Prevalence of HPV genital infection in patients with moderate-to-severe psoriasis undergoing systemic treatment with immunosuppressive agents or biologics.

Psoriasis is an immune-mediated inflammatory disease and its relationship with infection has been extensively investigated. Concern for the increased prevalence of human papilloma virus (HPV) infection in patients undergoing systemic immunomodulatory or immunosuppressive therapies for psoriasis has been gradually growing among clinicians. To evaluate the prevalence of HPV in a cohort of patients with psoriasis treated with currently available systemic, conventional and biotechnological drugs. A multi-centric prospective study was conducted in the main dermatological clinical centres of central and southern Italy. Data from 588 patients (366 males and 222 females) with moderate-to-severe psoriasis, aged ≥18 years and treated with conventional and biological drugs, were collected based on a documented history of HPV infection, a positive Papanicolaou test (Pap-test) when available, and clinical evidence of genital warts reported during consultation. Overall, 18 of 588 patients (3.6% [95% CI: 1.8-4.5]) were positive for HPV or had a history of cervical cancer. Considering anamnestic and demographic data, such as gender, age, smoking, weight and body mass index, no statistically significant differences between HPV+ and HPV- patients were found. Moreover, the eradication of HPV infection was successfully achieved using conventional treatments. The prevalence of HPV infection in patients with moderate-to-severe psoriasis, undergoing systemic treatment with immunosuppressive agents or biologics, appears to be the same as that in the general Italian population, indicating that the level of infection among such patients is acceptable.

HLA-Cw6 and other HLA-C alleles, as well as MICB-DT, DDX58, and TYK2 genetic variants associate with optimal response to anti-IL-17A treatment in patients with psoriasis.

Objective: Our pharmacogenomic study evaluated the influence of the presence/absence of genetic variants of psoriasis-risk loci on the clinical response to secukinumab. Differences in the single-nucleotide polymorphism (SNP) pattern characterizing HLA-Cw6+ or HLA-Cw6- patient subpopulations, showing high or low responses to secukinumab, were also analyzed. Methods: 417 SNPs were analyzed by Next-Generation Sequencing technology, in a cohort of 62 psoriatic patients and undergone secukinumab treatment. Univariate regression analysis was employed to examine the association between SNP and clinical response to secukinumab. Multivariate analysis was also performed to assess multivariate differences in SNP pattern of HLA-Cw6+ or HLA-Cw6- patients showing high or low responses to secukinumab. Results: Eight SNPs in HLA-C and upstream region (rs13207315, rs6900444, rs12189871, rs12191877, rs4406273, and rs10484554), including HLA-Cw6 classical allele (rs1131118), and three in MICB-DT (rs9267325), DDX58 (rs34085293) and TYK2 (rs2304255) genes, associating with excellent response to secukinumab were identified. Importantly, rs34085293 or rs2304255 SNP status defined a subgroup of super-responder patients. We also found that HLA-Cw6+ and HLA-Cw6- patients carried out specific patterns of SNPs associating with different responses to secukinumab. Conclusion: Assessment of HLA-Cw6, together with other allelic variants of genes, could be helpful to define patients which better benefit from anti-IL-17 therapy. Abbreviations: PASI: Psoriasis Area and Severity Index; SNP: Single-Nucleotide Polymorphism Rs: Reference SNP; PASI75: 75% reduction in Psoriasis Area and Severity Index; PASI90: 90% reduction in Psoriasis Area and Severity Index; PASI100: 100% reduction in Psoriasis Area and Severity Index; NGS: Next-Generation Sequencing; OR: Odds Ratio; CAP: Canonical Analysis of Principal coordinates; BMI: Body Mass Index; LD: Linkage Disequilibrium.

Characteristic of chronic plaque psoriasis patients treated with biologics in Italy during the COVID-19 Pandemic: Risk analysis from the PSO-BIO-COVID observational study.

Background: The susceptibility of patients with chronic plaque psoriasis and the risks or benefits related to the use of biological therapies for COVID-19 are unknown. Few data about prevalence, clinical course and outcomes of COVID-19 among psoriatic patients were reported. The aims of this study were 1) to assess the prevalence and severity of COVID-19 in psoriatic patients treated with biologic agents during the first phase of the emergency (22 February to 22 April 2020) in Italy, and 2) to report the clinical outcomes of patients who have been exposed to individuals with confirmed SARS-CoV-2 infection. Methods: Patients with moderate-to-severe chronic plaque psoriasis, aged ≥18 years and undergoing treatment with biologic agents as of 22 February 2020, were eligible to be included in PSO-BIO-COVID study. Demographic and clinical characteristics of patients using any biologic for psoriasis treatment between 22 February and 22 April 2020 were registered. Results: A total of 12,807 psoriatic patients were included in the PSO-BIO-COVID study. In this cohort 26 patients (0.2%) had a swab confirmation of SARS-CoV-2 infection. Eleven patients required hospitalization and two died. Conclusion: The incidence of COVID-19 observed in our cohort of psoriatic patients (0.2%) is similar to that seen in the general population (0.31%) in Italy. However, the course of the disease was mild in most patients. Biological therapies may likely lessen 'cytokine storm' of COVID-19, which sometimes lead to multiple organ failure, ARDS, and death.

Skin immunity and its dysregulation in atopic dermatitis, hidradenitis suppurativa and vitiligo.

While the epidermis is the frontline defense against infections and indeed, it is a peripheral lymphoid organ, the same immunological mechanisms may initiate and sustain pathological conditions. Indeed, a deregulated action against exogenous pathogens could activate a T cell response in atopic dermatitis, hidradenitis suppurativa and vitiligo. Atopic dermatitis (AD) is a chronic inflammatory skin condition with a complex pathophysiology. Although T helper 2 immunity dysregulation is thought to be the main cause of AD etiopathogenesis, the triggering mechanism is not well understood, and the treatment is often difficult. As the AD, hidradenitis suppurativa (HS) is a chronic inflammatory skin disease with a dramatic impact on the quality of life of the affected patients. The exact pathophysiology of HS is still unclear, but many evidences report a follicular obstruction and subsequent inflammation with TNF-α, interleukin (IL)-1ß, IL-10, and IL-17 involvement. Vitiligo is an autoimmune epidermal disorder which consists of melanocytes destruction and skin depigmentation. Melanocytes destruction is mainly due to their increased oxidative-stress sensitivity with a consequent activation of innate first and adaptative immunity (CD8+ T cells) later. The understanding of the triggering mechanisms of AD, HS and Vitiligo is pivotal to outline novel therapies aimed at regaining the physiological immune homeostasis of healthy skin. The aim of this review is to provide new insight on the pathogenesis of these skin diseases and to highlight on the new therapeutic approaches adopted in the treatment of AD, HS and Vitiligo.

Prevalence of cutaneous comorbidities in psoriatic patients and their impact on quality of life.

In contrast to the evidence for systemic co-morbidities, relatively few studies have examined the prevalence of cutaneous inflammatory co-morbidities in psoriatic patients. We conducted an observational multi-site study to measure the prevalence of cutaneous co-morbidities in adult patients with plaque psoriasis and to assess the relative impact on quality of life (QOL). Each patient attending one of the study clinics over a period of six months was evaluated to assess the presence of any concomitant skin inflammatory disease other than psoriasis at the time of the visit. Patients were also asked to complete QOL surveys at the initial visit, using DLQI, SF36, Skindex 29, and PDI. A total of 118 study participants (21.1%) had a cutaneous comorbidity. The most common cutaneous co-morbidities were rosacea (23 cases; 4.1%) and acne vulgaris (22 cases; 3.9%). Psoriatic patients with co-existing skin diseases had a worse QOL than those without, as evidenced by DLQI, Skindex 29, and PDI scores. Dermatologists should take a global approach to manage psoriatic patients by carefully evaluating the skin for any disorder and providing treatment to achieve "clean" skin.

Evaluation of alexithymia in patients affected by rheumatoid arthritis and psoriatic arthritis: A cross-sectional study.

Rheumatoid arthritis (RA) and psoriatic arthritis (PsA) are chronic autoimmune diseases leading to joint damage, functional limitation, and disability and are typically associated with several comorbidities. Alexithymia is a personality trait characterized by a disregulation of emotion processing and regulation of emotions that involves a dissociation of emotional and physical responses to life events. A broad association between alexithymia and symptoms as depression, inflammation, and pain has been demonstrated. We aimed at evaluate an association among inflammatory arthritis, as RA and PsA, and alexithymia, and a possible link with clinical characteristics and disease activity.In this cross-sectional study, we enrolled, from January to December 2017, patients affected by RA or PsA referring to the outpatient's clinic of the Rheumatology Unit of the University of Rome Tor Vergata. The 20-item Toronto Alexithymia Scale (TAS-20) was used to assess alexithymia. Disease activity, function, quality of life, and clinimetric indexes were assessed.A total of 50 RA patients and 51 PsA patients were enrolled. The TAS-20 score showed 38.6% (39/101) patients had alexithymia, 26.7% (27/101) patients were in the borderline of alexithymia and 34.7% (35/101) patients did not have alexithymia. A statistical significant association was observed between alexithymia and inflammatory indices (ESR: P = .029, CRP: P = .043) and between alexithymia and clinimetric parameters (ptVAS, pVAS, GH, P < .0001 for all comparisons). A significant trend of association has been demonstrated between alexithymia and female gender and concomitant steroid therapy. No correlations among variables such as age, duration of disease, and comorbidities and alexithymia status were observed.This study suggests that alexithymia assessment should be a part of the comprehensive management of RA and PsA patients.

Efficacy of sinecatechins 10% as proactive sequential therapy of external genital warts after laser CO2 ablative therapy: The PACT study (post-ablation immunomodulator treatment of condylomata with sinecatechins): a randomized, masked outcome assessment, multicenter trial.

External genital warts (EGW) are the most common viral sexually transmitted infection. Ablative treatments like cryotherapy, curettage, and CO2 laser therapies offer rapid onset of effect, fast clearance, and reduction of virus load. However, these procedures are associated with high recurrence rates (RRs) ranging from 20% to 77% in the short and medium terms and do not provide sustained clearance. After laser therapy removal of EGW, an RR up to 77% has been reported. Topical sinecatechins (TS) 10% is a patient-applied regimen for the treatment of EGW with a low RR (<6.5%) at three months after completion of the therapy in the pivotal trials conducted so far. Sinecatechins can be considered a suitable proactive sequential therapy (PST) after ablative strategies to obtain a low RR. So far, no prospective data are available regarding the efficacy of sinecatechins 10% as PST. We evaluated the efficacy and tolerability of TS 10% ointment applied twice daily in subjects with "difficult to treat" EGW after CO2 laser ablative treatment in a prospective controlled trial. A total of 87 subjects (76 men and 11 women; mean age 42 years) were enrolled in this three-month masked outcome assessment parallel group trial with imbalanced randomization allocation (2:1). One week after a successful CO2 laser treatment, 60 subjects were randomized to TS 10% treatment and 27 subjects to no treatment (control group: ConTRol (CTR); no sequential therapy). All patients had a history of an average of 4.5 previous ablative treatments in the last 12 months due to recurrent EGW. Mean (standard deviation) baseline number of treated lesions was 6.5 (2.7). One subject in the TS arm dropped out due to burning sensation after the application of the product. Therefore, 86 subjects completed the study. After three months, in the TS group, three subjects presented new EGW lesions (RR: 5%) on treated sites. In the CTR group, eight subjects presented new EGW lesions (RR: 29%) on treated sites (p = 0.0024; odds ratio: 0.16; 95% confidence interval: 0.04-0.68). In the TS group, 34 subjects (56%) reported mild to moderate erythema or burning sensation at the application site. In this prospective multicenter trial, the use of TS 10% as PST after ablative treatment with CO2 laser was associated with a lower recurrence rate of new EGW lesions in the short term in comparison with the control group. Comparative larger trials are warranted to evaluate the role of this approach as PST (Trial Registration Number: ISRCTN44037479).

Treating a Multidrug-Resistant Psoriatic HLA-C*18:01 Allele Carrier with Combination Ustekinumab Apremilast Therapy.

BACKGROUND: Nowadays, even though several biologic therapies are available to treat psoriasis, multidrug-resistant disease continues to be a therapeutic challenge. Combination therapy has therefore become increasingly important. In this context, apremilast, according to its safety profile, could easily be combined with biologics in patients with comorbidities and/or recalcitrant multidrug-resistant psoriasis. OBJECTIVE: Our goal is to share experience from our institution in the observation of a patient with severe chronic plaque psoriasis that was unresponsive to all anti-tumor necrosis factor-α treatment and to an anti-interleukin (IL)-17A drug and only partially responsive to ustekinumab, even in combination with apremilast. The patient carried a rare allele infrequently found in Caucasian people: human leukocyte antigen (HLA)-C*18:01. This allele has been found to be positively associated with psoriasis in Brazilian patients. METHODS: The patient was typed for the HLA-C locus at high resolution via polymerase chain reaction sequence-specific oligonucleotide probes (PCR-SSOP) using a commercial kit (LAB®Type, One Lambda Inc., Canoga Park, CA, USA). RESULTS: Our patient, previously described as having multidrug-resistant psoriasis, commenced ustekinumab and apremilast combination therapy. After 12 weeks, the Psoriasis Area Severity Index score had worsened, and we suspended combination therapy because the patient reported an absence of any benefit and was experiencing side effects from the induction therapy with apremilast. CONCLUSIONS: Expanding on the previously reported experience with this patient, we conclude that HLA-C*18:01 probably indicates a severe, recalcitrant, multidrug-resistant psoriasis phenotype for which proper therapy remains to be identified.

Effectiveness and safety of ustekinumab in naïve or TNF-inhibitors failure psoriatic arthritis patients: a 24-month prospective multicentric study.

The current prospective observational study aimed to evaluate the long-term (24 months), real-life effectiveness of ustekinumab in psoriatic arthritis (PsA). Consecutive patients with moderate-severe PsA and active psoriasis who begun ustekinumab treatment were evaluated prospectively (January 2015-March 2017). Clinimetric scores and biochemical values were assessed at baseline (T0), at 6 (T6), 12 (T12), and 24 (T24) months. Friedman test and generalized linear models were used to compare variables over time. Regression analysis to identify determinants of minimal disease activity (MDA) at T6 and of treatment discontinuation was conducted. Sixty-five patients (43.1% men; age 49.4 ± 11.6 years) were enrolled; ustekinumab was prescribed as a first (20%), second (33.8%), third (26.5%), fourth (15.4%), or fifth (4.6%) line biological therapy. Significant decrease in tender/swollen joints, Visual Analogue Scale of pain (VASp) and general health (VASgh), Disease Activity in PsA (DAPSA), Psoriasis Area Severity Index (PASI), Leeds Enthesitis Index (LEI), Health Assessment Questionnaire modified for spondyloarthritis (HAQ-S), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) was achieved. MDA was reached by 30.7, 47.0, and 34.0% of patients respectively at T6, T12, and T24. In multivariable models, mono-oligoarthritis was independently associated to MDA at T6 (OR 9.02; 95% CI 1.41, 57.71), while baseline CRP (OR 1.12; 95% CI 1.00, 1.26) and LEI (OR 0.50; 95% CI 0.25, 0.97) to ustekinumab discontinuation. More patients used disease-modifying antirheumatic drugs at T0 (35.3%) than at T24 (8.5%). Only nine episodes of infection and no serious adverse events were registered. In a real-life clinical setting, ustekinumab was safe and effective in PsA. Comedication tapering was often possible.

The Role of Pharmacogenetics in Chronic Plaque Psoriasis: Update of the Literature.

Psoriasis is a chronic inflammatory disease triggered by both genetic and environmental factors. Systemic and biologic therapies used to treat moderate-to-severe psoriasis show significant variability in efficacy, are associated with various degrees of toxicity, and, for biologic therapies, are expensive. There is a great need for non-invasive biomarkers to predict treatment outcomes of these therapies and to individualize care for patients with psoriasis. This article reviews currently recognized pharmacogenetic targets related to the treatment of chronic plaque psoriasis, in particular to biologic therapies. The use of pharmacogenetic and pharmacogenomic approaches to genetically profile patients will allow therapies to be targeted more precisely and safely to individual patients, to optimize the treatment of psoriasis, and minimize unnecessary costs. Characterizing patients with psoriasis according to common molecular mechanisms rather than by clinical phenotype may also allow more selective therapeutic agents to be targeted to genetically distinct groups of patients.

Tildrakizumab for treating psoriasis.

INTRODUCTION: Agents that block inflammatory pathways other than tumor necrosis factor (TNF) have represented new options for treating psoriasis in recent years. IL-23 is involved in regulating Th17 cells and is a potent activator of keratinocyte proliferation. Targeting IL-23p19 alone may be a promising treatment approach in patients with moderate-to-severe chronic plaque psoriasis, with a downregulation of Th17 and Th22 cell responses, while IL-12 blockade is not required to achieve efficacy in these patients. Areas covered: The authors review and provide an update on tildrakizumab, a humanized IgG1 monoclonal antibody that blocks the p19 subunit of IL-23. Expert opinion: Total skin clearance is an important treatment goal that has both measurable and clinically meaningful benefits. Meeting patient needs about total clearance, IL-23p19 inhibitors will obtain a specific position in the crowded psoriasis market. On the other hand, PASI 75 and PASI 90 response achieved by tildrakizumab in the phase II and III trials are less than the response achieved by the IL-17A inhibitors and other p19 competitors, possibly due to a less intensive dosing regimen, although direct comparisons cannot be made without a head-to-head randomized clinical trial. The main advantage of tildrakizumab is that it is dosed in a maintenance regimen of 12 weeks, and similar to ustekinumab, this is likely to encourage adherence and aid persistence to the drug.

HLA-C*06:02 Does Not Predispose to Clinical Response Following Long-Term Adalimumab Treatment in Psoriatic Patients: A Retrospective Cohort Study.

BACKGROUND: The genetic basis of predisposition to psoriasis is recognised; however, the response to psoriasis treatment in patients with different genetic predisposition is poorly understood. OBJECTIVE: To analyse the presence of the HLA-C*06:02 polymorphism in psoriatic patients treated with adalimumab. METHODS: Genomic DNA was extracted from whole blood of 122 patients with moderate-to-severe psoriasis treated with adalimumab for 3 years. Genotyping was performed using PCR. Disease severity was assessed by the Psoriasis Area and Severity Index (PASI) at day 0 and after 1, 3, 6, 12, 24 and 36 months. Logistic regression was used to evaluate the association between dependent variables (including HLA-C*06:02 status) and achievement of PASI 50, 75 and 90. RESULTS: No difference was observed after adalimumab treatment between C*06:02 positive (HLA-C*06:02-POS) patients (n = 46) and C*06:02 negative (HLA-C*06:02-NEG) patients (n = 76) over the 3-year follow-up period in terms of PASI response or time-course when PASI response was achieved. However, a small, but non-statistically significant difference was noted between genotypes for PASI 50 at 1 month (HLA-C*06:02-NEG: 44.7% vs. HLA-C*06:02-POS: 56.5%) and at 3 months (HLA-C*06:02-NEG: 71.1% vs. HLA-C*06:02-POS: 80.4%). Simple logistic regression analysis did not reveal an association between independent variables (including C*06:02 status) and PASI response; however, multivariate regression revealed that gender (females better than males) was associated with achievement of PASI 50 at month 1 (OR 0.34, 95% CI 0.16-0.72, p = 0.005) and of PASI 75 at 3 months (OR 0.36, 95% CI 0.16-0.8, p = 0.012). CONCLUSION: Adalimumab reduced long-term severity in patients with moderate-severe psoriasis, independent of their HLA-C*06:02 status.

IL12B (p40) Gene Polymorphisms Contribute to Ustekinumab Response Prediction in Psoriasis.

BACKGROUND: Psoriasis is characterized by multiple genetic variations. Some of these variations, such as the presence of HLA-Cw6 or TNFAIP3 single-nucleotide polymorphisms (SNPs), have been correlated to the response to biologic treatments. OBJECTIVE: The aim of our study was to evaluate the effects of IL12B and IL6 SNPs on the response to ustekinumab. METHODS: We retrospectively analyzed the genotypes of 64 patients who had been treated with ustekinumab for up to 1 year. Efficacy data were evaluated using 'intention to treat-last observation carried forward' analysis. RESULTS: We confirmed the positive role of HLA-Cw6 as a predictor of the response to ustekinumab and discovered that presence of the GG genotype on the IL12B rs6887695 SNP and absence of the AA genotype on the IL12B rs3212227 SNP significantly increase the probability of therapeutic success in HLA-Cw6 positive patients. CONCLUSIONS: The availability of pharmacogenetic data will influence therapeutic decisions in the clinical management of psoriatic patients.

Detection of adalimumab and anti-adalimumab levels by ELISA: clinical considerations.

Psoriasis (Ps) is a common and stigmatizing chronic inflammatory skin disease that may cause other chronic inflammatory conditions with overlapping pathology, such as rheumatoid arthritis (RA). Tumor necrosis factor (TNF) is a proinflammatory cytokine that plays a pivotal role in chronic inflammatory and autoimmune diseases such as uveitis, multiple sclerosis, systemic lupus, arthritis, Ps, and Crohn's disease. The TNF superfamily and receptors represent active targets for drug development. Anti-TNF biological therapies, such as infliximab, adalimumab (ADL), and etanercept, are effective in treating RA, spondyloarthritis, Ps, and inflammatory bowel diseases, but long-term treatment can induce anti-drug antibody (ADA) formation associated with lower drug levels and clinical nonresponse. An investigation of the relationship between serum ADL/anti-adalimumab antibody (AAA) concentration, and clinical response in moderate to severe Ps, confirmed an association between ADL and AAA levels and response. Although the detection of ADAs can be used to determine the cause of nonresponse and aid therapy decisions, the contrary observation of long-term responders with low drug levels and detectable ADA suggests that another mechanism is also involved.

Genetic variations in IL6 and IL12B decreasing the risk for psoriasis.

BACKGROUND: Psoriasis is a chronic inflammatory skin disorder. Recent studies associated a number of genetic variants to this immune-mediated pathology. OBJECTIVE: This study aims to assess whether the association between the non-susceptibility allelic variants of IL12B single-nucleotide polymorphism (SNPs) rs3212227 and rs6887695, IL23R SNPs rs11209026 and rs7530511, IL6 SNP rs1800795 and HLA-Cw6 could be correlated with decreased risk for psoriasis. MATERIAL AND METHODS: We genotyped 67 psoriasis patients and 69 healthy subjects for polymorphisms of IL12B rs3212227 and rs6887695, IL23R rs11209026 and rs7530511, IL6 rs1800795 and for the presence of HLA-Cw6. The patients and controls were recruited from Dermatology Department, part of "Tor Vergata" Clinic, Rome. Demographic data of the control group matched those of psoriasis patients, with a female:male ratio of 2.55 and mean age of 45.5±12.2 years for patients and 44.8±11.7 years for controls. RESULTS: The following genotypes were less frequent in patients: IL12B SNP rs6887695 CC (OR, 0.179; CI95% 0.046-0.699; p=0.01), IL6 SNP rs1800795 CG (OR, 0.367; CI95% 0.179-0.753; p=0.006) and IL6 SNP rs1800795 CC (OR, 0.069; CI95% 0.008-0.586; p=0.01). Also the HLA-Cw6 allele was rarely found in controls (OR, 0.459; CI95% 0.230-0.916; p=0.02). The multivariate analysis showed that the existence of at least one C allele in both IL12B SNP rs6887695 and IL6 SNP rs1800795 or the absence of HLA-Cw6 allele and at least one C allele in IL12B SNP rs6887695 or IL6 SNP rs1800795 is associated with a lower risk of psoriasis (OR, 0.185; CI95% 0.037-0.929; p=0.04). The presence of at least one C allele in both IL12B SNP rs6887695 and IL6 SNP rs1800795 and the absence of HLA-Cw6 allele decreased even further the risk of psoriasis (OR, 0.038; CI95% 0.006-0.244; p=0.001). CONCLUSION: We report carriers of variations in the IL6, IL12B and absence of HLA-Cw6 as having decreased risk for psoriasis.

Long-term efficacy of adalimumab in generalized pustular psoriasis.

BACKGROUND: Generalized pustular psoriasis (GPP) is a rare form of psoriasis that may either be preceded by plaque psoriasis or arise de novo, classically after withdrawal of systemic glucocorticosteroids. Adalimumab is a fully human, anti-TNF-alpha monoclonal antibody that specifically blocks the interaction of TNF-alpha with the p55 and the p75 TNF-alpha cell surface receptors. AIM: To demonstrate the efficacy and tolerability of adalimumab in the treatment of GPP. CASE REPORT: A 50-year-old woman had suffered from severe pustular psoriasis for 10 years and psoriatic arthritis for 8 years and received treatment with adalimumab, in monotherapy, 40 mg subcutaneously once a week for 72 weeks. DLQI, PDI and SKINDEX 29 score were used to assess patient compliance and satisfaction. RESULTS: In our case, control of disease manifestations was rapid and clinical remission persisted during the treatment course until the 72th week. Treatment tolerability and compliance were consistent. The patient experienced a dramatic improvement of quality of life instruments. CONCLUSION: In this case, adalimumab has been demonstrated to be effective, safe and appropriate for long-term use, indicating a beneficial effect on quality of life parameters.

Adalimumab for severe psoriasis and psoriatic arthritis: an open-label study in 30 patients previously treated with other biologics.

BACKGROUND: Psoriasis is a chronic, genetically determined, immune-mediated, inflammatory skin disease affecting approximately 2% to 3% of the Caucasian population. Previously reported data demonstrated adalimumab to be an efficacious treatment of psoriatic arthritis and plaque-type psoriasis. Adalimumab is a fully human monoclonal antibody IgG1 against tumor necrosis factor alpha. OBJECTIVE: To evaluate the efficacy and safety of adalimumab, in the treatment of psoriasis patients whose disease is refractory to treatment with other biologic agents. PATIENTS AND METHODS: Thirty patients affected by plaque-type psoriasis with or without psoriatic arthritis, unresponsive to conventional and biologic systemic treatments were enrolled. Adalimumab was administered in monotherapy, at a dosage of 40 mg, subcutaneously, once a week. RESULTS: At week 12, 26 of 30 patients (87%) achieved Psoriasis Area and Severity Index (PASI) 75; at week 24, 25 of 30 patients (83%) achieved PASI 75. Concerning psoriatic arthritis, at week 24, the mean Health Assessment Questionnaire score improved from 0.99 to 0.2, Ritchie articular index from 10.15 to 2, and Pain Visual Assessment Score from 6.32 to 1.2. Furthermore, therapy with adalimumab considerably enhanced patients' quality of life as assessed by two measures (Dermatology Life Quality Index, Psoriasis Disability Index). Adalimumab was generally safe and well tolerated. LIMITATIONS: This is not a randomized placebo-controlled study and is restricted to a small number of patients. CONCLUSIONS: In our experience, although preliminary, monotherapy with adalimumab 40 mg weekly proved to be an effective and safe treatment for the management of plaque-type psoriasis and psoriatic arthritis, with a rapid onset of action in patients whose disease had been refractory to both conventional and biologic agents.