13-18.
[3]Zhang Hanlin,Shu Chang,Jin Hongzhong. Research progress of biological agents in the treatment of psoriasis[J]. China Science (Life Science),2021,51(08):1050-1059.
[4] Tan Zhouxia. Treatment modalities of psoriasis in special populations[J]. Frontiers in medicine,2017,7(29):89-90.
[5]Yue Y,Zheng Lisheng,Liu Wei. Research progress of biologic agents for the treatment of psoriasis[J]. Modern Drugs and Clinics,2014,29(08):940-946.