Treatment Of Plaque-type Psoriasis Research Articles

Effectiveness and tolerability of guselkumab in patients with psoriasis: A longitudinal Belgian retrospective multicenter study

To the Editor: We conducted the first Belgian multicentric observational study that investigated the long-term (up to week 88) effectiveness and tolerability of guselkumab in the treatment of plaque-type psoriasis. Guselkumab (Tremfya, Janssen Biotech, Inc) is indicated for the treatment of moderate to severe plaque psoriasis or active psoriatic arthritis and binds selectively to interleukin 23p19.

Comparing the topical preparations of Indigo naturalis from Chinese and Iranian origin in the treatment of plaque-type psoriasis: A preliminary randomized double-blind pilot study

IntroductionPsoriasis is an inflammatory and proliferative disease. Indigo naturalis is a blue herbal pigment extracted from Indigofera tinctoria and other plants. The purpose of this study was to compare Iranian ointment made of Indigofera tinctoria with Chinese ointment made of Indigo naturalis from China, and topical betamethasone on the severity of chronic plaque-type psoriasis. MethodsIn this preliminary randomized double-blind pilot study, patients with localized chronic plaque-type psoriasis were divided into three groups to receive either topical Iranian herbal ointment, Chinese herbal ointment, or betamethasone ointment twice a day for 8 weeks. ResultsAt the end of the 8th week of treatment, the mean PASI score in the three groups was 5.8 ± 3.13, 6.32 ± 2.85, 3.04 ± 2.23 for the Chinese, Iranian and betamethasone ointments respectively; and the mean PASI score change from baseline was statistically significant only in the topical betamethasone group (p = 0.0082). ConclusionThe Iranian herbal ointment used for psoriasis for 8 weeks caused a lower clinical response in comparison with topical betamethasone or the Chinese herbal ointment in the studied patients.

Comparative evaluation of Gracilaria algae 3% cream vs Clobetasol 0.05% cream in treatment of plaque type psoriasis: A randomized, split-body, triple-blinded clinical trial.

Gracilaria algae is red macro algae which has demonstrated considerable anti-inflammatory effects. Our objective was to compare the efficacy of Gracilaria algae topical cream 3% vs Clobetasol cream 0.05% in treatment of plaque-type psoriasis. Thirty adult patients with baseline modified Psoriasis Area and Severity Index (PASI) score ≤12 were randomized to receive either Clobetasol or Gracilaria algae cream on right or left-sided symmetric plaques once daily for 8 weeks and follow-up of 4 weeks. Modified PASI score, patient's satisfaction using VAS and global physician assessment score were assessed to evaluate clinical response. Thirty patients with 94 symmetrical psoriasis plaques were enrolled in this trial. The mean baseline modified PASI score of both sides was similar; however, at the end of trial, modified PASI score was reduced more on the sides treated with Gracilaria algae cream (0.80 ± 0.19% vs 0.63 ± 0.25%, P < .05). No significant difference was found regarding mean physician global assessment score between the two groups (P > .05). Patients' satisfaction was significantly higher in favor of algae cream only at week 8 of the intervention (P < .05). Gracilaria algae cream can be an effective and safe alternative of Clobetasol in the treatment of plaque type psoriasis.

Treatment of plaque-type psoriasis with oral CF101: Data from a phase II/III phase 2 clinical trial

Treatment of plaque-type psoriasis with oral CF101: Data from a phase II/III phase 2 clinical trial

Comparative Efficacy of Topical Calcipotriol (0.005%) Versus Topical Corticosteroid (Betamethasone 0.1%) in Treating Plaque Type Psoriasis

A clinical trial was carried out to compare the efficacy of topical calcipotriol (0.005%) and topical corticosteroid (betamethasone 0.1%) in the treatment of plaque type psoriasis. The study was conducted from January 2012 to August 2012 and patients of plaque type psoriasis attending outpatient department of Dermatology and Venereology, Bangabandhu Sheikh Mujib Medical University, Dhaka were the study population. Patients were divided into two groups, group A was treated with topical calcipotriol (0.005%) ointment and group B with topical corticosteroid (betamethasone 0.1%) ointment. The mean baseline PASI score was 6.7 ±4.5 and after 8 weeks, the mean PASI score was 2.0 ±1.4 for group A and mean baseline PASI score was 5.5 ±4.2 and after 8 weeks, the mean PASI score was 2.5 ±1.4 for group B. There was statistically significant reduction in PASI score from base line after 8 weeks of treatment in both treatment groups (p &lt; 0.001). After 8th week of treatment moderate response was 11(73.3%) in group A and 9(60%) in group B. Very good response was 4 (26.7%) in group B and 2 (13.3%) in group A and minimal response of treatment occurs equally 2 (13.3%) in group A and group B. In the light of the findings of the study we conclude that each of the treatment of calcipotriol(0.005%) and betamethasone (0.1%) is individually effective. Further multicenter, randomized, double-blind study should be conducted with large sample size.Medicine Today 2014 Vol.26(2): 88-94

Calcipotriol/betamethasone for the treatment of psoriasis: efficacy, safety, and patient acceptability.

BackgroundOne of the advances in the treatment of plaque-type psoriasis is combined local therapy with calcipotriol and betamethasone. To provide both ingredients in a two-compound product, efforts have been made to unite calcipotriol and betamethasone because they are usually inactivated when present in the same formulation. This aspect was resolved when carefully designed vehicle components were invented (gel and ointment). This article reviews the efficacy, safety, and patient acceptability of calcipotriol/betamethasone dipropionate.MethodsA literature search of all articles published until February 2015 was performed, including the largest medical databases. The search strategy for evaluating the main topics of this review – efficacy, safety, and patient acceptability – was defined before checking the publications.ResultsSeventy references were found and checked for relevance. For efficacy, the proportion of patients whose psoriasis improved was always significantly higher in the two-compound group compared to the group treated with the individual substances. In the context of safety, the fixed combination was generally associated with a lower risk of adverse events. In terms of patient acceptability, the fixed combination led to a significant improvement in quality of life. The two-compound product was more convenient to handle and time saving compared to former treatments.ConclusionCalcipotriol/betamethasone dipropionate in a fixed combination is an effective and well-tolerated medication in mild-to-moderate psoriasis of body and scalp and, in addition, is an evidence-based treatment modality.

Developing a Therapeutic Range of Adalimumab Serum Concentrations in Management of Psoriasis: A Step Toward Personalized Treatment.

Adalimumab has proven to be effective in suppressing psoriasis disease activity and is administered in a standard dose. To establish a therapeutic range for adalimumab trough levels in the treatment of plaque-type psoriasis, leading to a more personalized treatment. A multicenter, prospective, observational, daily practice cohort study conducted at an academic hospital with affiliated secondary care hospitals in Belgium (cohort 1) and 2 academic hospitals in the Netherlands (cohort 2). Both cohorts included adult patients treated with adalimumab for plaque-type psoriasis. Cohort 1 comprised 73 patients who were being treated with adalimumab for more than 24 weeks until 401 weeks. In cohort 2 (n = 62), serum samples were obtained between weeks 24 and 52 of treatment. Before the start of adalimumab therapy and at time of serum sampling, Psoriasis Area and Severity Index (PASI) scores were determined. Adalimumab trough level and PASI score at the time of serum sampling to determine the receiver-operator characteristics analyses and concentration effect curve. By means of receiver-operator characteristics analyses with an area under the curve of 0.756 (SD, 0.046; 95% CI, 0.666-0.847) and a sensitivity of 78% and a specificity of 70%, 3.51 mg/L was established as the lower margin for the therapeutic range. By means of a concentration effect curve, 7 mg/L was established as the upper margin. One-third of patients had an adalimumab trough concentration exceeding 7 mg/L. A therapeutic range of adalimumab trough levels of 3.51 mg/L to 7.00 mg/L, which corresponds to an optimal clinical effect, was identified. In one-third of patients, it was observed that trough concentrations exceeded the therapeutic window. Based on the established range, a therapeutic algorithm for adalimumab treatment for patients with psoriasis can be developed and validated in a prospective patient cohort. By identifying this range, a step has been taken toward a more rational use of biological therapy in psoriasis. Developing a therapeutic algorithm may lead to less overtreatment of patients and cost savings.

Efficacy of topical Calcipotriol versus combination of topical Calcipotriol plus Betamethasone in the treatment of plaque type psoriasis

Introduction: The effectiveness of various topical agents for the treatment of plaque psoriasis is limited and the results are somewhat not satisfactory to some extent. Topical Calcipotriol can be used either monotherapy or combination therapy with betamethasone. This topical agent has “corticosteroid-sparing” benefit and reduction of side effects, duration of treatment and also relapse rates when used as combination therapy for the treatment of psoriasis. Objectives: The present study was conducted to compare the clinical efficacy between the topical Calcipotriol and combined formulation of topical Calcipotriol plus Betamethasone in the treatment of plaque type psoriasis. Materials and Methods: A clinical trial was carried out from January 2011 to Jan 2014 in outpatient department of Dermatology and Venereology, combined military hospital- Dhaka and Jessore Cantonment and Bangabandhu sheikh Mujib Medical University, Dhaka. Patients of plaque type psoriasis were the study population. Consequitive type of non-probability sampling method was followed in this study. Patients were divided into two groups.Group A was treated with topical Calcipotriol (0.005%) ointment and group B with combination of topical Calcipotriol plus Betamethasone ointment. Results: The mean percentage of Psoriasis Area and Severity Index (PASI) reduction after 4th week of treatment was 39.4 and 35.4 in group A and group B (p value &gt;0.05) and after 8th week of 74 JAFMC Bangladesh. Vol 10, No 1 (June) 2014 therapy was 59.6 in-group A and 60.7 in-group B respectively. The mean baseline PASI score was 6.7±4.5 and after 8th week it was 2.0 ±1.4 for group A and mean baseline PASI score was 5.5 ±4.2 and after 8th week it was 2.5±1.4 for group B. There was statistically significant reduction in PASI score from base line after 8th week of treatment in both treatment groups (p &lt; 0.001). After 8th week of treatment moderate response was 22(73.3%) in group A and 18(60%) in group B. Very good response was 4 (13.3%) in group A and 8 (26.7%) in group B and minimal response of treatment occurs equally 4 (13.3%) in group A and group B. Conclusion: In the light of the findings of this study, topical Calcipotriol(0.005%) alone or combination with Betamethasone is individually effective for the treatment of plaque psoriasis but combination therapy is more effective than monotherapy. Therefore it may be recommended that monotherapy can be replaced by combination therapy in treating plaque psoriasis. DOI: http://dx.doi.org/10.3329/jafmc.v10i1.22929 Journal of Armed Forces Medical College Bangladesh Vol.10(1) 2014

A single-blind study comparing acitretin and narrow-band UVB with the combination of placebo and narrow-band UVB in the treatment of plaque-type psoriasis

A single-blind study comparing acitretin and narrow-band UVB with the combination of placebo and narrow-band UVB in the treatment of plaque-type psoriasis

Effects of Rusanda Spa balneotherapy combined with calcipotriol on plaque psoriasis.

Treatment of psoriasis is very complex and there are no still universal, nor unique treatment modalities. Apart from conventional treatment, which includes topical calcipotriol (vitamin D3 analogue), balneotherapy is drawing increased attention worldwide. Being part of climatotherapy, balneotherapy is defined as the use of natural environmental factors in the treatment of health conditions, whereas in the treatment of psoriasis it means the use of mineral baths and peloids. The aim of this study was to examine the therapeutic efficacy of mineral waters and peloids of the Rusanda Spa on plaque psoriasis in patients also treated with calcipotriol. The study included 60 patients divided into two groups. The first group included patients treated with mineral waters, peloids and calcipotriol in the Rusanda Spa, while the second one included those treated only with calcipotriol. The study took 21 days, and each patient was followed up for at least one month after ending the treatment. The treatment efficacy was measured by psoriasis area severity index (PASI) scores on the days 0, 7, 14 and 21 during the treatment and 30 after the end of the therapy. After a 3-week treatment in the Rusanda Spa, the first group showed a decrease in PASI score by 59.45%, whereas in the group of outpatients treated by calcipotriol it was 39.34%. On the day 30 following the treatment, the first group presented with the PASI score reduction of 58.44%, and the second group of 34.78%. The therapeutic efficacy of mineral waters and peloids combined with calcipotriol showed to be significantly higher in regard to monotherapy with calcipotriol (p < 0.05). In regard to clinical symptoms, the best results were obtained in the reduction of desquamation (p < 0.001). The results of our study show that in the treatment of plaque-type psoriasis, topical calcipotriol combined with Spa Rusanda balineotherapy is more effective than topical calcipotriol alone. Randomized controlled trials are needed to confirm the effects of balneotherapy as monotherapy in treatment of this type of psoriasis.

Low-dose Acitretin in Treatment of Plaque-type Psoriasis: Descriptive Study of Efficacy and Safety

The efficacy and safety of acitretin was evaluated retrospectively in a cohort of 46 patients with moderate to severe plaque psoriasis (Psoriasis Area and Severity Index (PASI) range 10-42). Patients were treated at an initial dose of 10 mg/day acitretin, which was then gradually increased until the best therapeutic effect with the fewest adverse effects was reached (< 50 mg/day) and later decreased and maintained at the lowest effective dosage. Efficacy measures were: (i) PASI75 (75% improvement) and PASI50 between 10 and 16 weeks; and (ii) PASI75 even after 16 weeks of treatment. At weeks 10-16, PASI75 and PASI50 were achieved by 47.8% and 87% of the patients, respectively. Overall, 67.3% reached PASI75. Adverse events occurred in 18 patients (39.1%); among these, 4 (8.7%) discontinued acitretin. Our findings suggest that acitretin at an initial low, gradually escalating dose, and subsequently maintained at the minimal effective dose, is a suitable treatment option for plaque psoriasis as it provides clear-cut improvement in most treated patients while minimizing the risks of side-effects.

Calcipotriol betamethasone ointment combined with narrow band-ultraviolet B in the treatment of plaque-type psoriasis: a randomized controlled study

Objective To assess the efficacy and safety of calcipotriol betamethasone ointment combined with narrow band-ultraviolet B (NB-UVB) for the treatment of plaque-type psoriasis.Methods A randomized,single-blind,parallel-controlled,multi-center clinical trial was conducted.Totally,108 patients with plaque-type psoriasis were randomly divided into the experiment group (treated with NB-UVB plus topical calcipotriol betamethasone ointment once daily in the evening) and control group (treated with NB-UVB only).The treatment lasted four weeks.The safety and efficacy were evaluated at the baseline,as well as two and four weeks after the beginning of treatment.Patients were scheduled for follow-up on week 1,2 and 4 after the end of treatment.Results The response rate was 15.09％ in the experiment group and 2.04％ in the control group after two-week treatment (P ＜ 0.01),77.36％ in the experiment group and 26.53％ in the control group at the end of treatment (P ＜ 0.01).Psoriasis area and severity index (PASI) score was similar between the two groups at the baseline,but significantly different from week 2 to week 8 after the beginning of treatment (all P ＜ 0.0I).Adverse reaction was observed in none of these patients,except for one patient in the control group who developed painful erythema in non-lesional sites of both legs.There was no significant difference in the incidence of adverse reactions between the two groups.Conclusion Calcipotriol betamethasone ointment combined with NB-UVB is a safe and effective treatment choice for plaque-type psoriasis with rapid onset of action.

Efficacy and Safety of Calcipotriene 0.005% Foam for the Treatment of Plaque-Type Psoriasis

Topical calcipotriene is frequently prescribed for the treatment of plaque-type psoriasis. Calcipotriene is currently available in the US as an ointment, a solution, a cream, and in a fixed-dose combination ointment with betamethasone dipropionate. Calcipotriene 0.005% has recently been formulated as a foam using a novel aqueous-based formulation to provide a new topical treatment option for patients with psoriasis. The objective of this study was to evaluate the efficacy and safety of topical calcipotriene 0.005% foam for the treatment of mild to moderate plaque-type psoriasis. Two identical, randomized, double-blind, vehicle-controlled, 8-week phase III clinical trials. Subjects with plaque-type psoriasis affecting 2-20% of the body surface area, with an identifiable target lesion affecting the trunk or extremities, were randomized in a 2:1 ratio to calcipotriene foam (n = 437) or vehicle foam (n = 222). Study medication was applied twice daily for 8 weeks. Treatment success was defined as a score of 0 or 1 (clear or almost clear) on the Investigator's Static Global Assessment (ISGA) psoriasis rating scale and a minimum improvement of ISGA score of at least 2 grades from baseline. Predefined target lesions were assessed for erythema, scaling, and plaque thickness. Primary endpoint was the proportion of subjects in each treatment group who achieved treatment success after 8 weeks, analyzed on an intent-to-treat (ITT) basis. In the primary endpoint analysis, subjects missing 8-week outcomes data were classified as treatment failures regardless of their outcomes at earlier evaluations. As part of the sensitivity analysis, a last-observation-carried-forward (LOCF) approach to impute missing 8-week efficacy outcomes also examined treatment. Secondary endpoints included treatment success as a function of baseline ISGA score (mild or moderate), ISGA score of 0 or 1 (clear or almost clear), and effects of treatment on target lesion. Adverse events (AEs) were recorded throughout the study. In the ITT population of Study 1, treatment success after 8 weeks was achieved by 14% of subjects in the calcipotriene foam group versus 7% of subjects in the vehicle foam group (p = 0.058). In the LOCF analysis, treatment success was achieved by more subjects with calcipotriene foam than with vehicle foam (15% vs 7%; p = 0.034). In Study 2, treatment success was achieved by more subjects in the calcipotriene foam group for the primary endpoint (27% vs 16%; p = 0.016) and the LOCF analysis (28% vs 16%; p = 0.010). Subjects in the calcipotriene foam group exhibited better response rates than did the vehicle foam group for most of the secondary outcomes. Calcipotriene foam was safe with an overall incidence of AEs similar to those experienced in the vehicle foam group. Application-site reactions were noted in approximately 1-2% of subjects in each group. No AE was reported in more than 2% of subjects in the calcipotriene foam group. Treatment was discontinued because of AEs in approximately 2% of subjects in both groups. In two identically designed, phase III clinical trials, calcipotriene 0.005% foam was safe and effective for the treatment of mild to moderate plaque-type psoriasis for up to 8 weeks. Registered at clinicaltrials.gov: NCT00688519 and NCT00689481.

Efficacy and safety of non‐laser, targeted UVB phototherapy alone and in combination with psoralen gel or calcipotriol ointment in the treatment of localized, chronic, plaque‐type psoriasis

Topical drugs enhance the therapeutic effects of ultraviolet (UV)-based therapy for psoriasis. However, their efficacy has yet to be established in a clinical trial. This study aimed to compare the efficacy of targeted microphototherapy alone and in combination with psoralen or calcipotriol in the treatment of plaque-type psoriasis. Thirty individuals, affected by plaque-type psoriasis, were treated with targeted narrowband UVB phototherapy alone (Group 1), in combination with psoralen gel (Group 2), or in combination with calcipotriol ointment (Group 3) three times per week based on predetermined minimal erythema doses for 10 weeks. All patients in each group completed the study. The percentages of improvement in Psoriasis Area and Severity Index (PASI) and Psoriasis Severity Index (PSI) scores were 33.9% and 38.3% in Group 1, 29.9% and 29.8% in Group 2, and 67.2% and 59% in Group 3, respectively. There was no statistically significant difference in improvement between Groups 1 and 2 (P > 0.05). Outcomes in Group 3 were found to be superior compared with those in the other groups. The addition of calcipotriol ointment in targeted phototherapy enhances the therapeutic effects of phototherapy in the treatment of plaque-type psoriasis.

The effect of different pulse durations in the treatment of nail psoriasis with 595-nm pulsed dye laser: A randomized, double-blind, intrapatient left-to-right study

Several studies have proven the efficacy of pulsed dye laser (PDL) in the treatment of plaque type psoriasis. However, only two published studies indicate the effectiveness of PDL on nail psoriasis. We sought to study the effect of different pulse durations in the treatment of nail psoriasis with the 595-nm PDL to determine the optimal pulse duration. Twenty patients with bilateral fingernail psoriasis were recruited and completed a 6-month trial. PDL was applied on the proximal and lateral nailfolds based on random assignment. Forty nails were treated with 6-millisecond pulse duration and 9 J/cm(2) whereas 39 nails were treated with 0.45-millisecond pulse duration and 6 J/cm(2). Patients were blinded to pulse durations. One blinded dermatologist used the Nail Psoriasis Severity Index (NAPSI) to assess the clinical outcome from pretreatment and posttreatment photographs. Patients were monitored for adverse events. Pain was evaluated after the procedure using a visual analog scale assessed by the patient. After 6 months of first treatment, there was a significant reduction in overall NAPSI, nail matrix NAPSI, and nail bed NAPSI scores from baseline in both groups; however, no significant difference was found between the two pulse duration groups. Side effects were mild including transient petechiae and hyperpigmentation. There was no placebo group. PDL was found to be an effective and well-tolerated option in the treatment of nail psoriasis. No significant difference in terms of efficacy was found between the longer and shorter pulse duration treatment groups.

Efficacy of biologics in the treatment of moderate to severe psoriasis: a network meta-analysis of randomized controlled trials

Ustekinumab, a novel monoclonal antibody for the treatment of moderate to severe plaque-type psoriasis, has recently received regulatory approval in Europe, bringing the total number of biologic agents licensed in this indication to five. To assist treatment selection in daily practice it is essential to understand the benefit/risk profile of these agents and in the absence of a clinical trial comparing all available biologics a number of reviews have used statistical techniques to generate estimates of the comparative effectiveness of these therapies through the available network of randomized clinical trials. These estimates have previously been published for a limited range of psoriasis biologic treatments, although, to date no review has compared all the currently available agents in Europe. To estimate the comparative effectiveness of all biologic agents indicated in the treatment of moderate to severe psoriasis currently available in Europe based on the primary trial endpoints. A number of databases were searched for details of randomized controlled trials of available biologics in the treatment of plaque-type psoriasis in adults. Comparative effectiveness was estimated based on the reported Psoriasis Area and Severity Index (PASI) 50, 75 and 90 response rates. A network meta-analysis conducted on the ordered probit scale and implemented as a Bayesian hierarchical model provided estimates for the probability of response and relative risk vs. placebo, based on all observed comparisons. Twenty trials were included in the meta-analysis including patients with a mean disease duration of 18-22years. Based on the indirect comparison and given a placebo PASI 50 response of 13%, infliximab had the highest predicted mean probability of response at PASI levels 50 (93%), 75 (80%) and 90 (54%), followed by ustekinumab 90 mg at 90%, 74% and 46%, respectively, and then ustekinumab 45mg, adalimumab, etanercept and efalizumab. The ordered probit model allowed a quantitative comparison of all currently licensed biologics, providing estimates on comparative effectiveness and a suggested ranking of treatments that is of potential use to decision-makers. However, the analysis is based on indirect comparisons of the primary endpoint reported from short-term randomized trials.

Calcipotriene foam is an effective treatment for plaque-type psoriasis

Calcipotriene foam is an effective treatment for plaque-type psoriasis

Randomized, double-blind, placebo-controlled evaluation of the efficacy of oral psoralen plus ultraviolet A for the treatment of plaque-type psoriasis using the Psoriasis Area Severity Index score (improvement of 75% or greater) at 12 weeks

Randomized, double-blind, placebo-controlled evaluation of the efficacy of oral psoralen plus ultraviolet A for the treatment of plaque-type psoriasis using the Psoriasis Area Severity Index score (improvement of 75% or greater) at 12 weeks

Continuous Treatment of Plaque-Type Psoriasis with Etanercept: An Observational Long-Term Experience

To assess the long-term efficacy and safety profile and the patient-reported outcomes (PRO) in patients with moderate-to-severe plaque-type psoriasis receiving continuous etanercept treatment. An open-label study was conducted to evaluate etanercept as long-term treatment for moderate-to-severe plaque psoriasis. Continuous therapy was administered at a dose of 50 mg subcutaneously twice weekly for 12 weeks followed by a continuous treatment with 50 mg subcutaneously once weekly or 25 mg twice weekly throughout a 96-week study. The primary measure of efficacy was the proportion of patients with PASI 75 at week 24, 48 and 96. Patient-reported outcomes (PRO) were also assessed during the study, at week 24, 48 and 96, including the Dermatology Life Quality Index (DLQI) and the Psoriasis Disability Index (PDI). At baseline, mean PASI score, DLQI and PDI for patients eligible to initiate treatment with etanercept showed significant disease severity, quality-of-life impairment and psoriasis-related disability. At week 96, patients showed statistically significant and meaningful improvements. The continuous etanercept regimen provided a consistent improvement in both clinical disease parameters and PRO measures.

Calcipotriene foam for the treatment of plaque-type psoriasis: Results of two phase III studies

Calcipotriene foam for the treatment of plaque-type psoriasis: Results of two phase III studies