Global Assessment Of Psoriasis Research Articles

Effectiveness and safety of risankizumab in VEry severe plaque psoriasis: a real-life retrospective study (VESPA-Study)

Background The recent introduction of biological drugs specifically targeting the interleukins involved in psoriasis pathogenesis revolutionized the therapeutic scenario of moderate to severe forms of psoriasis. Among these, risankizumab, an anti-IL-23, was shown to be effective both in clinical trials and real-life experiences. However, data on its use on very severe forms of psoriasis, defined by a Psoriasis Area Severity Index (PASI) of at least 30, are scant. In this context, our study aimed to investigate the outcomes of patients with very severe psoriasis, and the involvement of difficult-to-treat areas treated with risankizumab for up to 2 years. Methods A retrospective, observational study enrolled patients with very severe plaque psoriasis and the involvement of difficult-to-treat areas undergoing treatment with risankizumab. Clinical and demographic data were collected at baseline. Moreover, at baseline and each dermatological examination (16, 28, 40 and 104 weeks), clinical improvement was measured using the percentage of patients achieving PASI 75/90/100 response, site-specific Psoriasis Global Assessment and Dermatology Life Quality Index. Results At baseline, the mean PASI was 35.1 ± 5.1. A significant reduction was observed since week 16 and maintained up to week 104. Moreover, the Psoriasis Global Assessment and Dermatology Life Quality Index improved as well. Conclusions Risankizumab showed to be effective and safe in patients affected by very severe forms of psoriasis with the involvement of difficult-to-treat areas.

Efficacy of calcipotriol plus betamethasone dipropionate foam on psoriatic skin lesions beyond human eyes: An observational study.

Background and AimsCalcipotriol plus betamethasone dipropionate foam has been developed as a new topical therapeutic option for psoriasis, whose effect has been documented mainly on clinical basis.MethodsWe decided to evaluate its efficacy on 11 patients, not only at the clinical level (by using Psoriasis Area Severity Index [PASI], Dermatology Life Quality Index [DLQI], and Psoriasis Global Assessment [PGA] clinimetric indexes) but especially from a subclinical viewpoint (by using videocapillaroscopy and thermography).ResultsAfter 4 weeks of treatment with calcipotriol plus betamethasone dipropionate foam, there was a marked reduction in all three clinimetric indixes PASI, PGA, and DLQI (DLQI mean value decreased from 13.45 ± 3.59 to 6.82 ± 3.31 (p = 0.001), PASI from 7.909 ± 2.857 to 4.582 ± 2.422 (p = 0.001), PGA from 1.8 ± 0.6 to 0.7 ± 0.4 (p = 0.002). From thermographic survey, a significant reduction of mean value of ΔT (temperature difference [°C] between center of the lesions and their periphery [healthy skin]), from 0.28 ± 0.99 to −0.42 ± 0.39 (p = 0.058), was observed. An exceptional reduction of capillaries of psoriatic plaques was detected through videocapillaroscopy (capillary density decreased from 27.91 ± 6.70 capillaries/mm2 to 4.54 ± 2.77 capillaries/mm2 (p = 0.001), with an 83.73% reduction).ConclusionOur results demonstrate both clinical and subclinical efficacy of calcipotriol plus betamethasone dipropionate foam on psoriatic skin lesions. The subclinical improvement detected, not only demonstrates that the therapeutic effect of foam is truly due to a decrease in inflammation, but, being earlier and more effectively detectable than clinical benefit, suggests future applications of thermography and videocapillaroscopy in evaluating the in vivo effect of therapies for psoriasis, and, in general, the course of the disease “beyond human eyes.”

Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies

Objectives Evaluate relationships between changes in dermatologic assessments and quality of life (QoL) measures; quantify dermatologic symptom severity impacts on QoL in patients with psoriatic arthritis (PsA) treated with tofacitinib. Methods Data were from two phase III studies; patients received tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg every other week, or placebo advancing to tofacitinib 5 or 10 mg BID at Month 3. Repeated measures longitudinal models assessed relationships between dermatologic assessments (predictors) Itch Severity Item (ISI), Physician’s Global Assessment of Psoriasis (PGA-PsO), and Patient’s Global Joint and Skin Assessment-Visual Analog Scale-Psoriasis question (PGJS-VAS-PsO), and QoL measures (outcomes) Dermatology Life Quality Index (DLQI) and Short Form-36 Health Survey Version 2 (SF-36v2). Models included one predictor and one outcome. Results Direct, approximately linear relationships existed between predictors and outcomes. ISI/PGA-PsO/PGJS-VAS-PsO improvements from baseline of ≥3/≥2/≥40-mm VAS corresponded with clinically meaningful DLQI improvements; improvements from baseline of ≥4/≥3/≥40-mm VAS generally corresponded with clinically meaningful improvements across component scores and all SF-36v2 domains. Conclusion Substantial links exist between dermatologic symptoms and QoL in patients with PsA, potentially informing patient-centered care and research. Rheumatologists should be aware of dermatologic manifestations and QoL impacts in patients with PsA. ClinicalTrials.gov NCT01877668; NCT01882439

Higher rates of skin clearance and efficacy in challenging body areas are associated with better health‐related quality of life following ixekizumab maintenance treatment in pediatric patients with plaque psoriasis

Background/ObjectivesInformation is limited on the relationship between skin clearance, resolution of challenging body areas, and improvement of patient‐reported outcomes (PROs) in pediatric psoriasis. Ixekizumab, a high‐affinity monoclonal antibody that selectively targets interleukin‐17A, is approved for the treatment of moderate‐to‐severe psoriasis in patients aged 6 to <18 years. This study examines improvement in psoriasis clearance in challenging body areas in pediatric patients relative to health‐related quality of life.MethodsData from the IXORA‐PEDS trial (NCT03073200) were analyzed, and changes from baseline were measured for overall Psoriasis Area and Severity Index (PASI), static Physicians' Global Assessment of psoriasis (sPGA), Psoriasis Scalp Severity Index (PSSI), Palmoplantar Psoriasis Area and Severity Index (PPASI), and Nail Psoriasis Severity Index. Rates of Dermatology Life Quality Index (DLQI), or Children's DLQI (CDLQI), scores of 0 or 1 were evaluated using the Cochran‐Armitage trend test.ResultsHigher rates of DLQI/CDLQI (0,1) scores were significantly associated with greater PASI and PSSI responses at both Week 12 and Week 48 (p < .0001). A significant association was also observed between DLQI/CDLQI (0,1) and sPGA scores (p < .0001). Significantly higher rates of DLQI/CDLQI (0,1) scores were achieved in patients with greater levels of palmoplantar clearance as measured by PPASI at Week 12 (p = .0139), but significance was not sustained at Week 48 (p = .0896).ConclusionsGreater skin clearance and scalp resolution are associated with better PROs over a short‐term (12‐week) and long‐term (48‐week) period. This demonstrates that greater improvement of skin clearance and scalp resolution may benefit quality of life in pediatric patients with psoriasis.

Itch as Major Mediator of Effect of Tofacitinib on Health-Related Quality of Life in Psoriatic Arthritis: A Mediation Analysis.

Patients with psoriatic arthritis (PsA) experience impaired health-related quality of life (HRQoL). Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA, which has been associated with improvements in dermatologic endpoints in patients with PsA. To assess the extent to which tofacitinib affects patient HRQoL via improvements in dermatologic symptoms, including itch, data were pooled from patients with PsA who received tofacitinib in phase III studies (NCT01866668 and NCT01882439). Mediation modeling assessed the indirect effects (via Itch Severity Item [ISI] and Physician’s Global Assessment of Psoriasis [PGA-PsO]) and direct effects (via all other factors) of tofacitinib treatment on dermatology-specific HRQoL (measured by Dermatology Life Quality Index [DLQI]). In the initial model, the treatment effect on DLQI was largely mediated by itch (ISI; p < 0.0001) and PGA-PsO (p < 0.01). The model was re-specified to assess the indirect effects only of itch and PGA-PsO on DLQI. Here, 17.7% of the treatment effect on DLQI was attributable to PGA-PsO (p = 0.0006), and 82.3% to itch (p < 0.0001). Tofacitinib-dependent improvements in DLQI were primarily mediated by itch relief, in addition to improvements in PGA-PsO.

Efficacy and Safety of Novel Formulation of Clobetasol Propionate 0.025% Cream in Indian Moderate-to-Severe Psoriasis Patients: Phase-2a, Randomized 3-Arm Study.

IntroductionClobetasol propionate (0.05% standard dose formulation), a topical corticosteroid, leads to systemic side-effects like hypothalamic–pituitary–adrenal (HPA) axis suppression at doses as low as 2 g/day. The aim of this study was to evaluate HPA axis suppression, efficacy, and safety of clobetasol propionate (0.025%, formulation 5 and 13) versus currently marketed 0.05% cream in Indian patients with moderate-to-severe psoriasis.MethodsIn this phase 2a investigator-blinded study, patients aged ≥ 18 years with moderate-to-severe psoriasis were randomized 1:1:1 to receive clobetasol propionate 0.025% formulation 5, or 13, or 0.05% cream; twice daily for 28 days. Safety endpoints included adrenocorticotropic hormone (ACTH) test results at day 28 (primary), and local tolerability at each visit (burning/stinging/pruritus, secondary). Efficacy endpoints included Psoriasis Global Assessment (PGA) score.ResultsOverall, 88 patients received clobetasol propionate 0.025% formulation 5 and 13 (n = 29 for both) and 0.05% cream (n = 30). At day 28, the proportion of patients with an abnormal ACTH stimulation test (cortisol levels ≤ 18 µg/dl) was numerically lower in 0.025% formulations: 5 (20.7%) and 13 (17.2%) compared with 0.05% cream (30.0%), (p = 0.320). Decrease in burning/stinging /pruritus scores were comparable in all treatment groups and PGA success rates were higher with 0.025% formulations: 5 (38.9%) and 13 (36.8%) compared with 0.05% cream (30.8%).ConclusionClobetasol propionate 0.025% could be an effective treatment for moderate-to-severe psoriasis compared with 0.05% cream, demonstrating comparable efficacy with a better systemic safety profile.Trial Registration NumberREF/2018/01/016779.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13555-021-00591-z.

Tofacitinib in psoriatic arthritis patients: skin signs and symptoms and health-related quality of life from two randomized phase 3 studies.

BackgroundPsoriatic arthritis (PsA) is a chronic, systemic immune‐mediated inflammatory musculoskeletal disease. The onset of dermatologic symptoms often precedes rheumatic manifestations. Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA that has been shown to improve dermatologic symptoms in patients with PsA.ObjectivesTo investigate the efficacy of tofacitinib in improving dermatologic endpoints in adult patients with active PsA.MethodsThis analysis included data from two placebo‐controlled, double‐blind, phase 3 studies in patients with active PsA and an inadequate response (IR) to ≥1 conventional synthetic disease‐modifying antirheumatic drug (csDMARD) who were tumor necrosis factor inhibitor (TNFi)‐naïve (OPAL Broaden; NCT01877668) or an IR to ≥1 TNFi (OPAL Beyond; NCT01882439). Patients had active plaque psoriasis at screening and received a stable dose of one csDMARD during the study. Patients were randomized to tofacitinib 5 mg twice daily (BID), 10 mg BID, adalimumab 40 mg subcutaneous injection once every 2 weeks (OPAL Broaden only) or placebo (to Month 3). Dermatologic endpoints: Psoriasis Area and Severity Index (PASI) total score; PASI90 overall; PASI75 and PASI90 by baseline PASI severity; Physician’s Global Assessment of Psoriasis; Nail Psoriasis Severity Index; Dermatology Life Quality Index total and sub‐dimension scores; Itch Severity Item; and Patient’s Global Joint and Skin Assessment‐Visual Analog Scale‐Psoriasis question.ResultsIn patients with active PsA, including those stratified by mild or moderate/severe dermatologic symptoms, greater improvements from baseline and percentage of responders were observed in tofacitinib‐treated patients vs. placebo for the majority of analyzed dermatologic endpoints at Months 1 and 3, and improvements were maintained to Month 12 in OPAL Broaden and Month 6 in OPAL Beyond. Similar effects were observed in adalimumab‐treated patients vs. placebo in OPAL Broaden across dermatologic endpoints.ConclusionsTofacitinib provides a treatment option for patients with active PsA, including the burdensome dermatologic symptoms of PsA.

Results of the long-term observational noninterventional prospective study BODYGUARD in psoriasis patients

Introduction. Currently there is insufficient data regarding routine use of various topical treatments for plaque psoriasis outside from randomized clinical trials, their efficacy, cost-effectiveness and perception by dermatologists and patients. The primary rationale for this study was local data generation for the long-term (up to 52 weeks) treatment of body psoriasis in Russian patients’ population with fixed-dose combination of calcipotriol and betamethasone dipropionate in the formulation of gel to evaluate patient’s adherence to the therapy and their satisfaction level.Materials and methods. Primary study objectives were evaluation of the long-term (up to 52 weeks) treatment success of body psoriasis with fixed-dose combination of calcipotriol and betamethasone dipropionate gel by Physician (Physician Psoriasis Global Assessment (PsGA, 5-point scale)) and by patient (Patient’s Global Psoriasis Assessment (PaGA, 5-point scale) and overall patient’s satisfaction using 4-point scale), patient’s satisfaction with the treatment via Patient Preference Questionnaire (PPQ), patients’ adherence to the treatment using Questionnaire of Adherence, impact of treatment on patients’ quality of life using DLQI questionnaire, and patients’ readiness to buy topical therapy product out of pocket based on consumption of the study medication during follow up period. Patients received treatment with topical calcipotriol/betamethasone gel which was prescribed as a routine medication without connection to the study purposes for up to 8 weeks. After the treatment patients were followed up for up to 52 weeks; during this period they were allowed to continue treatment with either maintenance or intermittent schedule. 128 dermatologists participated in the study, 612 patients with body plaque psoriasis (mean age 42.0 ± 13.30 years) were included; from this sample 544 (88.7 %) patients underwent follow up.Results. All 612 included patients received initial therapy with calcipotriol/betamethasone gel; during follow-up period 410 (76.1 %) patients received treatment by any schedule (out of 539 assessed). Overall treatment success based on average PsGA score: initially 3.0 ± 0.54, after appr.8 weeks — 1.3 ± 0.80 and after appr.52 week 1.1 ± 0.96; based on average PaGA score — initially 3.0 ± 0.54, after appr.8 weeks — 1.5 ± 0.88 and after appr.52 week 1.1 ± 0.99. The proportion of patients which described their overall satisfaction with the treatment as “satisfied” or “absolutely satisfied” equaled 92.3 % at visit at the end of active treatment and 93.1 % at visit up to 52 weeks afterwards. Also at visit at the end of active treatment 93.8 % of patients considered their current treatment as “more effective” than previous topical treatment they received. Patients’ adherence to the therapy was satisfactory — average application rate of calcipotriol/betamethasone (should be applied daily) gel at the last 7 days of treatment at visit at the end of active treatment comprised 5.6 ± 2.6 days, which means that 6 out of 7 days of the treatment were not missed. Initial DLQI score was 13.6 ± 5.95 and it reduced down to 3.89 ± 5.95 at visit at the end of active treatment (p &lt; 0.001) reflecting positive impact of successful therapy on patients’ psychosocial wellbeing.Discussion. Results of this study provides additional information regarding routine topical therapy in patients with plaque psoriasis. These findings demonstrate that the therapy of body plaque psoriasis with calcipotriol/betamethasone gel is effective both in short and long term according to the evaluation by dermatologists and by patients themselves. This therapy provides good rate of adherence and patients’ satisfaction as well as affects positively at patients’ psychosocial wellbeing assessed by DLQI score.

Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis

BackgroundTo evaluate the measurement properties (e.g., content validity, reliability, and ability to detect change) of the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale in patients with active psoriatic arthritis (PsA).MethodsOne-on-one semi-structured qualitative interviews with adult patients with active PsA evaluated the content validity of FACIT-Fatigue. Quantitative measurement properties were evaluated using data from phase III tofacitinib randomized controlled trials (RCTs) in PsA: OPAL Broaden (NCT01877668) and OPAL Beyond (NCT01882439).ResultsOf 12 patients included in the qualitative study, 2 (17%) had mild, 8 (67%) had moderate, and 2 (17%) had severe PsA disease activity; 7 (58%) attributed fatigue to PsA, and 7 (58%) rated fatigue as important or extremely important. Most patients considered the FACIT-Fatigue items relevant to their PsA experience, and understood item content and response options as intended. In the psychometric analysis of RCT data, a second-order confirmatory factor model fit the data well (Bentler’s Comparative Fit Index ≥0.92). FACIT-Fatigue demonstrated good internal consistency (Cronbach’s coefficient α ≥ 0.90), test-retest reliability (Intraclass Correlation Coefficient ≥ 0.80) and a strong correlation with SF-36 Vitality (r > 0.80). A robust relationship between disease activity (based on Patient’s Global Assessment of Psoriasis and Arthritis) and FACIT-Fatigue was observed (effect sizes > 1.4), with clinically important difference for the FACIT-Fatigue total score estimated as 3.1 points, and the responder definition estimated as a 4-point improvement for FACIT-Fatigue total score.ConclusionFatigue was confirmed to be an important symptom to patients with PsA, and FACIT-Fatigue was found to be a reliable and valid measure in this population.

Efficacy and Safety of Apremilast Monotherapy for Moderate to Severe Psoriasis: Retrospective Study.

Apremilast is a new oral drug for the treatment of moderate to severe plaque psoriasis that reduces inflammation by inhibiting phosphodiesterase 4. Its efficacy and safety data are limited; hence, real-world outcomes are important for elucidating the full spectrum of its adverse events (AEs) and expanding generalizability of clinical trial findings. Assess the efficacy and safety of apremilast monotherapy in real-world practice. A retrospective chart review was conducted in 2 academic dermatology practices. Efficacy was measured as the proportion of patients achieving a ≥75% reduction from baseline Psoriasis Area and Severity Index score (PASI-75) or a Psoriasis Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) at 16 weeks. Safety was measured as the proportion of patients reporting ≥1 AE at 16 weeks. Thirty-four patients were included. 19 patients (55.9%) achieved PASI-75 or PGA 0/1. 23 patients (67.6%) experienced ≥1 AEs. Five patients (14.7%) withdrew treatment prior to week 16 due to AEs. One patient withdrew treatment due to mood lability and depression. Common AEs included headache (32.4%), nausea (20.6%), diarrhoea (14.7%), weight loss (8.8%), and loose stool (8.8%). Apremilast monotherapy had higher efficacy with similar safety outcomes in the real world compared to clinical trials. There were higher proportions of reported headaches compared to clinical trials. This study supports the apremilast monotherapy clinical trial findings, suggesting that it has an acceptable safety profile and significantly reduces the severity of moderate to severe plaque psoriasis. Limitations include the retrospective nature of the study.

Betamethasone valerate dressing is non‐inferior to calcipotriol–betamethasone dipropionate ointment in the treatment of patients with mild‐to‐moderate chronic plaque psoriasis: results of a randomized assessor‐blinded multicentre trial

BackgroundA ready-to-use betamethasone valerate 0.1% (BMV) dressing was found to be superior to placebo dressing and a reference 0.1% BMV cream in the treatment of patients with chronic plaque psoriasis (CPP).MethodsThis multicentre, prospective, randomized, investigator-blinded, controlled, non-inferiority trial compared the efficacy and safety of the BMV dressing to the calcipotriol–betamethasone dipropionate (CBD) ointment during a 4-week treatment of patients with mild to moderate CPP. The primary efficacy endpoint was the 4-item psoriasis total severity score (TSS-4) at week 4, and the associated non-inferiority margin was 1 point. Secondary outcome measures included the psoriasis global assessment (PGA) score and patients’ quality of life (QoL). Safety was assessed through adverse events (AE) reporting in each treatment group.ResultsOf 325 screened patients, 324 were randomized to BMV (N = 165) or CBD (N = 159), and were considered evaluable for the safety and intention-to-treat (ITT) efficacy analyses. Per protocol (PP) populations included 133 and 131 patients in the BMV and CBD groups respectively. The mean adjusted TSS-4 significantly decreased through the study from baseline in both groups. The PP (primary) analysis of week 4 data revealed a −0.288 (95% CI: −0.610 to 0.034) not significant between-group difference in adjusted means, demonstrating non-inferiority of BMV to CBD. Non-inferiority was also demonstrated in the ITT analysis. The PGA and other secondary outcomes were significantly improved from baseline in both groups at week 4. The QoL score was slightly better in the CBD group at week 4, but no difference was observed at follow-up. No safety or tolerability concerns were observed in either group.Conflicts of interestCentro Studi GISED, the centre led by LN, received a grant from IBSA Institut Biochimique SA. VF is an employee of IBSA Institut Biochimique SA.

Validation of the physician's global assessment of psoriasis of the hands and/or feet as a clinical endpoint

Validation of the physician's global assessment of psoriasis of the hands and/or feet as a clinical endpoint

Efficacy and Safety of the Betamethasone Valerate 0.1% Plaster in Mild-to-Moderate Chronic Plaque Psoriasis

Corticosteroids are a versatile option for the treatment of mild-to-moderate psoriasis due to their availability in a wide range of potencies and formulations. Occlusion of the corticosteroid is a widely accepted procedure to enhance the penetration of the medication, thereby improving its effectiveness. Betamethasone valerate (BMV) is a moderately potent corticosteroid that is available as a cream, ointment, and lotion. A ready-to-use occlusive dressing, which provides a continuous sustained release of BMV, has been developed for the treatment of psoriasis. To evaluate the efficacy and safety of a new BMV 0.1% plaster compared with a BMV 0.1% cream in patients with mild-to-moderate chronic plaque psoriasis. This was a prospective, randomized, assessor-blind, parallel-group, active-controlled, multicenter, phase III study. Eligible outpatients (aged ≥18 years) with a diagnosis of stable, chronic plaque psoriasis vulgaris with two to four plaques on extensor surfaces of limbs were randomized to receive BMV 0.1% plaster or BMV 0.1% cream for 3-5 weeks; patients with resolution of target plaques then entered a 3-month, treatment-free, follow-up period. The number of patients showing clearing of plaques (remission) at 3 weeks (primary endpoint) and at 5 weeks was independently evaluated from digitized images of target plaques by two blinded assessors, and also assessed by the investigator and patient. Additional endpoints were (i) change from baseline in target plaque size and in Psoriasis Global Assessment (PGA) score, as evaluated by the blinded assessors, investigator, and patient; (ii) change from baseline in symptom (itching, soreness) severity; (iii) treatment satisfaction and ease of use; (iv) clearing and relapse during the follow-up period; and (v) adverse events (AEs). Patients (n = 231) were screened and randomized to treatment with BMV 0.1% plaster (n = 116) and BMV 0.1% cream (n = 115). Significantly more patients achieved clearing after 3 weeks' treatment with BMV plaster than with BMV cream (Cochran-Mantel-Haenszel test, p < 0.001); this difference was maintained at 5 weeks. The total plaque area decreased to a larger extent for the BMV plaster group compared with the BMV cream group (analysis of covariance [ANCOVA] model, p = 0.017 at week 5). PGA scores were significantly lower after 3 and 5 weeks' treatment with BMV plaster (ANCOVA model, all p ≤ 0.016 vs BMV cream). Both treatments reduced itching and soreness to a similar degree, and the incidences of relapse during the follow-up period were comparable between treatment groups. There were no significant differences in AEs between treatment groups. BMV 0.1% plaster is more efficacious than BMV 0.1% cream in the treatment of patients with mild-to-moderate chronic plaque psoriasis in a clinical setting resembling daily clinical practice.

Abatacept in the treatment of patients with psoriatic arthritis: Results of a six‐month, multicenter, randomized, double‐blind, placebo‐controlled, phase II trial

To assess the safety and efficacy of abatacept, a selective T cell costimulation modulator, in patients with psoriatic arthritis (PsA). In this 6-month, multicenter, randomized, double-blind, placebo-controlled, phase II study, 170 PsA patients with a psoriasis target lesion (TL) ≥2 cm who had previously taken disease-modifying antirheumatic drugs (DMARDs), including anti-tumor necrosis factor (anti-TNF) agents, were randomized (1:1:1:1) to receive placebo or abatacept at doses of 3 mg/kg, 10 mg/kg, or 30/10 mg/kg (2 initial doses of 30 mg/kg, followed by 10 mg/kg) on days 1, 15, and 29 and then once every 28 days thereafter. The primary end point was the American College of Rheumatology 20% criteria for improvement (ACR20 response) on day 169. Other key end points were magnetic resonance imaging (MRI) scores for joint erosion, osteitis, and synovitis, scores on the Health Assessment Questionnaire (HAQ) and the Short Form-36 (SF-36) health survey, the investigator's global assessment of psoriasis, the TL score, and the Psoriasis Area and Severity Index (PASI) score. Proportions of patients achieving an ACR20 response were 19%, 33%, 48%, and 42% in the placebo, the abatacept 3 mg/kg, the abatacept 10 mg/kg, and the abatacept 30/10 mg/kg groups, respectively. Compared with placebo, improvements were significantly higher for the abatacept 10 mg/kg (P = 0.006) and 30/10 mg/kg (P = 0.022) groups, but not for 3 mg/kg group (P = 0.121). All abatacept regimens resulted in improved MRI, HAQ, and SF-36 scores, with 10 mg/kg showing the greatest improvements. Improvements in the TL and PASI scores were observed in all abatacept arms; a response according to the investigator's global assessment was seen only with 3 mg/kg of abatacept. The safety profiles were similar among the treatment arms. The results of this study suggest that 10 mg/kg of abatacept, the approved dosage for rheumatoid arthritis and juvenile idiopathic arthritis, may be an effective treatment option for PsA.

National survey of patients with psoriatic arthritis in Spain: disease activity, pharmacological therapy and impact on quality of life

Methods Cross-sectional, multicenter, national survey. The following data were collected: age, sex, type of psoriasis, swollen and tender joint counts (SJ 44/TJ 46), ESR (mm/1hora), CRP (mg/dL), DAS28, Psoriasis Global Assessment (PGA), Physician Global Assessment (PhyGA), Patient Global Assessment (PatGA), pharmacological therapy taken (AINEs, glucocorticoids, DAMARDs, and anti-TNFalfa therapy), Visual Analogue Scale (VAS) of pain, Disease impact as measured by VAS in the personal, occupational and social spheres, Health Assessment Questionnaire (HAQ) and Dermatology Life Quality Index (DLQI).

Effectiveness of adalimumab in treating patients with active psoriatic arthritis and predictors of good clinical responses for arthritis, skin and nail lesions

Objectives:To evaluate the effectiveness of adalimumab in patients with psoriatic arthritis (PsA) and identify predictors of good clinical response for joint and skin lesions.Methods:Patients received adalimumab 40 mg every other...

Measures of disease severity and life quality in patients with psoriasis

Psoriasis is a common and chronic disease in dermatological clinical settings. Dermatologists often estimate the impact of the disease on patients by their intuition. Accurate measurement of psoriasis disability is essential for the development of treatment strategy and evaluation of its efficacy. This paper describes several measures of psoriasis severity which involve the rating of symptom (such as psoriasis area and severity index (PASI), psoriasis global assessment (PGA) and lattice system physician's global assessment (LS-PGA)) and health-associated life quality (including general health questionnaires, dermatology specific questionnaires, disease specific questionnaires), as well as the criteria for definition of severe psoriasis. Key words: Psoriasis; Quality of life; Severity of illness index

International multicenter psoriasis and psoriatic arthritis reliability trial for the assessment of skin, joints, nails, and dactylitis

Clinical trials in psoriasis and psoriatic arthritis (PsA) involve assessment of the skin and joints. This study aimed to determine whether assessment of the skin and joints in patients with PsA by rheumatologists and dermatologists is reproducible. Ten rheumatologists and 9 dermatologists from 7 countries met for a combined physical examination exercise to assess 20 PsA patients (11 men, mean age 51 years, mean PsA duration 11 years). Each physician assessed 10 patients according to a modified Latin square design that enabled the assessment of patient, assessor, and order effect. Tender joint count (TJC), swollen joint count (SJC), dactylitis, physician's global assessment (PGA) of PsA disease activity (PGA-PsA), psoriasis body surface area (BSA), Psoriasis Area and Severity Index (PASI), Lattice System Physician's Global Assessment of psoriasis (LS-PGA), National Psoriasis Foundation Psoriasis Score (NPF-PS), modified Nail Psoriasis Severity Index (mNAPSI), number of fingernails with nail changes (NN), and PGA of psoriasis activity (PGA-Ps) were assessed. Variance components analyses were carried out to estimate the intraclass correlation coefficient (ICC), adjusted for the order of measurements. There is excellent agreement (ICC >/=0.80) on the mNAPSI, substantial agreement (0.6 >/= ICC < 0.80) on the TJC, PASI, and NN, moderate agreement (0.4 >/= ICC < 0.60) on the PGA-Ps, LS-PGA, NPF-PS, and BSA, and fair agreement (0.2 >/= ICC < 0.40) on the SJC, dactylitis, and PGA-PsA. The only measure that showed a significant difference between dermatologists and rheumatologists was dactylitis (P = 0.0005). There is substantial to excellent agreement on the TJC, PASI, NN, and mNAPSI among rheumatologists and dermatologists.

Comparison of clinical and pharmacokinetic profiles of etanercept 25 mg twice weekly and 50 mg once weekly in patients with psoriasis

Etanercept is a tumour necrosis factor antagonist that is approved in the U.S.A., Canada and Europe for treating adult patients with chronic moderate to severe plaque psoriasis. To assess whether clinical efficacy, safety and pharmacokinetic (PK) profiles of etanercept 50 mg once weekly are comparable to etanercept 25 mg twice weekly. Patients from a U.S. phase 3 study and a global phase 3 study were subsequently enrolled in an open-label extension study (extension study) where they all received etanercept at a dose of 50 mg once weekly for an initial 12 weeks. Patients who had received at least 24 weeks of etanercept 25 mg twice weekly in the global phase 3 study and were enrolled in the extension study (n = 265) were assessed for efficacy and safety at extension study baseline and after 12 weeks of etanercept 50 mg once weekly. Efficacy endpoints included the Psoriasis Area and Severity Index (PASI), the Dermatology Life Quality Index and the Physician's Global Assessment of psoriasis. In addition, PK profiles from patients in the U.S. phase 3 study were compared with PK profiles from another set of patients in the extension study. Comparison was made between a subset of patients receiving etanercept 25 mg twice weekly dosing in the U.S. phase 3 study (n = 13) and those receiving etanercept 50 mg once weekly in the extension study (n = 84). The mean PASI score was 5.77 at extension study baseline after treatment with etanercept 25 mg twice weekly, which was sustained at 5.82 after 12 weeks of etanercept 50 mg once weekly. Similar results were observed in other efficacy endpoints. Etanercept 50 mg once weekly was generally well tolerated. No new safety findings were reported. PK profiles overlapped extensively between the two dosing regimens. In this report, we demonstrate that efficacy, safety and PK profiles were comparable between etanercept 25 mg twice weekly and 50 mg once weekly in patients who had received at least 24 weeks of etanercept 25 mg twice weekly prior to receiving etanercept 50 mg once weekly in the extension study.

Treatment of psoriasis with adalimumab

Adalimumab is an anti-tumour necrosis factor agent of use in psoriatic arthritis. The objective of this study was to assess the efficacy and safety of adalimumab in patients with plaque psoriasis unresponsive to previous therapies. We present nine patients with psoriasis and psoriatic arthropathy treated with adalimumab, including a woman with a history of breast cancer and a man with hepatitis C virus-related liver disease. After 12 weeks, 66.6%, 55.5% and 11.1% of the patients showed a Psoriasis Assessment and Severity Index response of 50%, 75% and 90%, respectively. After 20 weeks, these levels had increased to 75%, 62.5% and 37.5%, respectively. After 12 weeks, the Psoriasis Global Assessment (PGA) score was clear or almost clear in 33.3% of the patients. By week 20, this clearance rate had almost doubled (62.5%). In two patients, the treatment was prolonged for 52 weeks, with a sustained response. One patient presented nonspecific colitis and died as a result of in-hospital pneumonia; any implication of adalimumab in the death is not clear. No other serious adverse effects were observed. In this series adalimumab was found to be effective for psoriasis refractory to other treatments including infliximab and etanercept.