Efficacy of oral methotrexate (MTX) monotherapy vs oral MTX plus narrowband ultraviolet light B phototherapy in palmoplantar psoriasis

Palmoplantar psoriasis (PPP) is a chronic, inflammatory dermatosis of the palms and/or soles with significant morbidity. It is notoriously difficult to treat and unresponsive to traditional topical agents. We aim to compare the effect of oral methotrexate (MTX) monotherapy vs MTX plus narrowband ultraviolet light B (NB‐UVB) in the treatment of recalcitrant PPP. This was a comparative clinical trial involving 90 patients of PPP. Eligible patients were randomly assigned to one of the two treatment groups. We aim patients in group A received 10 mg oral MTX weekly, and patients in group B received oral MTX 10 mg weekly and NB‐UVB sessions twice weekly for 12 weeks. There was a statistically significant difference in reduction of modified PPP Area Severity Index (m‐PPPASI) of patients in MTX plus NB‐UVB at week 12. The mean m‐PPPASI at week 12 was 3.66 ± 2.11 in MTX plus NB‐UVB group and 6.51 ± 2.04 in MTX only group (P < .001). Marked improvement (m‐PPPASI 75) was achieved in 20 (44.44%) patients in MTX plus NB‐UVB group compared with 6 (13.3%) in MTX monotherapy group (P < .001). Combination of MTX and NB‐UVB phototherapy helps to attain a better clinical response (reduction in m‐PPPASI score) than MTX monotherapy in the treatment of recalcitrant PPP.     

Efficacy and safety of mycophenolate mofetil vs. methotrexate for the treatment of chronic plaque psoriasis

Background Methotrexate (MTX) is a well‐known systemic drug for moderate to severe chronic plaque psoriasis. Recently, mycophenolate mofetil (MMF) has been recommended for psoriasis. Objective To compare the efficacy and safety of MMF vs. MTX for the treatment of chronic plaque psoriasis. Methods Thirty‐eight consecutive patients with Psoriasis Area and Severity Index (PASI) >10 were randomly assigned for 12 weeks of treatment with either MTX (18 patients; initial dose, 7.5 mg/week) or MMF (20 patients; dose; 2 g/day) and were followed for 12 weeks after discontinuing the treatment. The differences between the two groups were analysed at the end of treatment and follow‐up comparing with baseline values. Results After 12 weeks of treatment, the mean ± SD score for the PASI decreased from 16.46 ± 5.29 at baseline to 3.17 ± 2.35 among 15 patients treated with MTX, whereas the score decreased from 17.43 ± 7.42 to 3.97 ± 5.95 among 17 patients treated with MMF (P > 0.05). Twelve weeks after discontinuing the treatment, the scores were 4.77 ± 3.52 and 5.94 ± 4.27, respectively (P > 0.05). PASI ‐75 were achieved in 58.8% of patients in MMF group and 73.3% in MTX group (P > 0.05). Three months after discontinuing the treatment, PASI‐75 remained in 33.3% of patients in MMF and 53.3% of MTX group (P > 0.05). Both drugs were well tolerated and side‐effects were minor and transient. Conclusions No significant differences in efficacy were found between MTX and MMF groups. MMF may represent a good alternative for the treatment of psoriasis in patients who are unable to take MTX or other available drugs due to contraindication or toxicity.     

Subcutaneous methotrexate versus oral form for the treatment and prophylaxis of chronic plaque psoriasis

Psoriasis is a common inflammatory skin disorder with complex pathomechanisms. Methotrexate (MTX) is an antiproliferative and immunomodulating agent that control psoriasis. The aim of this study is to compare the efficacy of MTX and tolerability to MTX by oral route versus subcutaneous (SC) route. Twenty‐eight cases were divided into two equal groups: Group I received a weekly dose of oral MTX and Group II received a weekly dose of SC MTX for 12 weeks. The starting dose was 7.5–10 mg and increased gradually by 2.5 mg every month till reaching 12.5–15 mg/week. Patients' clinical responses were evaluated according to Psoriasis Area and Severity Index (PASI) score. Results suggest that Group I patients showed reduction in PASI score of mean ± SD from 19 ± 7.4 before treatment to 11.2 ± 6.29 after treatment while Group II patients showed reduction from 23.4 ± 14.7 before treatment to 2.55 ± 2.6 after treatment with highly statistically significant difference between both groups. Clinical improvement was complete in 7.1% of Group I versus 57.1% of Group II. In conclusion, SC MTX has higher efficacy with lesser adverse effects and lower relapse rate when compared to oral form given by the same dose during the same duration.     

A pilot study of pharmacokinetically guided dosing of oral methotrexate in the initial phase of psoriasis treatment

Background Clinical studies of low‐dose oral methotrexate (MTX) in the treatment of psoriasis and rheumatoid arthritis document a large interpatient variability in the pharmacokinetics of MTX, including its polyglutamates (MTXPGs) in erythrocytes (RBC). This can be a factor contributing to the variability of therapeutic and toxic effects. Aim This pilot trial aimed to investigate the MTXPG concentrations in RBC as well as their relation to therapeutic and adverse effects during the initial 4 months of pharmacokinetically guided therapy with a divided‐dose schedule (three doses of MTX separated by 12‐h intervals once a week). Subjects and methods Sixteen psoriatic patients (4 men and 12 women; mean age, 53 years; range, 28–69 years) with moderate‐to‐severe chronic plaque psoriasis [mean Psoriasis Area and Severity Index (PASI) = 24; range, 9–42] were enrolled in the study. Concentrations of plasma MTX and that of MTXPGs in RBC were assayed using liquid chromatography methods. The area under the concentration–time curve of plasma MTX in the interval 0–8 h post‐dose (AUC_0–8 h) was measured after a test bolus dose of 10 mg, and the starting weekly dose was individualized in order to achieve the target AUC_0–8 h of 1800 nmol·h/L. The PASI, biochemistry, and haematology tests and MTXPGs levels in RBC were evaluated at baseline and at 4‐week intervals. Results The AUC_0–8 h achieved 1360 ± 425 nmol·h/L (mean ± SD: range, 778–2400 nmol·h/L). The mean (range) of individualized doses was 14.5 mg/week (7.5–22.5 mg). The mean (SD) steady‐state concentration of total MTXPGs observed between days 85 to 110 reached 113 (34.6) nmol/L (range, 66.1–174 nmol/L). The PASI decreased from 24·0 ± 8.0 (mean ± SD) at baseline to 8.0 ± 6.1 at day 110 (P < 0.001). Thirteen patients (87%) achieved a greater than 50% improvement in baseline PASI, and seven (47%) experienced a greater than 75% improvement. There was no relationship between the percent improvement from baseline PASI and the steady‐state concentration of MTXPGs in RBC. All patients tolerated MTX well. Throughout the study period, there was a continuous increasing trend in the geometric mean values of the mean corpuscular volume from 92.6 to 96.4 fL (P < 0.001) and of plasma homocysteine from 9.5 to 12.3 µmol/L (P < 0.005). The geometric mean serum alanine aminotransferase (ALT) activity slightly increased from 0.49 to 0.80 µkat/L (P < 0.05). However, only two patients had the ALT activity transiently elevated above twice the upper limit of normal. Conclusion Results of this pilot trial show that the steady‐state levels of MTXPGs in RBC vary less than threefold between patients and did not correlate with the change in PASI observed after 4 months of therapy with an individualised weekly dose of MTX. Whether pharmacokinetically guided dosing can improve the results of psoriasis therapy with MTX should be prospectively tested in large controlled studies.     

Algorithm to select optimal systemic anti‐psoriatic drugs in relation with patients' Psoriasis Area and Severity Index score for plaque psoriasis

This study sought to develop a therapeutic algorithm for selecting the optimal systemic drugs to treat moderate to severe psoriasis, based on the patient's Psoriasis Area Severity Index (PASI) score. Data from 191 patients undergoing treatment for plaque psoriasis were retrospectively analyzed. Pre‐ and post‐treatment PASI scores were compared across patients treated with acitretin of retinoic acid (RA; n = 95), methotrexate (MTX; n = 41) or cyclosporin A (CsA; n = 55). The PASI score improvement was examined at weeks 4 (primary end‐point) and 12 (secondary end‐point). MTX and CsA had a higher global therapeutic efficacy, with more patients exhibiting a marked improvement (≥75% improvement in PASI [PASI 75]) at week 12 with MTX (56.1%, P = 0.028) and CsA (54.5%, P = 0.025) than RA (35.8%). Multivariate analysis adjusting for confounders produced consistent results (P = 0.026). For patients with severe psoriasis (PASI >12), the PASI 75 response was higher with CsA (55.6%) than RA (31.5%) (P = 0.023) at week 4 and higher with MTX (57.1%, P = 0.029) and CsA (61.5%, P = 0.017) than RA (21.7%) at week 12. Because RA is a standard systemic drug, the RA group was divided into two subgroups based on the PASI 50 response at week 12. Marked or moderate improvement (PASI ≥50) with RA was observed in patients with a pretreatment PASI score less than 14. Thus, oral RA is recommended as a first‐line drug for patients with PASI of less than 14, and MTX or CsA are recommended for patients with PASI of 14 or more.     

Efficacy and safety of systemic methotrexate in two fixed doses of 10 mg or 25 mg orally once weekly in adult patients with severe plaque-type psoriasis: a prospective, randomized, double-blind, dose-ranging study

Background. Methotrexate (MTX) is the ‘gold‐standard’ drug for the treatment of severe psoriasis. In the absence of any consensus on an optimum dose of MTX for psoriasis, there is wide variation in prescribing patterns between dermatologists, resulting in variable or delayed therapeutic effects. Aim. To identify the most effective fixed single weekly dose of oral MTX with acceptable side‐effects in the treatment of severe plaque‐type psoriasis. Methods. This was a prospective, randomized, double‐blind, parallel‐group, dose‐ranging study, which enrolled 60 patients of both genders (aged 18–62 years) with severe chronic plaque‐type psoriasis. Patients were randomly assigned to one of two groups: group A was treated with MTX 10 mg once weekly, and group B was treated with 25 mg MTX once weekly. The main outcome measure was change in Psoriasis Area and Severity Index (PASI) between the two groups from baseline to 12 weeks. Results. Of the 60 patients, 51 (85%) completed the 12‐week study. At the end of the study, 24 patients (92.3%) in the MTX 25 mg group had achieved a 75% reduction in PASI (PASI 75) from baseline, compared with 18 patients (72%) in the MTX 10 mg group (P > 0.05). Mean time in weeks to achieve PASI 75 was significantly shorter in the MTX 25 mg group (7.92 ± 1.91) than in the MTX 10 mg group (9.47 ± 2.29) (P < 0.05). In addition, 20 patients (69%) in the MTX 25 mg group achieved 100% reduction in PASI compared with 9 patients (30%) in the MTX 10 mg group within 12 weeks of the study period (P < 0.01). Adverse effects were generally mild, and were noted in 43.1% of the 51 patients who completed the study, with no significant difference in frequency between the two groups, although they were less severe in the 10 mg group. Conclusions. MTX 25 mg is an effective dose as monotherapy for the treatment of severe psoriasis, whereas the 10 mg dose is slow to act and less effective, but has a less severe side‐effect profile.     

Real world data from the use of secukinumab in the treatment of moderate‐to‐severe psoriasis,including scalp and palmoplantar psoriasis: A 104‐week clinical study

Several clinical studies demonstrated the safety and efficacy of the interleukin‐17 inhibitor secukinumab in the systemic treatment of moderate‐to‐severe psoriasis, as well as psoriatic arthritis (PsA) in adults, whereas real‐world data is limited. A single‐center clinical study was performed to evaluate in real‐world practice the efficacy of secukinumab up to Week 104 of treatment in moderate‐to‐severe chronic plaque psoriasis, including scalp and palmoplantar involvement, according to Physician Global Assessment (PGA), PASI75/90/100 and scalp, and palmoplantar PGA. Drug survival, the safety profile of secukinumab, and patient's quality of life were also assessed during a 2‐year observation period. Out of 83 patients included, 56.3% were biologic‐naïve, and 94% had scalp, 25.3% palmoplantar, and 43.9% joint involvement. At Week 16, PASI75/PASI90/PASI100 were observed in 83.8/70.0/46.3%, respectively. Scalp and palmoplantar PGA were rapidly improved, with 98.7 and 95.5%, respectively, reaching clear/almost clear skin at Week 16. After 104 weeks, drug survival was 74.5%. A significant improvement of the quality of life was observed. Biologic‐naïve patients without coexisting PsA benefited the most. Real‐world data demonstrated secukinumab efficacious in chronic plaque psoriasis, including specific locations such as scalp and palmoplantar psoriasis with a safety profile similar to that in clinical trials.     

Efficacy and safety of infliximab vs. methotrexate in patients with moderate-to-severe plaque psoriasis: results of an open-label, active-controlled, randomized trial (RESTORE1)

Background Infliximab is indicated for treatment of moderate‐to‐severe plaque psoriasis in adults whose disease cannot be controlled with other systemic therapies, including methotrexate (MTX). To date, no studies have directly compared the efficacy and safety of infliximab and MTX. Objectives To compare the efficacy and safety of infliximab vs. MTX in adults with moderate‐to‐severe plaque psoriasis. Methods MTX‐naïve patients (n = 868) were randomized 3 : 1 to receive infliximab 5 mg kg^?1 at weeks 0, 2, 6, 14 and 22 or MTX 15 mg weekly with a dose increase to 20 mg weekly at week 6 if the Psoriasis Area and Severity Index (PASI) response was < 25%. At week 16, patients with < PASI 50 response could switch treatment groups. The primary efficacy endpoint was PASI 75 response at week 16. Major secondary efficacy endpoints were PASI 75 response at week 26, and the proportion of patients achieving a Physician’s Global Assessment (PGA) score of cleared (0) or minimal (1) at weeks 16 and 26. Others included Dermatology Life Quality Index, 36‐Item Short Form Health Survey, and PGA, PASI 50, PASI 75 and PASI 90 responses over time. Results The primary endpoint was achieved by a significantly greater proportion of infliximab‐treated patients (508/653, 78%) than MTX‐treated patients (90/215, 42%; P < 0·001). Key secondary endpoints also were achieved by a greater proportion of infliximab‐treated patients. Similar responses were observed at week 26 in patients who switched from MTX to infliximab at week 16. Overall adverse event (AE) incidence was comparable between groups, but incidence of serious and severe AEs was slightly higher in the infliximab group. Conclusions Infliximab was well tolerated and more efficacious than MTX in patients with moderate‐to‐severe plaque psoriasis. Infliximab also was efficacious in patients who failed MTX and switched to infliximab.     

Weekly vs. daily administration of oral methotrexate (MTX) for generalized plaque psoriasis: a randomized controlled clinical trial

Methotrexate (MTX) treatment for psoriasis is most often administered weekly, because the drug has been considered more hepatotoxic when taken daily. However, some patients may tolerate smaller, more frequent doses better. Objective  To study the efficacy and toxicity of daily vs. weekly MTX. Patients and methods  In a randomized controlled trial, 101 patients with generalized plaque psoriasis received oral MTX 2.5 mg daily for 6 days (Group 1), and another 101 patients received oral MTX 15 mg weekly (Group 2) in three divided doses (every 8 hours during a 24‐hour period). Patients were followed monthly for 4 months as research participants, then for 1 year as part of their routine care. Complete blood counts, liver function tests, blood urea nitrogen, serum creatinine, urinalysis, and psoriasis area and severity index (PASI) scores were determined pre‐treatment and at the following intervals after starting treatment: 2 weeks, 4 weeks and monthly for a total of 4 months. Changes in PASI scores were classified into three categories: >75% improvement was considered significant; 25–75% moderate; and <25% poor. Results  Sixty Group 1 patients and 81 Group 2 patients showed a significant response (P‐value 0.001); 19 patients in Group 1 and 14 in Group 2 responded moderately; 22 patients in Group 1 and six patients from Group 2 responded poorly. Forty‐five patients in Group 1 and 33 in Group 2 developed transient increases in liver enzymes (P‐value 0.11). Nausea, headache, fatigue, and gastrointestinal upset were noted in four Group 1 patients and 30 Group 2 patients (P‐value 0.0001). Conclusion  Nausea, vomiting, headache, and fatigue were significantly less common side effects in our patients who received MTX daily, but liver enzyme abnormalities were less common, and clinical efficacy was greater in the patients who received MTX weekly.     

Methotrexate vs. fumaric acid esters in moderate‐to‐severe chronic plaque psoriasis: data registry report on the efficacy under daily life conditions

Objective To compare the clinical efficacy of methotrexate (MTX) vs. fumaric acid esters (FAE) in psoriasis treated under daily life conditions. Methods Data were extracted from a registry ( http://www.psoriasisregistry.at ) of 272 adult patients with moderate‐to‐severe chronic plaque psoriasis treated primarily with MTX (n = 72) or FAE (n = 200) between 2004 and 2011. Data from all patients, including those who did not complete at least 3 months of monotherapy, were included in an intention‐to‐treat (ITT) worst‐case analysis. Results Thirty of 72 (41.7%) patients treated with MTX and 85 of 200 (42.5%) patients treated with FAE discontinued early, mainly due to side‐effects or lack of response. Among patients who completed at least 3 months of treatment, the response to primary treatment with MTX vs. FAE did not differ significantly at any time point. In the ITT worst‐case analysis at month 3, complete remission rate, PASI90, PASI75 and PASI50 rates were 6%, 7%, 24% and 39% in MTX‐treated patients vs. 1%, 5%, 27% and 44% in FAE‐treated patients. Overall mean PASI reduction score improved significantly in response to primary MTX and FAE treatment (by 10.6% and 12.6%, respectively) between 3 and 6 months (P = 0.0005; exact Wilcoxon test), but not between 6 and 12 months (P = 0.16). A subset of 32 patients who did not respond satisfactorily to primary treatment with FAE responded better to subsequent MTX therapy (P < 0.0001; paired Wilcoxon test). Conclusions As shown by retrospective analysis, the primary efficacy of FAE was similar to that of MTX under daily life conditions.     

Tumor necrosis factor-α-converting enzyme as a potential mediator of the influence of smoking on the response to treatment with narrowband ultraviolet B in psoriasis patients

Purpose: The aim of the study was to analyze the relationship between smoking and the treatment with narrowband ultraviolet B (NB‐UVB) in psoriasis patients and to examine the role of the soluble tumor necrosis factor‐α receptor type one (sTNF‐R1) in plasma and that of TNF‐α‐converting enzyme (TACE) released from peripheral blood mononuclear cells (PBMC) in this relationship. Methods: The study has been conducted among 45 inpatients with plaque‐type psoriasis vulgaris and 36 inpatients with other chronic inflammatory skin disorders from similar social background (controls). Taking into account the number of cigarettes smoked daily and the duration of smoking, subjects were classified as mild, moderate and heavy smokers. The severity of psoriasis was assessed using psoriasis area and severity index (PASI) score, concentrations of sTNF‐R1 and TACE (expressed in ng/ml) – with quantitative sandwich enzyme immunoassays before (T₀) and after 20 NB‐UVB irradiations (T₂₀). Results: The pretreatment concentration of sTNF‐R1 was 2.55±0.17 in patients and 1.79±0.13 in controls (P<0.05) and that of TACE – 2.62±0.34 and 1.29±0.25, P<0.05, respectively. PASI score correlated with sTNF‐R1 and with TACE concentrations (R=0.40 and R=0.38, P<0.05, respectively). PASI score, sTNF‐R1 and TACE concentrations were similar in mild, moderate and in heavy smokers. PASI score and TACE concentration declined significantly after treatment in three groups; the lowest TACE concentration at T₂₀ was noticed in mild smokers, the highest in heavy smokers (0.86±0.26 and 1.91±0.20, P<0.05, respectively). The post‐treatment PASI score correlated with the intensity of smoking and with TACE concentration (R=0.50 and R=0.47, P<0.05, respectively). The strong correlation between the pretreatment TACE concentration and the treatment outcome was observed in heavy smokers (R=0.63, P<0.05). Conclusions: The baseline TACE concentration in PBMC may be of value in predicting the response to the treatment with NB‐UVB in smoking psoriasis patients. Smoking may adversely influence this treatment and TACE may be one of mediators in this influence.     

Efficacy and safety of ixekizumab treatment for Japanese patients with moderate to severe plaque psoriasis,erythrodermic psoriasis and generalized pustular psoriasis: Results from a 52‐week,open‐label,phase 3 study (UNCOVER‐J)

Psoriasis, a chronic, immune‐mediated skin disease characterized by red, scaly plaques, affects approximately 0.3% of the population in Japan. The aim of this open‐label study was to evaluate the long‐term efficacy and safety of ixekizumab, a humanized, anti‐interleukin‐17A monoclonal antibody, in Japanese patients with plaque psoriasis (n = 78, including 11 psoriatic arthritis), erythrodermic psoriasis (n = 8) and generalized pustular psoriasis (n = 5). Ixekizumab was administrated s.c. at baseline (week 0, 160 mg), from weeks 2 to 12 (80 mg every 2 weeks), and from weeks 16 to 52 (80 mg every 4 weeks). At week 52, 92.3% of patients with plaque psoriasis achieved Psoriasis Area and Severity Index (PASI) 75, 80.8% achieved PASI 90, 48.7% achieved PASI 100, and 52.6% had remission of plaques (by static Physician Global Assessment, sPGA [0]). Difficult to treat areas of psoriasis (nail or scalp) also responded to ixekizumab. All patients with psoriatic arthritis who were assessed (5/5) achieved an American College of Rheumatology 20 response. Most patients with erythrodermic psoriasis or generalized pustular psoriasis responded to ixekizumab and the clinical outcome was maintained over 52 weeks (75% and 60% of patients achieved sPGA [0, 1] at week 52, respectively). Mostly mild or moderate treatment‐emergent adverse events were reported by 79 of 91 patients; the most common were nasopharyngitis, eczema, seborrheic dermatitis, urticaria and injection site reactions. In conclusion, 52‐week ixekizumab treatment was efficacious and well tolerated in Japanese patients with plaque psoriasis. Efficacy was also observed in patients with erythrodermic psoriasis, generalized pustular psoriasis and psoriatic arthritis.     

Treatment of severe,recalcitrant, chronic plaque psoriasis with fumaric acid esters: a prospective study

Background Fumaric acid esters (FAE) are used in Germany as a first‐line systemic treatment for chronic plaque psoriasis, with proven efficacy and low toxicity. Their use in the U.K. is variable, and they remain unlicensed. Consequently, efficacy and safety data from U.K. patients is limited and their place in the psoriasis treatment armamentarium is unclear. Objectives To examine the efficacy and safety of FAE in a prospective cohort of U.K. patients with severe, treatment‐recalcitrant, chronic plaque psoriasis. Methods A single‐centre, open, nonrandomized, prospective study was performed in a regional referral centre for patients with severe psoriasis. Outcomes were measured by the Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), blood investigations and adverse events monitoring. Results Eighty patients were recruited. Fifty‐nine per cent were taking a concomitant oral antipsoriatic agent; 20% achieved a PASI‐50, 8% a PASI‐75 and 4% a PASI‐90 on intention‐to‐treat analysis at 3 months with an overall, statistically significant, reduction in PASI from 13·9 ± 9·0 to 11·3 ± 9·2 (P < 0·0001). At 3 months, lymphopenia was seen in 33% of the cohort with significantly lower counts in patients responsive to FAE (P = 0·008). In addition, by 3 months, 36% of concomitant antipsoriatic medication had been stopped and 25% of doses had been reduced without loss of disease control. Side‐effects (most commonly diarrhoea, abdominal pain and flushing) were reported by 74% of patients resulting in cessation of FAE in 36%. Conclusions FAE is a useful alternative treatment option in patients with severe, treatment‐resistant, chronic plaque psoriasis and can allow dose reduction, and subsequent cessation, of other, potentially more toxic agents.     

Efficacy and safety of ustekinumab treatment in elderly patients with psoriasis

The ratio of the elderly among psoriasis patients has been increasing. However, satisfactory long‐term management of psoriasis for the elderly is challenging because of the more frequent presence of comorbidities, and the higher risk of adverse events from systemic therapeutic agents than younger patients. The use of ustekinumab (UST) appears to be an appropriate systemic treatment because it is considered less likely to cause adverse events than other systemic treatments, as well as necessitating fewer hospital visits. Our retrospective study aimed to evaluate the efficacy and safety profile of UST in elderly patients with psoriasis. The study included 24 patients aged over 65 years (range, 65–88 years; mean, 73.1 years) with moderate to severe plaque psoriasis with impaired quality of life. Efficacy and safety were assessed over a 1‐year period using the Psoriasis Area and Severity Index (PASI) and the Dermatology Live Quality Index (DLQI). The efficacy was evaluated by the proportion of subjects who achieved ≥75% reduction in PASI score (PASI 75). PASI 75 responses were 56.5% at week 16, 59.1% at week 28, and 60.0% at week 52. None of the patients developed any serious infection during the 1‐year treatment. The mean DLQI score at weeks 0, 16, 28, and 52 was 7.8 ± 6.0, 2.5 ± 3.4, 1.4 ± 1.7, and 1.2 ± 1.7, respectively. UST showed sufficient efficacy for elderly patients with psoriasis without any serious infection over the 1‐year treatment. Our results suggest that UST is the preferable agent for the treatment of elderly patients with psoriasis.     

Balneotherapy with Chinese herbal medicine prolongs the remission period in patients with psoriasis vulgaris

This study aimed to evaluate whether the supplementary balneotherapy with Chinese herbal medicine (CHM) could facilitate the treatment of psoriasis vulgaris and thus be beneficial for long‐term remission from the symptoms. Two hundred psoriasis vulgaris patients with moderate‐to‐severe plaque psoriasis from January 2013 to June 2014 were evenly divided into two groups: the consolidated therapy group (CTG) and unconsolidated therapy group (UTG); the remission period of the two groups was compared. There was no significant difference in Psoriasis Area Severity Index (PASI) score between the two groups at the beginning and the end of the treatment. However, the average remission time in CTG was 10.99 months, which was significantly longer than that of 7.94 months in UTG (P = .001). After a correction of age, course of disease, skin type as well as PASI baseline value using a COX model, we found that the risk of recurrence of psoriasis vulgaris in UTG was higher than that in the CTG (P < .001). No adverse reactions were discovered when combing the two treatments together. The combined treatment of CHM balneotherapy and narrowband ultraviolet B could significantly prolong the remission time in patients with psoriasis vulgaris.     

Plasma homocysteine and folate levels in patients with chronic plaque psoriasis

Background Hyperhomocysteinaemia is a well‐known risk factor for cardiovascular diseases. Patients with severe chronic plaque psoriasis have a higher risk of death due to arterial and/or venous thrombosis. Objectives To investigate the relationship among plasma homocysteine and folate levels and severity of chronic plaque psoriasis in a selected cohort of patients with psoriasis without known risk factors for acquired hyperhomocysteinaemia. Methods We performed a case–control study in 40 patients with chronic plaque psoriasis and 30 age‐ and sex‐matched healthy controls. Cases and controls were selected excluding individuals with conditions or diseases associated with acquired hyperhomocysteinaemia, and were also asked to stop alcohol and coffee consumption for 1 week before blood sampling. The plasma levels of homocysteine and folic acid were measured and were correlated with the severity of psoriasis (Psoriasis Area and Severity Index, PASI). Results Patients with psoriasis had plasma homocysteine levels higher than controls (mean ± SD 16·0 ± 5·6 vs. 10·4 ± 4·7 μmol L^?1; P < 0·001). Conversely, folic acid levels were lower in patients with psoriasis compared with controls (mean ± SD 3·6 ± 1·7 vs. 6·5 ± 1·7 nmol L^?1; P < 0·001). Plasma homocysteine levels in patients with psoriasis correlated directly with disease severity (PASI) and inversely with folic acid levels. Plasma folic acid levels were inversely correlated with the PASI. No abnormalities of plasma vitamin B₆ and B₁₂ were found. Conclusions Patients with psoriasis may have a tendency to hyperhomocysteinaemia, which may predispose to higher cardiovascular risk. Dietary modification of this risk factor appears relevant to the global management of patients with moderate to severe psoriasis.     

Adalimumab for psoriasis: practical experience in a U.K. tertiary referral centre

Background There are few reports of the practical use of adalimumab outside a clinical trial setting and, to our knowledge, none from the U.K. Objectives We assessed the efficacy and safety of adalimumab in a cohort of patients with severe psoriasis attending a tertiary dermatology referral centre in the U.K. Methods A retrospective case‐note review was used to identify all patients initiated on adalimumab for psoriasis. Results Mean ± SD baseline Psoriasis Area and Severity Index (PASI) score was 24 ± 11 (range 9–54; n = 46). After 4 months’ treatment with adalimumab, 64% (29/45) of patients had achieved PASI 75 (75% decrease from baseline) while 80% (36/45) of patients met National Institute for Health and Clinical Excellence (NICE) criteria for continuation of treatment. The therapy was well tolerated. Importantly, 68% (21/31) of patients who had previously received another tumour necrosis factor‐α inhibitor met NICE criteria for continuation of treatment at 16 weeks. Conclusions In a cohort of U.K. patients with severe psoriasis, adalimumab has proved to be a significant addition to the expanding armamentarium of biologics for psoriasis. Pharmacovigilance, in the form of registries, is essential to assess the long‐term safety of such drugs.     

Management of long‐term therapy with biological drugs in psoriatic patients with latent tuberculosis infection in real life setting

Psoriatic patients with latent tuberculosis infection (LTBI) need a prophylaxis before starting a treatment with biological drugs. The aim of this study is to investigate the safety and efficacy of prophylaxis of LTBI in psoriatic patients receiving long‐term biological drugs. The study included 56 patients (42 male and 14 female) affected by moderate‐to‐severe psoriasis (mean PASI: 12.8 ± 6.9 SD) treated with anti‐TNF‐α and/or anti IL 12, 23 and/or anti‐CD11 drugs with a diagnosis of LTBI. LTBI diagnosis was based on tuberculin skin test and/or QuantiFERON TB Gold test positivity and chest X‐ray suggestive, without clinical, or microbiological evidence of active disease. All patients received prophylactic therapy for 9 months with isoniazid (INH) 300 mg/day, starting 3 weeks before the beginning of biological treatment. Fifty‐four patients completed prophylaxis with INH without any adverse events or intolerance; they continue the biological treatment without appearance of active tuberculosis. One patient developed tuberculosis pleurisy in course of treatment with etanercept. The infection has been treated and after a stable remission, treatment was restarted without tuberculosis reactivation. In this retrospective analysis, the prophylaxis of LTBI whit INH was effective and safe in longer follow‐up period.     

Effect of climate therapy at Gran Canaria on vitamin D production, blood glucose and lipids in patients with psoriasis

Background Climate therapy (heliotherapy) of psoriasis is an effective and natural treatment. Ultraviolet radiation (UVB) from the sun improves psoriasis and induces vitamin D₃ synthesis. Objective The aim of the study was to investigate the effect of climate therapy on vitamin D₃ synthesis, blood glucose, lipids and vitamin B12 in psoriasis patients. Methods Twenty Caucasian patients (6 women and 14 men; mean age, 47.2 years; range, 24–65) with moderate to severe psoriasis [mean Psoriasis Area and Severity Index (PASI) score 9.8; range, 3.8–18.8] received climate therapy at the Gran Canarias for 3 weeks. Blood samples were drawn before and after 15 days of sun exposure. In addition, the patients’ individual skin UV doses based on UV measurements were estimated. Results Sun exposure for 15 days lead to a 72.8% (± 18.0 SD) reduction in the PASI score in psoriasis patients. Although no direct correlation was observed between PASI score improvement and UVB dose, the sun exposure improved the vitamin D, lipid and carbohydrate status of the patients. The serum concentrations of 25‐hydroxyvitamin D [25(OH)D] increased from 57.2 ± 14.9 nmol/L before therapy to 104.5 ± 15.8 nmol/L (P < 0.0001) after 15 days of sun exposure; the serum levels of 1,25‐dihydroxyvitamin D [1,25(OH)₂D] increased from 146.5 ± 42.0 to 182.7 ± 59.1 pmol/L (P = 0.01); the ratio of low‐density lipoprotein cholesterol and high‐density lipoprotein cholesterol decreased from 2.4 to 1.9 (P < 0.001); and the haemoglobin A₁c (HbA₁c) levels decreased from 5.6 ± 1.7% to 5.1 ± 0.3% (P < 0.0001). Conclusion Climate therapy with sun exposure had a positive effect on psoriasis, vitamin D production, lipid and carbohydrate status.     

Combining etanercept and acitretin in the therapy of chronic plaque psoriasis: a 24-week, randomized, controlled, investigator-blinded pilot trial

Background Combination treatments may increase efficacy while reducing dosages and side‐effects of individual agents. No randomized controlled trials have been published combining biologics with conventional agents for psoriasis. Objectives To investigate the efficacy and safety of the association of acitretin and etanercept in the treatment of moderate to severe chronic plaque psoriasis. Methods A 24‐week, randomized, controlled, investigator‐blinded pilot trial was conducted. Sixty adult patients with moderate to severe chronic plaque psoriasis were randomized into three groups to receive etanercept 25 mg twice weekly subcutaneously, oral acitretin 0·4 mg kg^?1 daily or etanercept 25 mg once weekly plus acitretin 0·4 mg kg^?1 daily. The primary end point was a 75% or greater improvement in Psoriasis Area and Severity Index (PASI) from baseline (PASI 75) at week 24. Results At week 24, PASI 75 response was achieved by 10 of 22 patients in the etanercept group (45%), six of 20 in the acitretin group (30%) and eight of 18 (44%) in the group treated with etanercept plus acitretin (P = 0·001 for both etanercept groups compared with acitretin alone). A 50% or greater improvement from baseline in PASI was achieved by 15 of 22 (68%), 10 of 20 (50%) and 12 of 18 (67%) patients, respectively (P = 0·001). The safety profiles of the three groups were similar. Conclusions A combined therapeutic regimen with etanercept 25 mg once weekly and acitretin 0·4 mg kg^?1 daily is as effective as etanercept 25 mg twice weekly, and more effective than acitretin alone. Although larger studies are needed to confirm these results, the etanercept/acitretin association could offer several advantages in the therapy of moderate to severe chronic plaque psoriasis.