Identification of nail features associated with psoriasis severity

There are no detailed studies of the prevalence of nail psoriasis and clinical characteristics of psoriatic nail involvement, including nail features associated with disease severity. Therefore, we designed a study to investigate the prevalence and characteristics of psoriatic nail involvement in patients with psoriasis and determine the relationship between psoriatic nail features and severity of nail psoriasis and cutaneous psoriasis. The Nail Psoriasis Severity Index (NAPSI) was used for evaluation of the severity of nail lesions. The presence of nail fold psoriasis (NFP) was also assessed. The severity of psoriasis was evaluated by calculating the Psoriasis Area and Severity Index (PASI). As a result, the prevalence of nail psoriasis was 85.5%. Pitting was the most common clinical feature (55.6%). The severity of nail psoriasis was not affected by medical parameters, although patients with localized pustular psoriasis tended to have more severe nail psoriasis than did those with chronic plaque psoriasis. When comparing the mean NAPSI and the mean PASI according to nail lesions, we found that subungual hyperkeratosis (SH) and NFP were significantly associated with the severity of both nail psoriasis and cutaneous psoriasis. Psoriatic nail changes were most common in the first digit. Conclusively, the majority of patients with psoriasis had psoriatic nail involvement, and Koebner's response seems to be closely related to the induction of nail psoriasis. To limit progression of the disease, psoriatic patients with SH or NFP should be examined thoroughly because those clinical features reflect the levels of severity of both nail and cutaneous psoriasis.     

A randomized clinical trial in psoriasis: synchronous balneophototherapy with bathing in Dead Sea salt solution plus narrowband UVB vs. narrowband UVB alone (TOMESA‐study group)

Background Synchronous balneophototherapy (sBPT) simulates treatment conditions at the Dead Sea for outpatient use. In the past, sBPT proved to be an effective treatment for psoriasis. However, there is a lack of sufficiently large randomized controlled clinical trials evaluating the additional benefit of sBPT compared with ultraviolet B (UVB) monotherapy. Objectives The purpose of this study was to compare the effectiveness and safety of sBPT with UVB phototherapy (PT) alone in a randomized controlled effectiveness study. Methods In this phase III, multicentre effectiveness study, 367 patients with moderate to severe psoriasis were randomly allocated in a 1 : 1 ratio to receive either sBPT consisting of narrowband UVB PT with 311 nm and synchronous bathing in 10% Dead Sea salt solution or PT with 311 nm alone. Primary endpoint, analysed on an intention‐to‐treat basis (n = 356), was the relative improvement of the Psoriasis Area and Severity Index (PASI) from baseline to end of treatment (35 sessions or clearance). Sample size calculation aimed at the detection of superiority of at least 10%. Results Median PASI values were comparable at baseline (sBPT: 15.1, interquartile range: 10.9–24.3; PT: 15.3, interquartile range: 10.0–23.7). A clinically relevant and statistically significant difference of 49.5% between sBPT and PT could be proven at the end of the therapy phase (P < 0.001; Wilcoxon–Mann–Whitney test). Exploratory testing showed a statistically significant superiority of sBPT after 6 months. Conclusions In routine clinical practice, sBPT is superior to PT alone after 35 treatment sessions and a follow‐up of 6 months. Both treatments demonstrated to be safe.     

The Salford Psoriasis Index: an holistic measure of psoriasis severity

We have developed, tested and validated a new scoring system for psoriasis: the Salford Psoriasis Index (SPI). The SPI incorporates the current clinical extent of psoriasis based on the Psoriasis Area and Severity Index (PASI), a score indicating psychosocial disability, and past severity based on treatment history. The resultant three-figure SPI (signs, psychosocial disability, interventions) is a similar paradigm to the TNM (tumour, nodes, metastasis) classification used for cancer staging. The first figure transforms the PASI into a number from 0 to 10 reflecting extent of psoriasis. The second assesses the psychosocial impact of psoriasis on each patient using a 0-10 visual analogue scale. The third figure reflects historical severity of disease as judged by the need for systemic treatment, admission to hospital and number of episodes of erythroderma. The SPI was prospectively employed in assessing 150 consecutive patients with psoriasis. Furthermore, in a separate cohort of 100 patients we tested the Psychosocial Impact Score against a recognized self-report psoriasis-specific measure, the Psoriasis Disability Index. There was a strong correlation between the two (r = 0.59, P < 0.001). However, the Psychosocial Impact Score correlated poorly with clinical extent scores such as the PASI (r = 0.28, P < 0.05) and the Self-administered PASI in 72 patients tested (r = 0.19, P = 0.1). There was a high correlation between all six observers in 20 patients for both PASI (r = 0.71; 95% confidence interval, CI 0.51-0.86) and the Extent Score (r = 0.70; 95% CI 0. 56-0.89). We believe that the SPI will be more relevant to real-life categorization of psoriasis severity in that it takes an holistic approach based not only on physician assessment but also psychological disability and treatment resistance.     

Efficacious treatment of psoriasis with low‐dose and intermittent cyclosporin microemulsion therapy

Cyclosporin is used for moderate to severe psoriasis and improves not only the skin lesions but also quality of life of the patients. To improve its safe use, we evaluated a low‐dose, intermittent regimen of cyclosporin in the treatment of psoriasis vulgaris. Seventy‐three patients received approximately 2.5 mg/kg per day of cyclosporin microemulsion twice daily before breakfast and dinner for 2–12 weeks until 75% reduction was achieved in Psoriasis Area and Severity Index (PASI) score. When the skin lesions relapsed after cessation of cyclosporin and showed less than 50% reduction from baseline in PASI score, cyclosporin was restarted. This cessation and restart cycle was repeated if necessary. Treatment outcomes were assessed at 12, 48 and 96 weeks after initiation of the therapy. The initial dose of cyclosporin was 2.32 ± 0.27 (standard deviation [SD]) mg/kg per day. At baseline, the mean PASI score was 11.3 ± 5.3 (SD). An average of 49.8 ± 23.8 (SD) days of the therapy achieved PASI 75% reduction. In 20 of 73 patients, the second course of cyclosporin was required. The mean interval between the first and second course was 94 days. An average of 60.8 ± 26.9 days was required to achieve PASI 75% reduction in the second course, which was not significantly longer than that in the first course. Only six patients required cyclosporin for 96 weeks. The adverse effects included one case of hypertension. Our study suggests that low‐dose, intermittent cyclosporin microemulsion is efficacious for the treatment of moderate to severe psoriasis.     

Plasma trough levels of adalimumab and infliximab in terms of clinical efficacy during the treatment of psoriasis

We examined the relation between adalimumab and infliximab plasma trough levels, anti‐adalimumab and anti‐infliximab antibody formation. We analyzed plasma from 32 adalimumab‐treated and 20 infliximab‐treated psoriasis patients for evaluating trough levels of each drug. The presence of anti‐adalimumab and anti‐infliximab antibodies was analyzed and the severity of psoriasis was evaluated. At week 28, 25 out of 32 and at week 48, 21 out of 30 adalimumab‐treated patients maintained as more than PASI 75. At week 28, 12 out of 20 and at week 48, nine out of 18 infliximab‐treated patients were evaluated as more than PASI 75. In patients treated with 40 mg adalimumab every other week, the mean trough level was 7.62 μg/mL (range, 0.05–10.6) at week 48. In patients treated with 80 mg adalimumab every other week, the mean trough level was 8.61 μg/mL (range, 0.08–13.5) at week 48. Mean trough level of infliximab‐treated cases (4.1–5.2 mg/kg; mean, 4.6) was 4.64 μg/mL (range, 0.03–16.9) at week 48. Anti‐adalimumab antibody was detected in five out of 32 cases and anti‐infliximab antibody was detected in six out of 20 cases, respectively, at weeks 24 and 48. The optimal cut‐off values of adalimumab and infliximab concentration for more than PASI 75 were more than 7.84 μg/mL and more than 0.92 μg/mL, respectively. The trough levels of adalimumab and infliximab in psoriasis patients were positively associated with clinical response and were significantly lower in cases having anti‐adalimumab or anti‐infliximab antibodies.     

Facial Psoriasis Log‐based Area and Severity Index: A valid and reliable severity measurement method detecting improvement of facial psoriasis in clinical practice settings

Facial psoriasis is often observed in moderate to severe degrees of psoriasis. While we previously demonstrated construct validity of the facial Psoriasis Log‐based Area and Severity Index (fPLASI) system for the cross‐sectional evaluation of facial psoriasis, its reliability and accuracy to detect clinical improvement has not been confirmed yet. The aim of this study is to analyze whether the fPLASI properly represents the range of improvement for facial psoriasis compared with the existing facial Psoriasis Area and Severity Index (fPASI) after receiving systemic treatments in clinical practice settings. The changing severity of facial psoriasis for 118 patients was calculated by the scales of fPASI and fPLASI between two time points after systemic treatments. Then, percentage changes (ΔfPASI and ΔfPLASI) were analyzed from the perspective of both the Physician's Global Assessment of effectiveness (PGA) and patients’ Subjective Global Assessment (SGA). As a result, the distribution of the fPASI was more heavily clustered around the low score range compared with the fPLASI at both first and second visits. Linear regression analysis between ΔfPASI and ΔfPLASI shows that the correlation coefficient was 0.94, and ΔfPLASI represented greater percentage changes than ΔfPASI. Remarkably, degrees of clinical improvement measured by the PGA matched better with ΔfPLASI, while ΔfPASI underestimated clinical improvements compared with ΔfPLASI from treatment‐responding groups by the PGA and SGA. In conclusion, the fPLASI represented clinical improvement of facial psoriasis with more sensitivity and reliability compared with the fPASI. Therefore, the PLASI system would be a viable severity measurement method for facial psoriasis in clinical practice.     

Serum leptin levels, skin leptin and leptin receptor expression in psoriasis

Background Recent studies support the relation of psoriasis with obesity and cardiovascular disease. Leptin, a peptide hormone secreted predominantly from adipose tissue, is involved in the regulation of energy intake and expenditure. Recently, it has been shown to have several immunological effects including induction of proinflammatory cytokine production. Objectives To investigate the possible role of leptin in psoriasis pathogenesis. Methods Forty‐three patients with psoriasis, 10 diseased and 10 healthy controls with normal body mass index were included. Serum fasting leptin levels of the study group were examined by enzyme‐linked immunosorbent assay. Tissue leptin and leptin receptor expression of both patients and controls were investigated by immunohistochemistry. Results Serum leptin levels, tissue leptin and leptin receptor expression were significantly higher in patients with severe psoriasis than patients with mild–moderate psoriasis and controls (P < 0·05). Serum leptin levels showed a positive correlation with Psoriasis Area and Severity Index and involved body surface area in patients with psoriasis. In addition, serum leptin levels, tissue leptin and leptin receptor expression showed a positive correlation with disease duration in patients with psoriasis (P < 0·01, r = 0·979; P < 0·01, r = 0·691; P < 0·01, r = 0·428, respectively). Conclusions We assume that leptin might serve as a marker of severity in psoriasis and also may be a pathogenetic cofactor contributing to chronicity of the disease. Consequently, its role in obesity and cardiovascular disease in patients with psoriasis deserves to be studied. In addition, drugs targeting the proinflammatory effects of leptin may be a new adjuvant therapeutic approach in psoriasis.     

Patients' perspective of pruritus in chronic plaque psoriasis: a questionnaire-based study

Background  Pruritus in psoriasis patients has not been regarded as a major symptom.
Objective  To study the pattern of pruritus in chronic plaque psoriasis.
Methods  A questionnaire was sent out to 109 patients with a diagnosis of chronic plaque psoriasis, who attended our outpatient departments during the period of January 2006 to January 2007.
Results  Out of 109 patients, 80 patients (74%) answered the questionnaire. Pruritus was found in 80% of the patients, with an intensity of 5.2 ± 2.6 (±SD) using a visual analogue scale (0–10). The frequency and intensity of pruritus were higher in women. Lower leg and scalp were reported to be the most commonly affected sites. Major aggravating factors for pruritus were stress and dryness of skin. Sun, sleep and vacation could relieve pruritus. The most common antipruritic treatments used by the patients were topical steroids, topical vitamin D, emollients and ultraviolet light therapy, whereas antihistamines were used by a small number of patients. Mood, concentration and sleep were negatively affected by pruritus.
Conclusion  Pruritus is a common symptom in patients with chronic plaque psoriasis.     

The efficacy of narrowband ultraviolet B phototherapy in psoriasis using objective and subjective outcome measures

The efficacy of narrowband ultraviolet B (UVB) was assessed in 100 consecutive patients with psoriasis by quantifying disease severity using objective (Psoriasis Area and Severity Index, PASI and Dermatologists Global Assessment, DGA) and subjective (Psoriasis Disability Index, PDI) measures. The median pretreatment PASI, DGA and PDI were 5.7 (interquartile range, IQR 4.5-8.35), 7 (IQR 6-9) and 42 (IQR 29-63.5), respectively. At 3 month follow-up, the PASI, DGA and PDI had fallen to 2.7 (IQR 1.1-3.5), 3 (IQR 2-5) and 30 (IQR 21-50.5), respectively (P < 0.001). A small group of patients continued to score highly on their PDI despite being clinically clear or having minimal disease, possibly representing chronic disability behaviour. Patients exhibiting this may require more intensive supervision. In most patients, symptoms of itch and pain improved or disappeared (70% and 75%, respectively). Side-effects were reported in 18%. Narrowband UVB phototherapy is safe and effective for psoriasis. Symptoms and subjective quality of life measures improved significantly. Both objective and subjective measures should be used when evaluating the efficacy of a treatment for psoriasis.     

Current severe psoriasis and the rule of tens

This review addresses the problems of defining severity of psoriasis. Concepts of severity depend on the timescale perspective from which judgement is made. Measurement needs to include assessment of signs, impact on the patient's life and the history of the disease. The concept of severity in relationship to quality of life measurement scores has been defined, so it is now possible to postulate a standard, easily remembered concept to help define 'severe psoriasis' in the clinic. The proposed Rule of Tens for current severe psoriasis from the clinician's viewpoint is: 'Current Severe Psoriasis = Body Surface Area involved > 10% or Psoriasis Area and Severity Index score > 10 or Dermatology Life Quality Index score > 10'.     

A study examining inter-rater and intrarater reliability of a novel instrument for assessment of psoriasis: the Copenhagen Psoriasis Severity Index

Background There is a perceived need for a better method for clinical assessment of the severity of psoriasis vulgaris. The most frequently used system is the Psoriasis Area and Severity Index (PASI), which has significant disadvantages, including the requirement for assessment of the percentage of skin affected, an inability to separate milder cases, and a lack of linearity. The Copenhagen Psoriasis Severity Index (CoPSI) is a novel approach which comprises assessment of three signs: erythema, plaque thickness and scaling, each on a four‐point scale (0, none; 1, mild; 2, moderate; 3, severe), at each of 10 sites: face, scalp, upper limbs (excluding hands and wrists), hands and wrists, chest and abdomen, back, buttocks and sacral area, genitalia, lower limbs (excluding feet and ankles), feet and ankles. Objectives To evaluate the inter‐rater and intrarater reliability of the CoPSI and to provide comparative data from the PASI and a Physician’s Global Assessment (PGA) used in recent clinical trials on psoriasis vulgaris. Methods On the day before the study, 14 dermatologists (raters) with an interest in psoriasis participated in a detailed training session and discussion (2·5 h) on use of the scales. On the study day, each rater evaluated 16 adults with chronic plaque psoriasis in the morning and again in the afternoon. Raters were randomly assigned to assess subjects using the scales in a specific sequence, either PGA, CoPSI, PASI or PGA, PASI, CoPSI. Each rater used one sequence in the morning and the other in the afternoon. The primary endpoint was the inter‐rater and intrarater reliability as determined by intraclass correlation coefficients (ICCs). Results All three scales demonstrated ‘substantial’ (a priori defined as ICC > 80%) intrarater reliability. The inter‐rater reliability for each of the CoPSI and PASI was also ‘substantial’ and for the PGA was ‘moderate’ (ICC 61%). The CoPSI was better at distinguishing between milder cases. Conclusions The CoPSI and the PASI both provided reproducible psoriasis severity assessments. In terms of both intrarater and inter‐rater reliability values, the CoPSI and the PASI are superior to the PGA. The CoPSI may overcome several of the problems associated with the PASI. In particular, the CoPSI avoids the need to estimate a percentage of skin involved, is able to separate milder cases where the PASI lacks sensitivity, and is also more linear and simpler. The CoPSI also incorporates more meaningful weighting of different anatomical areas.     

Assessment of depression in subjects with psoriasis vulgaris and lichen planus

AIM: The aim of this study was to investigate the frequency of depressive symptoms in psoriasis vulgaris and lichen planus and to evaluate the relationship between the Beck depression scores and the Psoriasis Area and Severity Index (PASI) scores of subjects with psoriasis vulgaris. SUBJECTS: The study involved 120 subjects attending the dermatology clinic of Izmir Ataturk Training Hospital (Izmir, Turkey) and comprised 50 subjects with psoriasis vulgaris, 30 with lichen planus and 40 healthy control subjects. RESULTS: Subjects with psoriasis vulgaris, lichen planus and controls had depression scores of 58%, 53% and 20%, respectively. The Beck depression scores of patients with psoriasis vulgaris were significantly higher than those of the control group. The PASI scores showed a correlation with Beck depression scores. Smoking and drinking were very common in subjects with psoriasis vulgaris. There was no correlation between the duration of illness and depressive symptoms. CONCLUSIONS: This study confirms the importance of depressive symptoms in two common dermatological diseases. It is important to recognize this association as it affects both clinical outlook and response to treatment.     

Apremilast,an oral phosphodiesterase 4 inhibitor,in the treatment of Japanese patients with moderate to severe plaque psoriasis: Efficacy,safety and tolerability results from a phase 2b randomized controlled trial

Apremilast, an oral, small‐molecule phosphodiesterase 4 inhibitor, works intracellularly within immune cells to regulate inflammatory mediators. This phase 2b randomized, placebo‐controlled study evaluated efficacy and safety of apremilast among Japanese patients with moderate to severe plaque psoriasis. In total, 254 patients were randomized to placebo, apremilast 20 mg b.i.d. (apremilast 20) or apremilast 30 mg b.i.d. (apremilast 30) through week 16; thereafter, all placebo patients were re‐randomized to apremilast 20 or 30 through week 68. Efficacy assessments included achievement of 75% or more reduction from baseline in Psoriasis Area and Severity Index score (PASI‐75; primary) and achievement of static Physician Global Assessment (sPGA; secondary) score of 0 (clear) or 1 (minimal) at week 16. Safety was assessed through week 68. At week 16, PASI‐75 response rates were 7.1% (placebo), 23.5% (apremilast 20; P = 0.0032 vs placebo) and 28.2% (apremilast 30; P = 0.0003 vs placebo); sPGA response rates (score of 0 or 1) were 8.8% (placebo), 23.9% (apremilast 20; P = 0.0165 vs placebo) and 29.6% (apremilast 30; P = 0.0020 vs placebo). Responses were maintained with apremilast through week 68. Most common adverse events (AEs) with placebo, apremilast 20 and apremilast 30 (0–16 weeks) were nasopharyngitis (8.3%, 11.8%, 11.8%), diarrhea (1.2%, 8.2%, 9.4%), and abdominal discomfort (1.2%, 1.2%, 7.1%), respectively. Exposure‐adjusted incidence of these AEs did not increase with continued apremilast treatment (up to 68 weeks). Apremilast demonstrated efficacy and safety in Japanese patients with moderate to severe plaque psoriasis through 68 weeks that was generally consistent with prior studies.     

Folic acid supplementation during treatment of psoriasis with methotrexate: a randomized, double-blind, placebo-controlled trial

BACKGROUND: The value of folate supplementation in methotrexate (MTX)-treated patients remains controversial. OBJECTIVES: To determine the effect of folic acid (FA) on the efficacy of MTX and the frequency of side-effects associated with MTX therapy. METHODS: A 12-week double-blind clinical trial was conducted in patients with psoriasis stable on their long-term MTX doses but not receiving FA. They were randomized into two arms of either FA 5 mg or placebo daily. MTX doses were not changed throughout the study. Patients were monitored every 3 weeks by the same observer. Assessments included Psoriasis Area and Severity Index (PASI), a visual analogue scale (VAS) of patients' perception of their psoriasis severity and the Dermatology Life Quality Index (DLQI). Adverse events were systematically recorded. Haematological and biochemical monitoring was performed. RESULTS: Twenty-two patients with psoriasis were recruited. Age, sex and weekly MTX doses were similar in both groups. All 22 patients completed the study. The mean PASI in the FA group increased from 6.4 at baseline to 10.8 at 12 weeks. In the placebo group the mean PASI fell from 9.8 at baseline to 9.2 at 12 weeks. The mean change from baseline in the FA group was 4.4 vs. -0.6 in the placebo group (P < 0.05). Similar trends were observed in the changes in VAS and in the DLQI and differences between the groups were significant for both these parameters (P < 0.05). Few adverse effects were reported. CONCLUSIONS: This study suggests that supplementation with FA during long-term MTX treatment reduces the efficacy of MTX in the control of psoriasis. Due to the relatively small sample size and short duration of this study, no conclusions can be drawn regarding the possibility that FA may reduce the side-effects of MTX.