Conventional Systemic Drugs Research Articles

Comparison of safety profile in patients with atopic dermatitis treated with dupilumab or conventional systemic treatment: real world data from the US network

Background Safety of dupilumab in atopic dermatitis (AD) was investigated in randomized controlled trials (RCT). However, head-to-head trials comparing with conventional systemic drugs are lacking and large real-world data on the long-term safety profile as compared are scarce. Objective To compare long-term safety profile of dupilumab with conventional systemic drugs used in the management of moderate to severe AD. Methods Data from electronic health records of AD patients treated with either dupilumab, azathioprine, Cyclosporine A, mycophenolate mofetil, methotrexate, or oral glucocorticoids were retrieved from the TriNetX US Collaborative Network. Risks of adverse events and new onset of type-2-inflammatory diseases within 5 years after treatment initiation was investigated. Results 5 propensity-matched cohorts, up to 18,708 individuals per cohort, were created. Dupilumab treatment displayed reduced risk for diseases of the circulatory, the upper respiratory, and the musculoskeletal system, infections, and type 2 diseases as compared to all other treatment options. In contrast risk for conjunctivitis was increased in dupilumab treated patients as compared to mycophenolate mofetil and methotrexate. Conclusion Here presented data indicates that treatment with dupilumab for AD has reduced risk for adverse effects of conventional systemic drugs and thus might be safer. Obtained data should be verified in prospective studies.

A Non-Interventional, Multicenter Study to Characterize the Socio-Demographics, Clinical Characteristics, and Management of Generalized Pustular Psoriasis Patients in Spain: IMPULSE Study.

Generalized pustular psoriasis (GPP) is a chronic, rare, and potentially life-threatening skin condition characterized by flares comprising widespread sterile pustules and systemic inflammation. Both the rarity and heterogeneity of the disease have made GPP classification and standardization of clinical criteria challenging. Before the approval of spesolimab (IL-36R antibody) in 2022, there were no approved treatments in the USA or Europe for GPP flares. Treatment for GPP has amounted to off-label use of medicines approved to treat plaque psoriasis. Our aim was to describe the sociodemographics, clinical characteristics, and treatment patterns of patients with GPP in Spain. Non-interventional, descriptive, multi-center, retrospective chart review of patients diagnosed with GPP in Spain. 56 patients (50% women) were included, with a mean (standard deviation, SD) age at diagnosis of 53.7 (20.5) and a mean (SD) time of follow-up of 3.7 (3.1) years. In 80% of patients, GPP diagnosis was associated with a flare and 67.3% had known risk factors for GPP (such as previous diagnosis or family history of plaque psoriasis, comorbidities, smoking or stress). Hypertension and plaque psoriasis were the most frequent comorbidities (44.6% each). The number of GPP flares per patient-year was 0.55 with (range 0-4) a mean (SD) body surface area involvement of 21.3% (19.1). The most frequent manifestations of GPP flares were pustules (88.5%), erythema (76.9%), and scaling (76.9%). Additionally, 65.4% of patients had plaque psoriasis, 53.8% had unspecified skin lesions, and 30.8% experienced pain. The treatments used for GPP flares were off-label conventional systemic drugs (75%), mostly corticosteroids, cyclosporine, and acitretin. In the periods between flares, off-label biologics were used in 56.5% of patients. During the study period, 9 patients (16.1%) had at least one complication and 5 of them required hospitalization. This is the first multicenter study in Spanish GPP patients. Most patients were in their fifties, with personal or family history of plaque psoriasis, stress, smoking and a wide range of comorbidities and complications. Even though the number of flares per patient/year was 0.55, there was variability between patients. Both off-label conventional systemics and off-label biologics were used for flare management without a clear treatment pattern.

Management of Psoriasis Patients with Serious Infectious Diseases.

The management of patients affected by moderate-to-severe psoriasis may be challenging, in particular in patients with serious infectious diseases [tuberculosis (TB), hepatitis B and C, HIV, COVID-19]. Indeed, these infections should be ruled out before starting and during systemic treatment for psoriasis. Currently, four conventional systemic drugs (methotrexate, dimethyl fumarate, acitretin, cyclosporine), four classes of biologics (anti-tumour necrosis factor alpha, anti-interleukin (IL)12/23, anti-IL-17s, and anti-IL-23], and two oral small molecules (apremilast, deucravacitinib) have been licensed for the treatment of moderate-to-severe psoriasis. Each of these drugs is characterized by a unique safety profile which should be considered before starting therapy. Indeed, some comorbidities or risk factors may limit their use. In this context, the aim of this manuscript was to evaluate the management of patients affected by moderate-to-severe psoriasis with serious infectious diseases.

Nail Psoriasis: An Updated Review of Currently Available Systemic Treatments.

Nail psoriasis (NP) has a prevalence that ranges from 10 to 82% among patients with psoriasis (PsO) and is one of the most common difficult to treat site of psoriasis. We performed a thorough review of the literature, exploring evidence regarding all available NP systemic treatments, describing also in detail NP dedicated clinical trials. A literature search was conducted in PubMed and Embase prior to February 2023 using a combination of the terms "nail" AND "psoriasis" AND "systemic therapy" AND/OR "systemic treatment". A total of 47 original studies and case reports were reviewed in this article. Systemic therapies should be considered when the disorder involves more than 3 nails, has extensive skin and joint involvement, and has a significant impact on QoL, due to their best long-term efficacy. In detail, conventional and biologic systemic drugs demonstrated efficacy in recent trials, including acitretin, methotrexate, cyclosporine, apremilast, adalimumab, infliximab, etanercept, certolizumab, golimumab, ustekinumab, secukinumab, ixekizumab, brodalumab, bimekizumab, guselkumab, risankizumab and tildrakizumab. Several therapies have demonstrated efficacy and safety in the treatment of NP; however, the choice of treatment depends not only on the severity of the nail involvement, but also on whether PsA is present, the patient's comorbidities other than PsA, previous treatment history, and the patient's drug preferences.

PS09 The raising of Lazarus: re-engagement of adults with atopic dermatitis following the advent of novel effective therapies

Abstract Atopic dermatitis (AD) has a devastating impact on quality of life, and persistent AD affects at least 7% of adults. Until recently, options for severe AD beyond topical therapies were limited to phototherapy and conventional immunosuppressive systemic drugs. With the advent of highly effective targeted treatments such as dupilumab and Janus kinase inhibitors (JAKi), patients with AD who had been lost to follow-up in dermatology are now returning en masse for consideration of biologic treatment or JAKi. The aim of this study was to analyse qualitatively the recapture of adults with severe AD who had previously been lost to follow-up because of disillusionment with suboptimal therapies and care. Semi-structured interviews were performed with 12 adults with severe AD to discuss their pathway to return to dermatology. Thematic analysis divided concepts into two categories: experiences of losing contact with dermatology and experiences of re-engagement with dermatology. Themes related to leaving dermatology care included the ineffectiveness of older treatments, toxicity of older treatments, attendance futility, dermatologist fatigue and ‘fizzling out’. ‘The ciclosporin would work for a few weeks but then I would have a flare, and my kidneys nearly gave out’; ‘I could tell the dermatologist was sick of looking at me. Back then I thought I was the problem, but now I think he was embarrassed because he couldn’t help me’; ‘I never decided I was going to stop going, it just ended up fizzling out and never going back.’ Themes related to re-engaging with dermatology care included social media influence, novelty, exasperation with quality of life and the life-changing improvements seen with novel treatments. ‘I saw someone on Facebook showing pictures after a few weeks on the injection and I went straight to my GP for a referral back to the dermatologist’; ‘After 60 years with eczema I just wanted to try something new, even if it killed me!’; ‘A few days after starting the tablets I left like Lazarus, it was like standing up out of a wheelchair for the first time in my life.’ This study highlights the reasons why adults with AD left dermatology services, explains why they re-engaged and deeply explores the transformative effect that novel treatments have had on the AD landscape. As adults with AD continue to return to dermatology care, the implications of increasing patient numbers needing biologic and JAKi therapy should be factored into healthcare and finance planning.

Cost analysis in the management of moderate-to-severe psoriasis: comparison between conventional and biological systemic therapies.

Background. Psoriasis is a chronic inflammatory skin disease with an important socio-economic burden. Available therapies include conventional systemic drugs and biological drugs, such as Tumor Necrosis Factor (TNF)-α inhibitors, that are characterized by high costs. Aim. Perform a cost-estimation analysis of conventional treatment vs therapy with biosimilar TNF-α inhibitor between January 2021 and January 2022, according to the Apulia regional cost list. Methods. The average annual expenditure per patient on conventional treatment (cyclosporine and methotrexate) vs therapy with biosimilar TNF-α inhibitor was compared. The 'cost per responder' was determined by analyzing the percentages of 'responders' (patients achieving PASI 75 and PASI 90) and 'non-responders' (PASI <75) after one year of treatment. Results. The annual per capita expenditure with cyclosporin was €3,515.35, with methotrexate was €1,048.87, while for treatment with TNF-α biosimilar inhibitor drug was €3,030.11. The "cost per responder" analysis showed a value of €8,573 for cyclosporine, €2,834 for methotrexate, and €3,564 for TNF-α biosimilar inhibitor. Conclusions. Conventional drugs have a greater impact on healthcare expenditure than TNF-α biosimilar inhibitors.

Association between psoriasis, sleep, and dermatological quality of life: results of a cross-sectional study.

Psoriasis is a chronic relapsing inflammatory T-cell mediated disease who affects patients' daily activities and life quality. The association between sleep quality, dermatological quality of life (QoL) and psoriasis severity has been poorly investigated to date. The aim of this study is to investigate how sleep quality impacts on the severity of psoriasis, and to assess whether the different therapies used for psoriasis affect the dermatological QoL. We conducted a cross-sectional study on 152 adult patients based on specific questionnaires about the sleep quality (PSQI) and the dermatological quality of life (DLQI). Patients were divides into three groups according to severity (mild, moderate and severe) and therapy (group 1: no current therapy or exclusive use of topical drugs, group 2: use of conventional systemic drugs and group 3: biologics). The outcomes were expressed in the form of an Odd Ratio (OR) and for each variable it was commented whether the OR obtained was statistically significant or not. Inferential statistics comparing patients' DLQI showed that patients in group 3 and group 1 had comparable results. The OR obtained allowed us to state that those not taking biological drugs have a 4-fold higher risk of developing severe psoriasis than those taking them as therapy. No statistical difference was highlighted about sleep quality. This emphasizes that adequate therapy with biologic drugs allows patients with severe psoriasis to have a comparable QoL to those who are not impaired enough to require systemic or biologic therapy.

A Challenging Case of Recalcitrant Hyper-IgE Syndrome Successfully Treated with Omalizumab

Abstract Hyper-IgE syndrome (HIES) is a rare group of primary immunodeficiency diseases characterized by elevated IgE levels, eosinophilia, recurrent pyoderma, ear infection, eczematous dermatitis, and pulmonary infection. The treatment depends on the clinical presentation of the disease. The eczematous skin lesions usually respond to a topical steroid, calcineurin inhibitors, and sometimes, based on severity, systemic drugs are given. The secondary infections are usually treated with oral and topical antibiotics. We are describing a case of HIES who presented with severe recalcitrant itchy oozy eczematous skin lesions which did not respond to conventional systemic drugs and were later on controlled with injection omalizumab. In addition, we have discussed the HIES in detail in the current article.

Towards Personalized Medicine in Psoriasis: Current Progress.

Although innovative targeted therapies have positively revolutionized psoriasis treatment shifting treatment goals to complete or almost complete skin clearance, primary or secondary lack of efficacy is still possible. Hence, identifying robust biomarkers that reflect the various clinical psoriasis phenotypes would allow stratify patients in subgroups or endotypes, and tailor treatments according to the characteristics of each individual (precision medicine). To sum up the current progress in personalized medicine for psoriasis, we performed a review on the available evidence on biomarkers predictive of response to psoriasis treatments, with focus on phototherapy and systemic agents. Relevant literature published in English was searched for using the following databases from the last five years up to March 20, 2022: PubMed, Embase, Google Scholar, EBSCO, MEDLINE, and the Cochrane library. Currently, more evidence exists towards biologicals, as justified by the huge health care costs as compared to phototherapy or conventional systemic drugs. Among them, most of the studies focused on anti-TNF and IL12/23, with still few on IL17 (mainly secukinumab). The most discussed biomarker gene is the HLA-C*02:06 status that has been shown to be associated with psoriasis, and also differential response to biologicals. Although its positivity is associated with great response to MTX, debatable results were retrieved concerning both anti-TNF and IL12/23 while it seems not to affect secukinumab response. Personalized treatment in psoriasis would provide excellent outcome minimizing the risk of side effects. To date, although several candidates were proposed and assessed, the scarcity and heterogeneity of the results do not allow the identification of the gold-standard biomarker per each treatment. Anyway, the creation of a more comprehensive panel would be more reliable for the treatment decision process.

Translated article] Implementation of Recommendations for the Management of Psoriasis During Preconception, Pregnancy, Postpartum, Breastfeeding, and Perinatal Care

ObjectiveTo analyze degree of implementation of recommendations on the management of psoriasis during preconception, pregnancy, postpartum, breastfeeding, and perinatal care published by the Psoriasis Working Group of the Spanish Academy of Dermatology and Venereology (AEDV). MethodsWe designed a structured online survey consisting of closed questions. A link was emailed to all the members of the Psoriasis Working Group to collect their anonymous responses. We also collected sociodemographic, professional, and practice-related data related to the goals of the study and then compiled descriptive statistics to analyze the survey findings. ResultsWe received 53 responses for analysis. Overall, 96% of respondents were familiar with the recommendations, but very few of them worked in multidisciplinary maternity care units or had access to specific protocols on the management of psoriasis before, during, and after pregnancy in their departments. Seventy percent of dermatologists regularly ask their patients about pregnancy plans, but only 46% ask both men and women. Women also receive more preconception advice than men (54% vs. 19%). Significant variations were observed in the type of advice given. Ninety percent of the dermatologists interrupt topical treatments during pregnancy, and nearly all suspend conventional systemic drugs with the exception of cyclosporin A. Most biologics are also being discontinued in the third trimester, with the exception of certolizumab pegol. Almost all the respondents indicated that they use topical treatments, phototherapy, and certolizumab pegol in breastfeeding mothers. The main barriers to implementing the working group's recommendations are a lack of time, a lack of support, and a lack of robust data. ConclusionsAlthough the AEDV psoriasis working group's recommendations are widely known, areas for improvement remain.

Adalimumab Biosimilar Efficacy and Safety in a 5-Year-Old Patient with Severe Plaque Psoriasis During SARS-CoV-2 Pandemic Outbreak

BACKGROUND: Psoriasis is a chronic inflammatory disease that affects 2% of population. About 0.5–2% of psoriatic cases develop during pediatric age. In most cases, the condition is responsive to topical treatment. However, a small percentage of children require systemic treatment with conventional systemic drugs or biological agents, such as anti-tumor necrosis factor (TNF)-α. Adalimumab (ADA) is an anti-TNF-α recently approved for pediatric psoriasis in the European Union (from 4 years of age, 2015). CASE PRESENTATION: We describe our experience treating a 5-year-old female patient affected by severe plaque psoriasis with ADA biosimilar during SARS-CoV-2 pandemic outbreak also using teledermatology. CONCLUSION: The case reported in this article highlights the safety and the effectiveness of ADA biosimilar MSB11022 (Idacio®) in the treatment of a 5-year-old female affected by plaque psoriasis and paves the way to bigger trials for a more extensive use of TNF-α inhibitor biosimilars for psoriasis in pediatric population.

Implementación de las recomendaciones sobre las actuaciones a seguir durante la edad fértil, el embarazo, el posparto, la lactancia y el cuidado perinatal en pacientes con psoriasis

ObjectiveTo analyze degree of implementation of recommendations on the management of psoriasis during preconception, pregnancy, postpartum, breastfeeding, and perinatal care published by the Psoriasis Working Group of the Spanish Academy of Dermatology and Venereology (AEDV). MethodsWe designed a structured online survey consisting of closed questions. A link was emailed to all the members of the Psoriasis Working Group to collect their anonymous responses. We also collected sociodemographic, professional, and practice-related data related to the goals of the study and then compiled descriptive statistics to analyze the survey findings. ResultsWe received 53 responses for analysis. Overall, 96% of respondents were familiar with the recommendations, but very few of them worked in multidisciplinary maternity care units or had access to specific protocols on the management of psoriasis before, during, and after pregnancy in their departments. Seventy percent of dermatologists regularly ask their patients about pregnancy plans, but only 46% ask both men and women. Women also receive more preconception advice than men (54% vs. 19%). Significant variations were observed in the type of advice given. Ninety percent of the dermatologists interrupt topical treatments during pregnancy, and nearly all suspend conventional systemic drugs with the exception of cyclosporin A. Most biologics are also being discontinued in the third trimester, with the exception of certolizumab pegol. Almost all the respondents indicated that they use topical treatments, phototherapy, and certolizumab pegol in breastfeeding mothers. The main barriers to implementing the working group's recommendations are a lack of time, a lack of support, and a lack of robust data. ConclusionsAlthough the AEDV psoriasis working group's recommendations are widely known, areas for improvement remain.

Reaching Treatment Goals in Psoriasis with Conventional Systemic Drugs: How Long Are We Willing to Wait?

Objectives: The purpose of this study was to investigate the attainment of treatment goals according to the European Consensus Programme (ECP-TGs) from 2011 in patients with moderate to severe psoriasis (Pso) treated with the first conventional systemic therapy and to identify factors that might compromise the attainment of these treatment goals. Methods: In a multicenter, prospective observational study, patients with moderate to severe Pso, defined as either body surface area (BSA) >10% or psoriasis area severity index (PASI) >10 and dermatology life quality index (DLQI) >10, received a conventional systemic therapy that could be modified at each follow-up visit over the course of 18 months. All subjects signed an informed consent form, were ≥18 years of age as well as systemic therapy naïve, and had regular study visits at months 3, 6, 9, 12, and 18 after baseline. Among others and in addition to demographic and disease-related characteristics at baseline, we documented BSA, PASI, DLQI, and the physician-reported attainment of treatment goals at each follow-up visit. Factors related to a failure in achieving the ECP-TGs (i.e., either Δ PASI ≥75 or Δ PASI ≥50 and <75 with a DLQI ≤5) at month 18 were investigated by multiple logistic regression. Descriptive results are presented as the mean ± SD for interval data, and absolute as well as relative frequencies for nominal data. For this part of the analysis, data at baseline and months 6, 12, and 18 are presented. Results: A total of 133 Pso patients with a mean age and disease duration of 49.5 ± 14.4 and 15.6 ± 12.8 years, respectively, were included in the analysis; 54.1% (n = 72) were male. The mean baseline disease-related outcomes were: BSA: 21.5 ± 15.8%, PASI: 13.7 ± 7.14, and DLQI: 12.0 ± 6.11. The most common conventional systemic therapies initiated at baseline were fumaric acid esters (n = 74, 55.6%), methotrexate (n = 46, 34,6%), and ciclosporin (n = 6, 4.5%). The ECP-TGs were achieved by 58 patients (43.6%) at month 6, 86 patients (64.7%) at month 12, and 97 patients (72.9%) at month 18. An optimized reduced logistic regression model identified the presence of onycholysis/nail dystrophy at two or more digits to be associated with failing to attain the ECP-TGs (OR 10.7, 95% CI 2.5–46.7, p = 0.002). Conclusion: Patients with onycholysis/nail dystrophy at two or more digits were identified as having a higher risk of not achieving ECP-TGs under conventional systemic therapy. The ECP-TGs from 2011 were attained by 43.6% of our patients 6 months after starting conventional systemic therapies. In the era of safe, fast, and efficacious Pso therapies, much higher treatment goals might be achieved during therapy. New treatment goals are only of use if patients and dermatologists strive to attain them.

Apremilast: A new hope in psoriasis

Introduction: Psoriasis is a common, chronic, inflammatory skin disease that can have a significant impact on the quality of life of those who are afflicted due to chronicity of the disease and frequent remissions and relapse. There is a vast array of drugs for the treatment. Methotrexate, cyclosporine and retinoids are the most commonly used conventional systemic drugs. Newer studies provide insight into their more effective and safer use and as combination therapy with biologics. Apremilast is an orally administered, small molecule inhibitor of phosphodiesterase 4 (PDE4). Apremilast 30 mg twice daily reduced the severity of moderate to severe plaque psoriasis, palmoplantar psoriasis and guttate psoriasis. Objective: To evaluate efficacy, tolerability and adverse effects of apremilast. Materials and Methods: A clinical trail was conducted in department of Skin & VD of Saraswathi institute of medical college on 80 patients. Apremilast was started after initial titration and followed for 8 weeks. Results: Out of 80 patients 73 patients completed the study of which 69% patients have responded well and 14% patient did not show satisfactory result. No major side effect encountered during the study. Conclusion: Apremilast was effective in plaque psoriasis, palmo plantar psoriasis and guttate psoriasis and is well tolerated with mild adverse effects. Also the regular lab investigations as required in others systemic treatment modalities are avoided. Keywords: Apremilast, Plaque psoriasis, Phosphodiesterase 4 (PDE4), Guttate psoriasis, Palmo plantar psoriasis.

PBI15 The Economic Burden for the Management of Moderate-to-Severe Psoriasis in the Kingdom of Saudi Arabia

Psoriasis is a chronic, immune-mediated disease of the skin and joints, with a global prevalence of 2-3%. Treatment options include topical treatment, phototherapy, conventional systemic drugs, and biologics. Psoriasis Area and Severity Index (PASI) 75 is accepted as a reasonable response to therapy. However, with advent of PASI90 being potentially achievable, data demonstrating relevant value associated with achieving PASI90 compared to PASI75 are indispensable. Objective: to estimate the economic burden of managing moderate-to-severe psoriatic patients in the Kingdom of Saudi Arabia (KSA) who achieve a clinical outcome of PASI75 and assess the cost-utility of achieving PASI90 using Risankizumab. A Markov-model was developed with a 12-week cycle length and 40-year time horizon from a healthcare payer perspective. Costs considered were drug acquisition, drug administration, medical resources use, adverse events management, and travel costs. The model compared the current treatment sequence Anti-TNF-alpha (Adalimumab), IL12/23 inhibitors (Ustekinumab), and IL-17A inhibitor (Secukinumab), as 1st, 2nd, and 3rd line, respectively; targeting PASI75 versus IL-23 inhibitor (Risankizumab) as 1st line treatment option, targeting PASI90. Using the current treatment sequence and targeting PASI75 as a clinical outcome, the overall estimated cost of moderate-to-severe psoriasis management in KSA was USD 8.9 billion yielding 0.92 million (quality-adjusted life year) QALYs. The use of Risankizumab as 1st line option targeting PASI90 yielded an overall cost of USD 8.5 billion and 0.95 million QALYs. The cost-savings were attributed to the lower healthcare resource utilization while using Risankizumab. The increase in QALY gained was related to the increased probability of achieving PASI90 while using Risankizumab (72.2%). Targeting PASI90 using Risankizumab as a 1st line treatment option for moderate-to-severe psoriasis patients’ was not only found dominant versus the current treatment options, yielding higher QALYs eventually at lower costs; but may also improve quality of life without additional cost.

Epidemiology of moderate-to-severe psoriasis: a comparison between psoriasis patients treated with biological agents, conventional systemic drugs and topical agents

Introduction Understanding how different comorbidities and epidemiological factors are related to psoriasis severity can help us estimating patients’ clinical outcome. Aim Establish possible prognostic factors of severe psoriasis. Methods Three groups of patients were included: 118 were on topical therapy, 83 used conventional systemic drugs, and 112 were treated with biological agents. Based on the fact that patients on topical therapy have a lower grade of disease severity than patients treated systemically, we compared a variety of comorbidities and epidemiological parameters between the three groups. Results Patients treated more aggressively have an increased risk of cardiovascular disease (p = .044), suffer more from depression (p = .020), hyperuricemia (p = .031) and nonspecific noninfectious liver disease (p = .005). Male gender (p < .001), increased height (p < .001), early age of disease onset (p < .001), viral upper respiratory infections (p = .049) and periods of hormonal changes (p = .045) are associated with these therapies. Conclusion Psoriasis severity is directly related to an increased risk of cardiovascular disease, depression, hyperuricemia and nonspecific noninfectious liver disease. Male gender, increased height, early age of disease onset, viral upper respiratory infections and periods of hormonal changes seem to be prognostic of higher degrees of psoriasis severity. We are pioneering the use of increased height and puberty, menopause/andropause as independent prognostic factors of psoriasis severity.

Baricitinib: therapeutic potential for moderate to severe atopic dermatitis

ABSTRACT Introduction Atopic dermatitis (AD) is a chronic inflammatory skin disease mediated by multiple signals including janus kinase (JAK)/signal transducer and activator of transcription (STAT) pathway. Current therapeutic armamentarium consists of a limited number of drugs which may result in the insufficient management of AD. Preclinical evidence regarding inhibition of JAK/STAT led to the development of a promising class of therapeutics, namely, JAK inhibitors. Baricitinib, a novel JAK1/JAK2 inhibitor is currently under investigation in AD clinical trials. Areas covered This review offers an overview of Baricitinib and examines clinical efficacy and safety data in patients with moderate-to-severe AD. Expert opinion Baricitinib showed promising preliminary data in terms of efficacy in phase II and III trials, with a very rapid onset of response and great improvements of itch and sleep disturbances. These aforementioned aspects combined with the advantage of an oral formulation have reduced drug production costs compared to biologic agents and could lead to consideration of baricitinib as a first line systemic treatment. Also, in some countries, it could be a therapeutic option in the case of contraindication or failure of conventional systemic drugs prior to biologic therapies. Data related to long-term safety and efficacy will be important to refine the place-in-therapy of this drug.

Drug discontinuation in pregnant women with psoriasis: The PSO‐MOTHER cohort study

To analyse the drug use pattern in women with psoriasis before, during and after pregnancy. All children born (2009-2016) in a central Italian region (Lazio) to mothers with a diagnosis of psoriasis were identified. Drug use patterns (biologicals, systemic, and topical), and discontinuation and switching of drug therapies before, during, and after pregnancy were studied. Findings were compared with data from a population exposed to similar drug therapies (eg, antirheumatic drugs). Among 3499 deliveries by women affected by psoriasis, 1876 (53.6%) were diagnosed with this condition before the Last Menstrual Period (LMP). Of these, 525 (27.9%) had at least one drug prescription for psoriasis therapy during 6 months before LMP. For each class of drugs considered, there was a general decrease in its use during pregnancy. Considering the two trimesters preceding LMP and the three trimesters of pregnancy, the following percentages of prescriptions were observed: from 10.5% to 0% for biologicals, 7.2% to 2.5% for the conventional systemic drugs, and 51.1% to 9.4% for the topical treatments. After delivery, previous treatments were resumed. Similar results were observed for rheumatoid arthritis, a chronic condition. Majority of drugs come with warnings regarding potential embryo-fetotoxicity, which might play a role in the decision to continue treatments during pregnancy. According to our study pregnancy appears to have a significant influence on drug prescriptions of different pharmacological treatments for psoriasis.

Prescriptions hors AMM (autorisation de mise sur le marché) dans le psoriasis de l’enfant

Psoriasis affects 0.5% of children in Europe, with moderate to severe clinical forms in 15-35% of cases warranting the use of systemic treatments. Few treatments are licensed for childhood psoriasis. In this study, we analyzed the frequency of such prescriptions. Our study was based on 3retrospective cohort trials conducted in France between 2012and 2018: χ-Psocar (313children with psoriasis seen in hospitals), PsoLib (207children seen in a private practice), and BiPe (134children on biotherapies). Our evaluation was centered on off-label use. To avoid duplicates between cohorts, analysis focused on each cohort independently. In the χ-Psocar study, in 34.8% of cases, use of at least one off-label treatment, mainly topical vitamin D (36.0%), and systemic treatments (methotrexate and cyclosporine) was noted, on account of either the clinical type of psoriasis (13.7%) or patient age (24.6%). In the PsoLib study, in 41.5% of cases, at least one off-label treatment was noted, mainly combined calcipotriol-betamethasone (24.2%), ciclopirox shampoo (7.2%) and systemic treatments (n=20). The main reason was patient age (41.5%). In the BiPe study, in 97.0% of cases, at least one off-label treatment was noted. These prescriptions mainly concerned a combination of calcipotriol-betamethasone (68.7%) and tacrolimus (11.2%) along with systemic treatment comprising methotrexate, cyclosporin, methoxsalen or apremilast (n=125), but also biotherapies (n=85). The biotherapies were used off-label since at that time they had not yet been granted marketing authorisation. This study focused on 3cohorts of children with psoriasis seen either in private practice or in a hospital setting, and it involved all types of treatment. Off-label prescriptions ranged from one-third to almost 100% of the children, depending on the individual cohorts. The prescribed drugs were topical treatments, conventional systemic drugs and biotherapies. Off-label prescription is not strictly prohibited in France provided it is within a well-defined regulatory framework. Where there is a rich bibliography, confident recommendations may be made. Unfortunately, in childhood psoriasis, the literature and recommendations are very limited, leaving prescribers with considerable individual responsibilities. Review of the license concerning children with psoriasis, a push to conduct therapeutic studies and the drafting of recommendations all appear necessary.

Safety and effectiveness of conventional systemic therapy and biological drugs in patients with moderate to severe psoriasis and HIV infection: a retrospective multicenter study

Background: The management of HIV-positive patients with psoriasis is controversial and limited to individual cases or short series of patients.Objectives: To evaluate the safety and effectiveness of conventional and biologic immunosuppressive drugs in the treatment of patients with psoriasis and concomitant HIV infection.Methods: A retrospective multicenter study was conducted. The study included data from 2008 to 2016. Inclusion criteria were: HIV adult patients with moderate-to-severe psoriasis, HIV viral load determinations at baseline and at least after 6 months of treatment, and systemic immunosuppressive treatment for at least 6 months. A descriptive analysis was performed.Results: Twenty-three patients with plaque-type psoriasis and HIV infection (five with AIDS) were included. Median follow-up time was 3.2 years. The main drugs used were etanercept, methotrexate, and ustekinumab. In most cases, viral load and CD4 cell count not only remained stable but also improved throughout the follow-up. Six patients presented severe adverse events during the follow-up, four of them in the AIDS stage. At the end of the follow-up period, 76.5% of the patients had achieved a PASI 75.Conclusion: Biologic drugs, both anti-TNF alpha agents and ustekinumab, seem to have an acceptable safety profile and high effectiveness in HIV-positive patients.