Systemic Therapies For Psoriasis Research Articles

Systemic therapy for psoriasis and the risk of cutaneous infections.

Systemic treatments are important for patients with moderate-to-severe psoriasis; however, they may occasionally cause adverse infectious events. Although the risk of severe infections with psoriatic treatments is well established, little is known about cutaneous infections. Therefore, we studied the frequency of cutaneous infections in patients with psoriasis who underwent biologic treatment. A total of 878 patients (237 females and 641 males) were analyzed in this follow-up survey conducted in 2020 and based on the Western Japan Psoriasis Registry. The observed skin phenotypes were psoriasis vulgaris (83.3%), pustular psoriasis (7.5%), and psoriatic arthritis (28.9%). The most frequently prescribed systemic drug was apremilast (11.3%), followed by ixekizumab (11.0%), risankizumab (10.9%), and secukinumab (10.4%). The incidence of cutaneous bacterial infections was 12 (1.37% of the total patients), with cellulitis being the most common (8/12, 67%). The incidence of viral infections was 11 (1.25%) including the most common, herpes zoster (9/11, 82%); and that of fungal infections was 45 (5.13%) including 33 (73%) and seven (16%) patients with trichophytosis and oral candidiasis, respectively. Multivariate analysis revealed that cutaneous bacterial infections were frequently observed in patients receiving tumor necrosis factor-α (odds raio [OR] 9.917, 95% confidence interval [CI] 2.069-47.572, p = 0.004) and interleukin (IL)-17 (OR 10.798, 95% CI 2.35-49.616, p = 0.002) inhibitor treatments. A history of otitis media and treatment with oral medications (OR 4.50, 95% CI 1.281-15.804, p = 0.019 and OR 3.80, 95% CI 1.141-12.679, p = 0.03 respectively) were associated with a higher ORs for cutaneous viral infections. Furthermore, age and use of IL-17 inhibitors were associated with elevated ORs for fungal infections. In conclusion, our study reveals that systemic therapies may increase the risk of cutaneous viral infections. Therefore, dermatologists should exercise caution in this regard.

Vaccination recommendations for adults receiving biologics and oral therapies for psoriasis and psoriatic arthritis: Delphi consensus from the medical board of the National Psoriasis Foundation

For psoriatic patients who need to receive nonlive or live vaccines, evidence-based recommendations are needed regarding whether to pause or continue systemic therapies for psoriasis and/or psoriatic arthritis. To evaluate literature regarding vaccine efficacy and safety and to generate consensus-based recommendations for adults receiving systemic therapies for psoriasis and/or psoriatic arthritis receiving nonlive or live vaccines. Using a modified Delphi process, 22 consensus statements were developed by the National Psoriasis Foundation Medical Board and COVID-19 Task Force, and infectious disease experts. Key recommendations include continuing most oral and biologic therapies without modification for patients receiving nonlive vaccines; consider interruption of methotrexate for nonlive vaccines. For patients receiving live vaccines, discontinue most oral and biologic medications before and after administration of livevaccine. Specific recommendations include discontinuing most biologic therapies, except for abatacept, for 2-3 half-lives before live vaccine administration and deferring next dose 2-4weeks after live vaccination. Studies regarding infection rates after vaccination are lacking. Interruption of antipsoriatic oral and biologic therapies is generally not necessary for patients receiving nonlive vaccines. Temporary interruption of oral and biologic therapies before and after administration of live vaccines is recommended in most cases.

Topical Cycling: The Obstacles to Moving Forward with Systemic Psoriasis Therapies and How to Characterize the Systemic Ready Patient

Background: Psoriasis is a chronic, inflammatory disease with numerous negative physical and psychosocial impacts. Topicals are a mainstay of treatment, particularly for disease with minimal skin involvement, but they are limited due to an inability to target systemic symptoms and a lack of convenience, patient adherence, and patient satisfaction. Given its systemic implications, many patients with psoriasis are undertreated including those with limited body surface area (BSA) involvement. With a growing role in providing dermatological services, physician assistants and nurse practitioners can benefit from additional guidance on how to appropriately treat these patients, as the current clinical recommendations require further expansion, and the criteria for what qualifies as adequate treatment and response are incomplete. Methods: Two comprehensive literature searches of PubMed, Scopus, and Google Scholar were completed for English-language original research articles on the use of topical versus systemic medications for psoriasis and its comorbidities. A panel of 11 dermatology physician assistants and nurse practitioners with expertise in managing psoriatic disease gathered to review the selected literature and form consensus statements with clinical recommendations for treating psoriasis. A modified Delphi process was employed to approve each statement and a strength of recommendation was assigned to each statement using the Strength of Recommendation Taxonomy (SORT) criteria. Results: The two literature searches produced 98 and 76 articles, respectively, that met search criteria. After screening the articles for relevance to the discussion topic, 19 articles were distributed to the panelists for review prior to the roundtable discussion. The panel unanimously voted to adopt 10 consensus statements and recommendations, 4 of which were given a strength of “A”, 1 of which was given a strength of “B”, and 5 of which were given a strength of “C”. Conclusion: Psoriasis is a systemic disease with cutaneous manifestations and should be considered as such for adequate treatment. The 10 consensus statements created by the experts provide clinical recommendations on the systemic effects of psoriasis and important treatment considerations that can help guide clinicians on how to appropriately treat psoriasis of all severities. Furthermore, an emphasis is placed on recognizing treatment goals and making the next appropriate clinical decision for patients with mild to moderate disease who fail topical therapy.

A novel variant with a severe phenotype in a patient with CARD14-associated papulosquamous eruption successfully treated with ixekizumab.

CARD14-associated papulosquamous eruption (CAPE) is an autosomal dominant disorder characterized by early onset of symptoms, prominent facial involvement, clinical manifestations resembling both psoriasis and pityriasis rubra pilaris (PRP), family history of psoriasis or PRP and limited response to conventional topical and systemic therapies for psoriasis or PRP. Here, we describe the clinical features of a patient with CAPE and a novel mutation of CARD14.

Predictive factors of psoriatic arthritis in a diverse population with psoriasis.

We aimed to analyze the clinical characteristics of patients with psoriasis and determine the predictive factors of psoriatic arthritis (PsA). This retrospective cohort study was performed among patients with psoriasis. Demographic and clinical data were collected. Psoriasis treatment was categorized as topical agents, phototherapy, oral therapy, and biologics. Predictive factors of PsA development were determined using logistic regression analyses. We included 330 patients with psoriasis, and 83 (25%) patients developed PsA. Thirty-eight (45.8%) patients who developed PsA were Malay, 24 (28.9%) were Chinese, and 21 (25.3%) were Indian. The mean age of patients with PsA was 54.2 (±15.8) years, and the duration from diagnosis of psoriasis to diagnosis of PsA was 36 (3.5-114) months. Predictive factors for developing PsA were female sex (odds ratio [OR] = 3.33, 95% confidence interval [CI] 1.78-6.22), presence of nail involvement (OR = 5.36, 95% CI 2.50-11.51), severe psoriasis (OR = 27.41, 95% CI 7.58-99.11), and oral systemic therapy prior to PsA diagnosis (OR = 4.09, 95% CI 2.04-8.22). Patients with psoriasis who are female, have nail involvement, severe skin psoriasis, and require oral systemic therapy for psoriasis may have an increased risk of developing PsA.

From pathogenesis to current treatment of the cutaneous psoriasis - a literature review

Introduction:
 Psoriasis is a chronic inflammatory autoimmune disease that can be divided into several subtypes based on the areas of the body occupied by the lesions and the severity of the disease. The overall prevalence of psoriasis ranges from 0 to 11,8%. The disease occurs with equal frequency in both sexes. PsO cannot be completely cured, so many patients experience stigma and have diminished self-esteem due to the characteristic appearance of the lesions.
 
 Aim of the study:
 The purpose of the study is to summarize the available knowledge about classification and options for psoriasis treatment. The options in diagnosis and treatment, including the latest methods, were described and summarized.
 
 Materials and methods:
 Literature available in the PubMed database was reviewed using the following keywords: “Psoriasis”, “Nail Psoriasis”, “Psoriasis Vulgaris”, “Psoriasis Treatment”, “New Psoriasis Treatment”, “Psoriasis Classification”, “Biologic Therapy for Psoriasis”, “Systemic Therapy for psoriasis”.
 
 Conclusions: 
 Psoriasis is a genetic skin condition mediated by the immune system. The underlying mechanisms entail intricate interactions between the innate and adaptive immune system. There are various indices for assessing the severity of psoriasis, the most commonly used of which is PASI(Psoriasis Area and Severity Index). Retinoids, cyclosporine and methotrexate are the non-biologic therapies most frequently employed for moderate to severe psoriasis treatment, while topical therapy, which includes mainly corticosteroids and vitamin D analogues, is a successful approach for effectively managing mild psoriasis.

Sex differences in adverse events from systemic treatments for psoriasis: A decade of insights from the Swiss Psoriasis Registry (SDNTT).

Psoriasis is a disease that often requires prolonged systemic treatment. It is important to determine the safety of available therapies. There is currently little insight into sex-specific differences in the safety of systemic psoriasis therapies. To examine the real-world, long-term safety of systemic psoriasis therapies with sex stratification in drug-related adverse events (ADRs). Ten-year data from adults with moderate-to-severe psoriasis requiring systemic treatment (conventional systemic therapies [CST], biologics) were obtained from the Swiss psoriasis registry (SDNTT). ADRs were categorized according to the international terminology Medical Dictionary for Regulatory Activities (MedDRA). Safety was assessed by calculating event rates per 100 patient-years (PY). We used descriptive statistics for patient and disease characteristics, and binomial and t-tests to compare treatment groups and sex. In total, 791 patients (290 females) were included with a mean age of 46 years. 358 (45%) received CSTs and 433 (55%) biologics; both groups had similar baseline characteristics except for more joint involvement in patients using biologics (26.86% vs. 14.8%, p < 0.0001). CSTs were associated with a 2.2-fold higher ADR rate (40.43/100 PY vs. 18.22/100 PY, p < 0.0001) and an 8.0-fold higher drug-related discontinuation rate than biologics (0.16/PY vs. 0.02/PY, p < 0.0001). Trends showed non-significant higher serious adverse event rates per 100 PY for biologics (8.19, CI 6.87-9.68) compared to CSTs (7.08, CI 5.39-9.13) (p = 0.3922). Sex stratification revealed a significantly higher overall ADR rate for all treatments in females (1.8-fold for CSTs [57.30/100 PY vs. 31.69/100 PY] and 2.0-fold for biologics [27.36/100 PY vs. 13.9/100 PY], p < 0.0001), and drug-related discontinuation rates for most CSTs in females. Females were associated with a significantly higher rate of ADRs and drug-related discontinuation rates. Sex stratification should be taken into consideration when designing studies in the patient-tailored management of psoriasis.

Neutrophil-to-Lymphocyte Ratio, Neutrophil-to-Monocyte Ratio, Platelet-to-Lymphocyte Ratio, and Systemic Immune-Inflammation Index in Psoriasis Patients: Response to Treatment with Biological Drugs.

Psoriasis is a chronic immune-mediated skin disease in which systemic inflammation plays an important role in its pathogenesis. In recent years, the neutrophil-to-lymphocyte ratio (NLR), neutrophil-to-monocyte ratio (NMR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII) were shown to be important indicators of inflammation. This study aimed to investigate the NLR, NMR, PLR, and SII levels in psoriasis patients treated with biological agents. Clinical and biochemical data of 209 patients who received systemic therapy for psoriasis were obtained by retrospectively reviewing their medical records. The NLR, NMR, PLR, and SII values were calculated from the hemogram values of the patients. In the third month of follow-up, the mean CRP, NLR, NMR, PLR, and SII values were significantly decreased compared with the baseline values. The SII values showed strong positive correlations with the NLR, NMR, and PLR. Adalimumab, etanercept, and infliximab, which are TNF-α blockers, were observed to be more effective on the PLR and NLR, and especially the NMR. The NLR, NMR, PLR, and SII, which are data derived from routine blood tests, can be used in the monitoring of the treatment of psoriasis, especially with TNF-α blockers.

Improvements in Skin and Nail Psoriasis are Positively Correlated across Systemic Psoriasis Therapies

Objective: For clinical scenarios where patients have moderate to severe psoriasis and nail psoriasis, knowing whether skin response is correlated with nail response would provide insight into the relationship between psoriatic skin and nail unit inflammation. The primary objective of this study was to determine if improvement in skin and nail psoriasis across a range of systemic therapies are correlated. Methods: Relevant publications pertaining to systemic therapies approved in the US for psoriasis were identified via PubMed search. Only studies with placebo controls were included. The paired point estimates of the PASI 75 response treatment effect [i.e., the placebo-adjusted PASI 75 response rate] (independent variable) and mean percentage NAPSI improvement for target fingernail treatment effect [also placebo-adjusted] (dependent variable) were calculated for each therapy. Simple linear regression analysis weighted by the standard errors for the independent and dependent variables was performed. Results: Ten paired treatment effects for 4 systemic therapies (apremilast, adalimumab, etanercept, and guselkumab) were obtained. Guselkumab and adalimumab were associated with the greatest nail improvement, and guselkumab was associated with the greatest skin response rate. PASI 75 response rate and mean percentage improvement target fingernail NAPSI were positively correlated (p=0.03), with an R2 value of 0.48. Conclusions: There is significant positive correlation across different therapies between the magnitude of improvement in psoriatic skin and nail disease among patients with moderate-severe psoriasis and clinically significant nail disease.

Psoriasis: A Primer for General Physicians.

Psoriasis is a multisystem, polygenic, inflammatory condition that typically causes changes in the skin. Although there is a significant genetic component, environmental factors like infections can have a significant impact on triggering the disease. A major part of the pathogenesis of psoriasis is played by the Interleukin (IL) IL23/IL17 axis along with the immune-related cells mainly macrophages and dendritic cells (DCs). Additionally, the role of various cytokines along with the toll-like receptors has also been pointed out in immunopathogenesis. These have been supported by the efficacy of biological therapies including TNF alpha inhibitors and inhibitors of IL17 and IL23. We have summarized the topical as well as systemic therapies for psoriasis including biologics. The article throws light on a few emerging therapeutic options like modulators of sphingosine 1-phosphate receptor 1 and Rho-associated kinase 2 inhibitors.

ASSESSMENT OF INFECTION RISK IN OLDER PATIENTS WITH PSORIASIS ON SYSTEMIC THERAPY

Systemic treatment for psoriasis can be effective but have more risk of infection especially in old age groups. The aim of this study is to assess the infection risk in older patients with psoriasis on systemic therapy. A total of 639 patients were included in the study those were taking systemic therapy for psoriasis for last 6 months. They were divided into two groups. Group A with younger patients whereas the Group B had the older patients. Data was gathered and analyzed. Both groups were compared with respect to the incidence of infection. The results showed that that the group B had significantly high frequency of infection compared to the Group A. In conclusion, the assessment of infection risk in older patients with psoriasis who are receiving systemic therapies is crucial to ensure that patients receive the most appropriate and effective treatment while minimizing the risk of infections and other adverse events.

Use of Systemic Therapies for Treatment of Psoriasis in Patients with a History of Treated Solid Tumours: Inference-Based Guidance from a Multidisciplinary Expert Panel.

Patients with treated solid tumours (TSTs) are a highly heterogeneous population at an increased risk for malignancy compared with the general population. When treating psoriasis in patients with a history of TSTs, clinicians are concerned about the immunosuppressive nature of psoriasis therapies, the possibility of augmenting cancer recurrence/progression, and infectious complications. No direct, high-level evidence exists to address these concerns. We aim to provide a structured framework supporting healthcare professional and patient discussions on the risks and benefits of systemic psoriasis therapy in patients with previously TSTs. Our goal was to address the clinically important question, "In patients with TSTs, does therapy with systemic agents used for psoriasis increase the risk of malignancy or malignancy recurrence?" We implemented an inference-based approach relying on indirect evidence when direct clinical trial and real-world data were absent. We reviewed indirect evidence supporting inferences on the status of immune function in patients with TSTs. Recommendations on systemic psoriasis therapies in patients with TSTs were derived using an inferential heuristic. We identified five indirect indicators of iatrogenic immunosuppression informed by largely independent bodies of evidence: (1) overall survival, (2) rate of malignancies with psoriasis and systemic psoriasis therapies, (3) rate of infections with psoriasis and systemic psoriasis therapies, (4) common disease biochemical pathways for solid tumours and systemic psoriasis therapies, and (5) solid organ transplant outcomes. On the basis of review of the totality of this data, we provided inference-based conclusions and ascribed level of support for each statement. Prior to considering new therapies for psoriasis, an understanding of cancer prognosis should be addressed. Patients with TSTs and a good cancer prognosis will have similar outcomes to non-TST patients when treated with systemic psoriasis therapies. For patients with TSTs and a poor cancer prognosis, the quality-of-life benefits of treating psoriasis may outweigh the theoretical risks.

Clinical case: switching from basic therapy with methotrexate to therapy with netakimab, an IL-17 inhibitor, in a patient with severe psoriasis

Currently, psoriasis occupies a leading position in the structure of chronic recurrent dermatological diseases. The modern view on the etiopathogenesis of psoriasis allows us to consider this disease as a systemic, genetically determined, immune-mediated process, which manifests itself not only in the form of damage to the skin, but also leads to the development of various comorbid conditions (lesion of the musculoskeletal system, cardiovascular system, excretory system , metabolic disorders, etc.). This fact radically changes the approach to the treatment of patients with psoriasis, to the selection of a systemic drug. The main points in the management of patients with psoriasis, especially of moderate and severe course: interdisciplinary examination of the patient, prevention of the development of comorbid conditions and irreversible (sometimes disabling) changes in internal organs and systems, timely administration of systemic therapy. The article presents modern aspects of the etiopathogenesis of psoriatic disease, the advantages of genetically engineered biological therapy, and a clinical case of treating a patient with severe psoriasis. A 48-old-patient E. who had been suffering from extensive psoriasis vulgaris for 16 years, which manifested after pregnancy and childbirth, was proscribed the systemic therapy. In July 2022, the patient reported oedema that developed in the lower extremities and face while taking methotrexate, and was examined by a nephrologist. Microalbuminuria nephropathy was diagnosed, which served as a reason for adjusting the systemic therapy for psoriasis. The patient had to be switched to the genetically engineered biological therapy. After 3 subcutaneous injections of netakimab at a dose of 120 mg/week, psoriasis went into a steady-state showing the trend towards a regressing stage. The psoriasis severity index scores decreased by the end of the initiating course of therapy.

COVID-19 and adherence to biologic therapies for psoriasis: An analysis of nationwide pharmacy claims data.

BACKGROUND: Early after the onset of the COVID-19 pandemic, concerns were raised that the use of psoriasis treatments, particularly biologic therapies because of their immunosuppressant effects, could be associated with a poor prognosis in the case of COVID-19 infection. OBJECTIVE: To examine changes in adherence to systematic biologic therapies for psoriasis after the onset of the COVID-19 pandemic. METHODS: Using IQVIA medical and pharmacy claims data from January 1, 2018, to October 31, 2020, we identified patients aged 18 years or older who had a diagnosis of plaque psoriasis in 2018 and who received systemic biologic therapies for psoriasis, including both provider-administered and pharmacy-dispensed therapies. We calculated the incidence of 14-day gaps without therapy per 1,000 study participants for each 30-day interval. We constructed interrupted time series analyses to test changes in the incidence of outcomes after the pandemic declaration. RESULTS: The sample included 15,890 study participants: 45.4% were female and 15.2% were aged 65 years or older. For patients using biologic therapies dispensed from the pharmacy, there was a 13.1% decrease in the incidence of 14-day gaps without biologic therapy immediately after pandemic declaration, from 92.4 gaps per 1,000 patients to 80.2 gaps per 1,000 patients, but this decrease was not statistically significant. However, for patients using provider-administered therapies, the incidence of 14-day gaps without biologic therapy increased by 55.1% after pandemic declaration, from 29.0 gaps per 1,000 patients to 44.9 gaps per 1,000 patients (P < 0.01). CONCLUSIONS: Following the onset of the COVID-19 pandemic, we found an increased incidence of gaps in biologic therapy for psoriasis among users of provider-administered treatments but not among users of pharmacy-dispensed therapies. DISCLOSURES: Dr Hernandez reports personal fees from Bristol Myers Squibb and personal fees from Pfizer outside the submitted work. Dr Hernandez is funded by the National Heart, Lung and Blood Institute (grant K01HL142847). The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The statements, findings, conclusions, views, and opinions expressed in this publication are based on data obtained under license from IQVIA as part of the IQVIA Institute's Human Data Science Research Collaborative.

Protein network and pathway analysis in a pharmacogenetic study of cyclosporine treatment response in Greek patients with psoriasis.

Although cyclosporine comprises a well-established systemic therapy for psoriasis, patients show important heterogeneity in their treatment response. The aim of our study was the pharmacogenetic analysis of 200 Greek patients with psoriasis based on the cyclosporine pathway related protein-protein interaction (PPI) network, reconstructed through the PICKLE meta-database. We genotyped 27 single nucleotide polymorphisms, mapped to 22 key protein nodes of the cyclosporine pathway, via the utilization of the iPLEX®GOLD panel of the MassARRAY® System. Single-SNP analyses showed statistically significant associations between CALM1 rs12885713 (P = 0.0108) and MALT1 rs2874116 (P = 0.0006) polymorphisms with positive response to cyclosporine therapy after correction for multiple comparisons, with the haplotype analyses further enhancing the predictive value of rs12885713 as a pharmacogenetic biomarker for cyclosporine therapy (P = 0.0173). Our findings have the potential to improve our prediction of cyclosporine efficacy and safety in psoriasis patients, as well as provide the framework for the pharmacogenetics of biological therapies in complex diseases.

33121 Do loading doses in systemic therapy for psoriasis improve clinical outcomes?

“Loading doses” are sometimes used to more rapidly achieve therapeutic drug levels and, in some cases, thought to improve the success rates of medications. We reviewed the literature for studies to examine the clinical impact of loading dose versus non–loading dose regimens in systemic therapy for psoriasis. We identified 254 studies examining clinical outcomes in systemic therapy for psoriasis, and, from these, we found 4 clinical trials and 1 retrospective observational study with data that could be used to compare the effect of loading dose versus non–loading dose regimens in adalimumab, etanercept, or secukinumab.

32102 Response in the placebo group in randomized controlled trials for moderate-to-severe psoriasis

Background: Using a placebo (PBO) as a comparator in randomized controlled trials (RCTs) evaluating new systemic therapies (STs) in plaque psoriasis is justified by disease fluctuation and PBO effect. The aim was to assess the PBO response and to identify factors associated with its variability.

Biological therapy of psoriasis in the era of COVID-19: discussing the risks and benefits

BACKGROUND: The new coronavirus infection COVID-19 in 2020 has spread widely around the world, including the Russian Federation. Risk factors for adverse outcomes of COVID-19, such as obesity, diabetes, chronic heart and kidney diseases, non-alcoholic fatty liver hepatosis, often accompany psoriasis, especially severe. Assessment and reduction of these risks have become an integral task of psoriasis therapy. An important issue was the use of immunosuppressive therapy in patients during the pandemic.&#x0D; AIMS: In this article, we tried to analyze the international experience of colleagues with a focus on psoriasis and correlate it with our own experience. To assess the impact of psoriasis, concomitant syndromes and applied biological and non-biological systemic therapy on the risk of infection and the nature of the course of COVID-19.&#x0D; MATERIALS AND METHODS: The analysis of available scientific publications on the effect of psoriasis, concomitant comorbidities and the therapy used on the incidence, nature of the course and outcomes of the new coronavirus infection COVID-19 was carried out. Data collection (questionnaire and analysis of available medical documentation on transferred COVID-19 cases and detection of antibodies) and a retrospective analysis of the history of COVID-19 disease in psoriasis patients in the Republic of Crimea who are on dispensary registration and receiving systemic (biological and targeted) therapy (n=146) were performed. The search for articles on the topic was carried out in the PubMed database in English and Russian, published in the period from 2019 to 2021.&#x0D; RESULTS: According to available literature data, systemic biological drugs from the group of interleukin inhibitors for the treatment of psoriasis did not worsen the course of COVID-19.&#x0D; Established a proactive anti-inflammatory effect for drugs from the group of IL-17 inhibitors.&#x0D; According to the latest version 14 of the recommendations for the treatment of COVID from 27.12.2021, the IL-17A inhibitor netakimab is included in the group of drugs of proactive anti-inflammatory therapy. Out of 146 patients with psoriasis receiving biological and targeted therapy, 8 patients underwent acute respiratory infections in 18 months, confirmed COVID-19 was established in 26 cases, antibodies were detected in 54 patients. Out of the patients with pneumonia and COVID-19, hospitalization for biological therapy was not required and only one case of hospitalization for therapy with apremilast (CT 1) was recorded. It should be noted that in the families of patients undergoing biological therapy, there were cases of COVID-19 (CT 23) and even a fatal outcome, however, no clinical manifestations of the disease were observed in our patients, and antibodies were detected during laboratory examination.&#x0D; CONCLUSIONS: To date, there is no convincing evidence that drugs for systemic therapy of psoriasis can worsen the course of COVID-19. A proactive anti-inflammatory effect was noted for drugs from the group of IL-17 inhibitors. The existing international and Russian recommendations on the management of patients on biological therapy in the COVID-19 pandemic reflect the current experience and views of the expert community, it is necessary to further accumulate new data and exchange clinical experience along with the evolution of the pandemic. Available vaccines against COVID-19 that are not live may be used with caution during immunosuppressive therapy.

Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis

Psoriasis is a chronic disease requiring long-term management; understanding the long-term safety profiles of psoriasis treatments, such as bimekizumab, is important. To evaluate the 2-year safety profile of bimekizumab in patients with moderate to severe plaque psoriasis. Safety data were pooled from a cohort of patients from 4 phase 2 randomized clinical trials (BE ABLE 1, BE ABLE 2, PS0016, and PS0018) and 4 phase 3 randomized clinical trials (BE VIVID, BE READY, BE SURE, and BE BRIGHT) to include 2 years of study treatment. Data were obtained on adults with moderate to severe plaque psoriasis (Psoriasis Area and Severity Index level ≥12, ≥10% body surface area affected by psoriasis, and an Investigator's Global Assessment score ≥3 on a 5-point scale) who were eligible for systemic psoriasis therapy and/or phototherapy. Included patients received 1 or more doses of bimekizumab during the phase 2 or phase 3 trials. Treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs leading to treatment discontinuation are reported using exposure-adjusted incidence rates (EAIRs) per 100 person-years. A total of 1789 patients (1252 [70.0%] men; mean [SD] age, 45.2 [13.5] years) were treated with 1 or more doses of bimekizumab across the phase 2/3 trials and were included in these analyses; total bimekizumab exposure was 3109.7 person-years. TEAEs occurred at an EAIR of 202.4 per 100 person-years and did not increase with longer duration of bimekizumab exposure. The 3 most frequently reported TEAEs were nasopharyngitis (19.1 per 100 person-years; 95% CI, 17.4-20.9 per 100 person-years), oral candidiasis (12.6 per 100 person-years; 95% CI, 11.3-14.0 per 100 person-years), and upper respiratory tract infection (8.9 per 100 person-years; 95% CI, 7.8-10.1 per 100 person-years). Most oral candidiasis events were mild or moderate; 3 events led to discontinuation. The EAIRs of inflammatory bowel disease (0.1 per 100 person-years; 95% CI, 0.0-0.3 per 100 person-years), adjudicated suicidal ideation and behavior (0.0 per 100 person-years; 95% CI, 0.0-0.2 per 100 person-years), and adjudicated major adverse cardiac events (0.5 per 100 person-years; 95% CI, 0.3-0.8 per 100 person-years) were low. In these pooled analyses of data from a cohort of patients from 8 randomized clinical trials, bimekizumab was well tolerated aside from an increased incidence of mild to moderate oral candidiasis. No safety signals were observed compared with previous reports, and there was no increased risk of AEs with longer duration of bimekizumab exposure.

Therapy of psoriasis during pregnancy and breast-feeding.

There have been multiple systemic drugs approved for the therapy of psoriasis vulgaris and psoriasis arthritis (PsA) in the last decade. However, treatment decisions are difficult to make in women planning a pregnancy and in pregnant and lactating women due to the paucity of data for such cases. The strongest evidence for psoriasis therapy during pregnancy exists for topical corticosteroids. Medically controlled use of UVB-therapy is also considered safe. The best evidence regarding systemic therapy during pregnancy and lactation is available for the group of TNF-alpha inhibitors, which is also reflected in the respective medical product information. This is especially important in cases of psoriatic arthritis. Among traditional systemic therapeutics, the largest clinical experience exists for ciclosporin, which, if medically necessary, may be continued during gestation. However, TNF-alpha inhibitors, especially the pegylated form, should be preferred in case of pregnancy. Furthermore, an elective pregnancy termination is not necessary due to systemic therapy of psoriasis with many further substances during the first pregnancy weeks. The current work provides a comprehensive review of the scientific literature on treatment of psoriasis during pregnancy and lactation. Based on the available scientific information, severity of psoriasis and patient's comorbidities, the best possible therapeutic approach can be found in consensus with the patient.