Baseline PASI Research Articles

A study to compare the efficacy and safety of narrow band-UVB alone as well as in combination with topical calcipotriol in patients with psoriasis vulgaris

Psoriasis is a complex disease that requires carefully designed therapy in order to achieve sustained remission. The disease can be effectively controlled by various therapeutic options, used alone or in combination. Phototherapy may be combined with topical or systemic agents to achieve higher clearance rates, longer disease free intervals and a lower carcinogenic risk. The combination of NB-UVB with calcipotriol increases the therapeutic efficacy of phototherapy as well as UVB reduces the irritation caused by calcipotriolThe chief purpose of this study was to compare the efficacy and safety of Narrow Band-UVB alone and in combination with topical calcipotriol in patients with psoriasis vulgaris.Patients with chronic plaque type psoriasis of 100 numbers involving less than 20% of body surface area were randomly allocated to any one of the following 2 groups. Group A- Narrow Band UVB phototherapy. & Group B- Narrow Band UVB with topical calcipotriol ointmentIn group A (NB-UVB), the mean baseline PASI score was 12.1 and the mean PASI score at the end of 12 weeks was 2.54. There was 79% reduction in PASI score at the end of 12 weeks. 31 patients showed good response and 13 patients showed more than 70% clearance.When NB-UVB group was compared with NB-UVB and calcipotriol combination group, there was a significant difference (p<0.05) in PASI scores at 4 weeks, 8 weeks and 12 weeks.Further studies with additional numbers of patients are essential to compare the efficacy and safety of Narrow Band-UVB alone as well as in combination with topical calcipotriol in patients with psoriasis vulgaris

TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial

We report results from a phase IIa study of efficacy and safety of PF-06700841, an oral TYK2/Jak1 inhibitor, in patients with moderate-to-severe plaque psoriasis (NCT02969018). Patients were randomized to PF-06700841 30 mg once daily (QD), 60 mg QD, or placebo (4-week induction), followed by 10 mg QD, 30 mg QD, 100 mg once weekly, or placebo (8-week maintenance). The primary endpoint was week 12 change from baseline in PASI score. Secondary endpoints were the proportion of patients achieving 75% and 90% reduction from baseline PASI at week 12. In total, 212 patients in 35 sites were treated; mean (SD) baseline PASI score was 20.8 (7.68). Decreases in PASI at week 12 were statistically significant compared with placebo in five treatment groups. The greatest change from baseline (least squares mean change -17.3 [95% confidence interval, -20.0 to -14.6]) was observed in the 30-mg QD continuous treatment group. Overall, 136 patients experienced treatment-emergent adverse events, including six serious adverse events in five patients and 13 discontinuations in treatment groups because of adverse events. No herpes zoster cases or major adverse cardiac events including thromboembolic events occurred. PF-06700841 was generally effective and well tolerated in patients with moderate-to-severe plaque psoriasis.

Prevalence of non-alcoholic fatty liver and liver fibrosis in patients with moderate-severe psoriasis: A cross-sectional cohort study.

Several studies have reported that non-alcoholic fatty liver disease (NAFLD) is more frequent in patients with psoriasis, but few have reviewed the presence of liver fibrosis in those patients. Cross-sectional cohort, single-centre study, continuously selecting all patients with moderate-severe psoriasis seen at the Psoriasis Unit of a Tertiary Hospital. The grade of liver steatosis was assessed using liver ultrasound, and the quantity of liver fibrosis was graded using a transitional vibration-controlled elastography (Fibroscan®). A total of 71 patients (66.2% male)were included, with an average age of 46.6years old. The maximum historical PASI average was 14.4 while the baseline PASI average at the time of the study was 2. A third (36%) of patients met the criteria for metabolic syndrome 52% of patients had steatosis; being male, having metabolic syndrome comorbidities, elevated AST/ALT enzymes, dyslipidemia and high initial PASI were significantly related. 14% of patients had moderate liver fibrosis (≥7.6 KPa). In 30% of them, no ultrasound liver steatosis was observed. Elastography may be a useful tool along with ultrasound to evaluate liver disease in patients with psoriasis.

Response to IL-17A inhibitors secukinumab and ixekizumab cannot be explained by genetic variation in the protein-coding and untranslated regions of the IL-17A gene: results from a multicentre study of four European psoriasis cohorts.

BackgroundGenetic predictors for treatment response could optimize allocation of biological treatment in patients with psoriasis. There is minimal knowledge about pharmacogenetics of anti‐IL‐17 agents.ObjectivesTo assess whether genetic variants in the protein‐coding region or untranslated regions of the IL‐17A gene are associated with response to IL‐17A inhibitors in patients with psoriasis.MethodsThis was a multicenter European cohort study investigating pharmacogenetics of IL‐17A inhibitors in patients with psoriasis. Patients with plaque psoriasis treated with secukinumab or ixekizumab in daily practice were included. For all participants, the protein‐coding region and untranslated regions of the IL‐17A gene were analysed using Sanger sequencing. Identified genetic variants were tested for association with response to secukinumab/ixekizumab, measured as ∆PASI, after 12 weeks (primary outcome) and after 24 weeks (secondary outcome). Association was tested using a linear regression model with correction for baseline PASI as a fixed covariate and for biological naivety and body mass index as additional covariates.ResultsIn total, 134 patients treated with secukinumab or ixekizumab were included. Genotyping of the cohort identified genetic variants present in untranslated regions and intronic DNA, but not in the protein‐coding region of the IL‐17A gene. Five genetic variants in non‐coding DNA with a known or suspected functional effect on IL‐17A expression were selected for association analyses: rs2275913, rs8193037, rs3819025, rs7747909 and rs3748067. After 12 weeks, 62% of patients achieved PASI75 and 39% achieved PASI90. At week 24, PASI75 and PASI90 response rates were 72% and 62%, respectively. No associations were found between the five genetic variants and ∆PASI, PASI75 or PASI90 after 12 and 24 weeks of anti‐IL‐17A treatment.ConclusionsResponse to IL‐17A inhibitors secukinumab and ixekizumab cannot be explained by genetic variation in the protein‐coding and untranslated regions of the IL‐17A gene. Pharmacogenetics of IL‐17A inhibitors in the treatment of psoriasis requires further exploration.

Female patients are less satisfied with biological treatment for psoriasis and experience more side-effects than male patients: results from the prospective BioCAPTURE registry.

Female sex has been reported as a predictor for treatment discontinuation with biological therapies for psoriasis, although reasons remain unclear. It can be hypothesized that lower satisfaction with biological treatment in women might add to the lower drug survival rates. To identify possible differences in satisfaction with biological treatment between female and male patients using the Treatment Satisfaction Questionnaire for Medication (TSQM). Data of psoriasis patients treated with biologics were obtained from the prospective, multicentre, daily-practice BioCAPTURE registry. Longitudinal TSQM data were analysed by linear mixed models. Relevant patient characteristics were incorporated as possible confounding factors. Post hoc analysis of adverse events was performed in order to investigate differences between sexes. We included 315 patients with 396 corresponding treatment episodes (137 adalimumab, 90 etanercept, 137 ustekinumab, 24 secukinumab and 8 infliximab). Almost forty per cent of the patients were female. Women had significantly lower baseline PASI scores (P=0.01). Longitudinal analyses demonstrated lower TSQM scores for 'side-effects' (P=0.05) and 'global satisfaction' (P=0.01) in female patients compared with male patients over 1year of treatment. Women reported more relevant adverse events in the context of biologic treatment compared to men (rate ratio 1.79; P<0.001), with more fungal (rate ratio 2.20; P=0.001) and herpes simplex infections (rate ratio 3.25; P=0.005). This study provides a prospective, longitudinal analysis of treatment satisfaction with biologics in female and male patients with psoriasis. Women were slightly less satisfied with treatment regarding side-effects and global satisfaction. Differences in treatment satisfaction and side-effects might add to the fact that women discontinue biological treatments more often.

Remission Duration and Long-Term Outcomes in Patients with Moderate-to-Severe Psoriasis Treated by Biologics or Tofacitinib in Controlled Clinical Trials: A 15-Year Single-Center Experience.

IntroductionRelapse is common after treatment discontinuation for patients with moderate-to-severe psoriasis. The objective of this study was to understand the remission duration and long-term outcomes in psoriasis patients after biologic withdrawal.MethodsWe retrospectively included the follow-up data of 184 patients with moderate-to-severe psoriasis after the end of 11 biologic or tofacitinib trials conducted between 2004 and 2016.ResultsAmong the 232 treatment courses, 95 achieved (psoriasis area and severity index) PASI 75 at the end of the studies. At 6 months after treatment discontinuation, the systemic treatment-free rates of our patients who entered the PRESTA, PRISTINE, PEARL, ERASURE, CLEAR, the global tofacitinib study, and the IXORA-P study were 66.7%, 66.7%, 75.0%, 16.7%, 22.2%, 33.3%, and 29.2%, respectively. Pooled data showed a serious adverse event incidence rate of 1.5/100 person-years. The proportions of systemic treatment-free episodes were 16.8%, 7.4%, 4.3%, 3.2%, and 3.2% at 1, 2, 3, 4, and 5 years, respectively. Biologics were reinitiated in 41.9%, 66.7%, 77.1%, 83.5%, and 86.1% at 1, 2, 3, 4, and 5 years, respectively. Multivariate generalized estimating equation (GEE) regression analysis demonstrated that predictors for a longer relapse-free duration were baseline PASI, PASI improvement, biologic naivety, and early biologic intervention. Patients who received early biologic intervention, who achieved PASI 90, and who were biologic naive showed significantly higher relapse-free rate by Kaplan–Meier analysis with log rank test.ConclusionsSystemic treatment was required in 86.1% of patients within 12 months after biologic withdrawal and biologics were reinitiated in 77.1% of patients after 3 years. However, early biologic administration within 2 years after diagnosis demonstrated a lower risk of relapse in patients with moderate-to-severe psoriasis.

Comparative study of oral methotrexate and narrow band ultraviolet-B in chronic plaque psoriasis: a study from urban Karnataka

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Treatment of psoriasis continues to be a challenge. It is often frustrating experience for dermatologists. Methotrexate or PUVA or NBUVB when used properly, can produce good to excellent clinical benefit with minimal side effects. The objective of the study was to compare the efficacy and safety of oral methotrexate and NBUVB in the treatment of chronic plaque psoriasis.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; 100 patients of chronic plaque psoriasis attending the skin department of Navodaya Medical College and Hospital, Raichur from November 2012 to April 2014 were included in the study. Group A exhibited to Oral methotrexate and group B to NBUVB. Outcome was measured in terms of PASI 75 (it means 75% reduction in original PASI). Data was analysed using SPSS 19.0 version.&lt;strong&gt;&lt;/strong&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; In Group A mean age was 33.68 years and in Group B mean age 33.7 years. The difference in mean PASI at baseline, at 4 and 8 weeks using oral methotrexate as well as NBUVB was found to be highly significant (&amp;lt;0.001). PASI score was less in-group using methotrexate at 4 and 8 weeks interval (&amp;lt;0.05). Mean time taken for PASI 75 in the baseline PASI score in Group A was 9.62±1.3 weeks whereas in Group B it was 11.3±0.7 weeks. Side effects were higher in group B (60%) compared to group A (36%).&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; Improvement in the PASI score was best with methotrexate than NBUVB. The side effects observed in a methotrexate were minimal compared to NBUVB.&lt;/p&gt;

Use of Ustekinumab in the Treatment of Libyan Psoriasis Vulgaris Patients

Abstract Introduction. Psoriasis is a relatively common chronic inflammatory disease. It clinically manifests as raised, well defined erythematous plaques with irregular borders and silvery scales. Psoriasis appears to be mediated by abnormal immune system functioning, including T lymphocyte and macrophage activation and release of various cytokins, such as interleukin 12 (IL-12) and IL-23. Recently a new biologic agent Ustekinumab has been used in the treatment of psoriasis. Our aim in this study was to assess the efficacy and tolerability of ustekinumab in moderate to severe psoriasis vulgaris and to observe and report any adverse reaction. Material and Methods. Thirty five psoriatic patients above the age of 18 years having moderate to severe psoriasis were included in this study. Ustekinumab is available in pre-filled syringe 45mg/0.5ml, 90mg/1.0ml for subcutaneous injection according to body weight at the intervals of 0, 4 weeks, and then every 12 weeks. It is given in hospital by a doctor or specialist nurse. The assessment of the patients’ condition and improvement was carried out after administering each dose using PASI score. Results. Thirty five patients were included in this study. Baseline PASI score of our patients ranged from 11.4 to 39.8 (mean: 21.1).There was a dramatic response to treatment with ustekinumab in which PASI decreased to 6.7 after the second dose, followed by subsequent responses that reached 2.6 after the 6th dose. After the second dose, 61% of the cases had marked improvement and 11% had clearance of their skin lesions. After the last, sixth dose there was a marked improvement in 65% of cases and the percentage of complete clearance increased to 24%. Ustekinumab had positive effect on psoriatic nail changes as well-there was a significant improvement in 50% of cases and complete clearance (cure) in 24% of cases. Conclusion: Ustekinumab is effective in the treatment of severe and resistant cases of psoriasis vulgaris. It is well tolerated by the patients. No reactions or serious side effects have been reported.

Tildrakizumab for the treatment of psoriasis

ABSTRACTIntroduction: Psoriasis is an immune-mediated skin disease amenable to targeted immunotherapy. Tildrakizumab is a humanized IgG1 monoclonal antibody targeting interleukin-23 p19 and is approved for use in moderate to severe psoriasis.Areas covered: This article reviews the mechanism of action, pharmacokinetics, safety, tolerability, and clinical efficacy of tildrakizumab, administered subcutaneously every 12 weeks, in treatment of moderate to severe psoriasis.Expert commentary: In two phase 3 clinical trials, tildrakizumab showed a consistent low occurrence of adverse events, underlining safety and tolerance. The long half-life permits subcutaneous injections every 12 weeks. Seventy eight percent of patients achieved PASI 75 (a > 75% improvement from baseline PASI) at 28 weeks, 58% achieved PASI 90, 29% achieved PASI 100 and 70% achieved a Physician’s Global Assessment score of clear or almost clear. A high proportion of patients maintained PASI response after 2 years of treatment. Tildrakizumab improved Dermatology Life Quality Index, psoriasis-related personal relationship problems and sexual difficulties. Baseline PASI score, PGA, and BMI were not predictive of PASI 90 response at week 12, however achievement of PASI 50 by week 8 was predictive of a PASI 90 response at week 12.

PSS16 - COST PER RESPONDER ANALYSIS OF CALCIPOTRIOL PLUS BETAMETHASONE DIPROPIONATE AEROSOL FOAM VERSUS NON-BIOLOGIC SYSTEMIC THERAPY IN THE TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS

To compare the cost and efficacy of calcipotriol plus betamethasone dipropionate (Cal/BD) aerosol foam, used according to label, versus non-biologic systemic therapies in moderate to severe psoriasis. A series of matching-adjusted indirect comparisons (MAIC), matched on baseline characteristics, were used to compare 4-week efficacy (defined as ≥75% improvement on Psoriasis Area and Severity Index [PASI]) of Cal/BD foam versus 12-week efficacy of methotrexate (MTX), acitretin (AC), fumaric acid ester (FAE) and 16-week efficacy of apremilast (APR) for psoriasis patients (mean baseline PASI 7.3±4.6; BSA 7.3±6.1). Relevant comparators were defined by availability in the UK (APR, MTX, AC and FAE), Spain (APR, MTX and AC) and Portugal (MTX and AC). Cal/BD foam mean usage at week 4 was obtained from a pooled analysis of four studies and SmPC doses were considered for comparators. Drug and monitoring costs were calculated for each country based on local requirements and databases. Results were presented as cost per PASI75 responder. In the UK, Cal/BD foam was associated with a cost of less than £270 per responder compared to MTX (£1,287), APR (£9,179), AC (£1,617) and FAE (£2,097). In Spain, the cost per responder of Cal/BD foam was lower (€350) when compared to MTX oral and MTX IV (€882 and €1,310 per responder, respectively), APR (€15,728) and AC (€987). In Portugal, Cal/BD foam was associated with a cost per responder of less than €250 when compared to MTX oral and MTX IV (€553 and €1,366 per responder, respectively) and to AC (€918). Results were robust across scenarios exploring different assumptions for treatment duration and efficacy. The cost per PASI75 responder was lowest with Cal/BD foam, driven by higher efficacy and lower costs compared to oral systemics. Cal/BD foam is therefore likely to be a cost-effective treatment choice in UK, Spain and Portugal.

Identifying demographic, social and clinical predictors of biologic therapy effectiveness in psoriasis: a multicentre longitudinal cohort study.

SummaryBackgroundBiologic therapies have revolutionized the treatment of moderate‐to‐severe psoriasis. However, for reasons largely unknown, many patients do not respond or lose response to these drugs.ObjectivesTo evaluate demographic, social and clinical factors that could be used to predict effectiveness and stratify response to biologic therapies in psoriasis.MethodsUsing a multicentre, observational, prospective pharmacovigilance study (BADBIR), we identified biologic‐naive patients starting biologics with outcome data at 6 (n = 3079) and 12 (n = 3110) months. Associations between 31 putative predictors and outcomes were investigated in univariate and multivariable regression analyses. Potential stratifiers of treatment response were investigated with statistical interactions.ResultsEight factors associated with reduced odds of achieving ≥ 90% improvement in Psoriasis Area and Severity Index (PASI 90) at 6 months were identified (described as odds ratio and 95% confidence interval): demographic (female sex, 0·78, 0·66–0·93); social (unemployment, 0·67, 0·45–0·99); unemployment due to ill health (0·62, 0·48–0·82); ex‐ and current smoking (0·81, 0·66–0·99 and 0·79, 0·63–0·99, respectively); clinical factors (high weight, 0·99, 0·99–0·99); psoriasis of the palms and/or soles (0·75, 0·61–0·91); and presence of small plaques only compared with small and large plaques (0·78, 0·62–0·96). White ethnicity (1·48, 1·12–1·97) and higher baseline PASI (1·04, 1·03–1·04) were associated with increased odds of achieving PASI 90. The findings were largely consistent at 12 months. There was little evidence for predictors of differential treatment response.ConclusionsPsoriasis phenotype and potentially modifiable factors are associated with poor outcomes with biologics, underscoring the need for lifestyle management. Effect sizes suggest that these factors alone cannot inform treatment selection.

Pharmacokinetic Characteristics of Tofacitinib in Adult Patients With Moderate to Severe Chronic Plaque Psoriasis.

Tofacitinib is an oral Janus kinase (JAK) inhibitor. This study characterized the pharmacokinetics of tofacitinib in patients with psoriasis and evaluated the impact of patient factors on disposition. Pooled phase 2/3 data (2981 patients: 9735 concentrations, dose range: 2-15mg twice daily) up to 56 weeks were used for modeling. A one-compartment model parameterized in terms of apparent oral clearance (CL/F), apparent volume of distribution, zero-order absorption (duration, D), with interindividual variability and inter-occasion variability terms, described tofacitinib pharmacokinetics. A full covariate model incorporated effects for age, sex, race, ethnicity, and baseline variables (body weight, Psoriasis Area Severity Index [PASI], C-reactive protein [CRP], creatinine clearance [CrCl]). The parameter estimates (95%CI) for CL/F, Vd/F, and D in a typical individual (white, male, 86kg, 46 years, CrCl 121 mL/min, PASI 19.8, and CRP 0.267mg/dL) were 26.7 (25.9, 27.5) L/h, 125 (120.8, 128.3) liters, and 0.69 (0.646, 0.735) hours, respectively. Only CrCl led to clinically relevant changes in exposure. The analysis suggested no dosing modifications for age, body weight, sex, race, ethnicity, baseline PASI, or CRP based on the magnitude of exposure change. Dosing adjustments for renal impairment were derived from a separate phase 1 study.

Comparative Effectiveness of Adalimumab versus Secukinumab for the Treatment of Psoriatic Arthritis: A Matching-Adjusted Indirect Comparison.

IntroductionThe Phase III FUTURE I and II trials demonstrated the clinical efficacy of secukinumab in active psoriatic arthritis (PsA). In the absence of head-to-head trials, this study compared the clinical efficacy and cost effectiveness of adalimumab 40 mg versus secukinumab 150 and 300 mg for the treatment of active PsA.MethodsA matching-adjusted indirect comparison was conducted using individual patient data from the ADEPT trial of adalimumab and published data from FUTURE I and II. To adjust for the cross-trial differences, individual patients in ADEPT were re-weighted so that the mean baseline characteristics (including age, weight, gender, race, baseline methotrexate use, psoriasis ≥3% body surface area, baseline PASI score, presence of dactylitis and enthesitis, and HAQ-DI) matched those in the FUTURE trials. Response rates relative to placebo and incremental costs per responder (CPR) over 24 weeks for ACR 20/50/70 and PASI 75/90 were compared between adalimumab and secukinumab 150 and 300 mg from the German social health insurance (SHI) perspective.ResultsAfter matching, mean baseline characteristics were balanced across the ADEPT and the FUTURE I and II populations. The mean differences between adalimumab and secukinumab 150 mg in relative ACR 20/50/70 and PASI 75/90 response rates were 9.5, 3.0, 6.0, 13.1, and 6.7%, respectively (p > 0.05 for all comparisons). Post-match relative ACR 20/50/70 and PASI 75 to placebo were also higher with adalimumab compared to secukinumab 300 mg. Adalimumab had lower incremental costs per responder over 24 weeks for all outcomes compared with secukinumab 150 and 300 mg.ConclusionsIn the absence of direct comparisons between adalimumab and secukinumab, this study provides valuable and reliable evidence for physicians and payers. After adjusting for cross-trial differences in baseline characteristics, adalimumab was associated with higher relative ACR and PASI rates and lower incremental CPRs compared with secukinumab 150 mg or 300 mg at week 24 among patients with active PsA.FundingAbbVie.

Factors associated with the choice of the first biologic in psoriasis: real-life analysis from the Psobioteq cohort.

Decision-making is a complex process. The aim of our study was to assess factors associated with the choice of the first biological treatment in patients with moderate-to-severe psoriasis. Data on all patients included in the French prospective, observational, cohort, Psobioteq and initiating a first biologic prescription between July 2012 and July 2016 were analysed. Demographic information and clinical features were collected during routine clinical assessments by the dermatology team at the recruiting centres using a standardized case report form. The primary outcome was the nature of the first biologic treatment. Four groups were identified as follows: adalimumab, etanercept, ustekinumab and infliximab groups. Factors associated with the choice of the first biological agent were determined by a multinomial logistic regression model adjusted on year of inclusion. The study population included the 830 biological-naïve patients who initiated a first biological agent. The mean age was 46.6years (±SD 13.9), and 318 patients (38.3%) were female. The most commonly prescribed biologic was adalimumab: 355 (42.8%) patients, then etanercept (n=247, 29.8%), ustekinumab (n=194, 23.4%) and infliximab (n=34, 4.0%). In the multinomial logistic regression analysis, patients were significantly more likely to receive adalimumab if they had a severe psoriasis as defined by baseline PASI or if they had psoriatic arthritis compared to etanercept (aOR, 0.42; 95% CI, 0.16-1.07) and ustekinumab (aOR, 0.15; 95% CI, 0.04-0.52). Patients were significantly more likely to receive ustekinumab (aOR, 2.39; 95% CI, 1.04-5.50) if they had a positive screening for latent tuberculosis compared to adalimumab. Younger patients were also more likely to receive ustekinumab. Patients with chronic obstructive pulmonary disease were more likely to be prescribed ustekinumab or etanercept compared to adalimumab. There was a trend in favour of etanercept prescription in patients with cardiovascular comorbidities, metabolic syndrome and in patients with a history of cancer. We identified patient- and disease-related factors that have important influence on the choice of the first biological agent in clinical practice. Clinicians appear to have a holistic approach to patient characteristics when choosing a biological agent in psoriasis.

Frequency and predictors of a high clinical response in patients with psoriasis on biological therapy in daily practice: results from the prospective, multicenter BioCAPTURE cohort.

It is important to assess which patients with psoriasis are more likely to achieve high clinical responses on biologics. To assess the number of treatment episodes (TEs) that achieve a 100% improvement in Psoriasis Area and Severity Index (PASI 100), PASI 90 or PASI ≤ 5 at week 24 of biological treatment, and which baseline patient characteristics predict treatment response. Data from patients with psoriasis treated with adalimumab, etanercept, infliximab or ustekinumab were extracted from a prospective cohort. TEs with high clinical responses were described. Uni- and multivariate regression analyses were performed with the generalized estimating equation method to elucidate which baseline patient characteristics were predictors for PASI 90 and PASI ≤ 5 at week 24. In total, 454 TEs were extracted (159 adalimumab; 193 etanercept; 19 infliximab; 83 ustekinumab) from 326 patients. At week 24, in 3%, 15% and 59% of TEs, respectively, PASI 100, PASI 90 and PASI ≤ 5 was reached. In TEs without a PASI 100 or PASI 90 response, PASI ≤ 5 was still achieved in 58% and 52%, respectively. Baseline PASI ≥ 10 was a strong predictor for achieving PASI 90; baseline PASI < 10 and a lower baseline body mass index (BMI) were significant predictors for PASI ≤ 5 at week 24. A limited number of patients achieved PASI 100 or PASI 90 at 24 weeks of biological treatment. Including an absolute PASI score in the assessment of psoriasis severity is important. Baseline BMI was an important, modifiable predictor for a high response.

The role of biologics in the treatment of moderate-to-severe plaque psoriasis

Psoriasis is a chronic, relapsing, inflammatory skin disease requiring long-term treatment and in many cases involving a reduction in the quality of life. Treatment with biologics is indicated in patients with moderate-to-severe psoriasis who do not respond or cannot be treated with conventional systemic drugs, and the therapeutic goal is an improvement of 90% (or at least 75%) with respect to baseline PASi at the end of the induction phase, which should be maintained long-term in the mainternance phase of treatment. Before starting treatment with a biological agent it is necessary to review the contraindications and precautions, rule out latent tuberculosis infection and complete the pending immunizations. Biological agents have a more favorable safety profile than classical systemic treatments; the most common side effects are mild and rarely involve the discontinuation of treatment. The treatment decision will be based on individual characteristics and patient preferences, functional limitation, expected speed of onset of effect, adverse reactions, availability and cost of treatment.

English

Psoriasis is a chronic inflammatory disease with frequent relapses and remissions. The introduction of biologicas increased the remission periods, decreases relapse and hence improve the quality of life. Method: The study includes 17 adult patients of chronic plaque psoriasis, who received etanercept subcutaneously at a dosage of 50 mg once weekly for 24 weeks, followed by 6 months follow up. Results: At the end of 12 weeks 8 patients (47.05%) achieved more than 75% reduction of PASI and at the end of 24 weeks 9 patients(52.94%) achieved more than 75% reduction of PASI. Conclusion: Our study shows that etanercept has good efficacy without any significant side effects and it should be considered in patients with moderate to severe chronic plaque psoriasis not responding to other conventional modes of therapy. INTRODUCTION Psoriasis is a chronic inflammatory skin condition affecting approximately 2 % of the general population. Even though it has several clinical variants, chronic plaque type is the commonest that presents with silvery white scales on an erythematous base. Some patients may have associated joint involvement. The pathogenesis of psoriasis is complex it includes both innate and adaptive immune systems. Cytokines Th1 and Th17 cells have been incriminated in the pathogenesis of psoriasis. These cytokines secrete TNFα and IFN – α that leads to vasodilatation ,leukocyte migration and keratinocyte activation. This leads to activation of dendritic cells that creates a repeated cycle of inflammation. Biologics are the agents that targets genetic or immune mediator of pathophysiological process.. Among the biologics Infliximab, Etanercept, and Adalimumab targets TNF-α. Eternacept is a human fusion protein of the TNF receptor to Fc portion of IgG which binds to TNF –α to neutralize its effects. Various international studies have showed eternacept has good efficacy in chronic plaque type of psoriasis. With this background we conducted a study on efficacy of eternacept in chronic plaque psoriasis. *Corresponding author: Email: ramasamypp@yahoo.com http://dx.doi.org/10.20530/IJTA_31_18-21 ISSN 2320-138X © 2016 Table 1: Baseline PASI Score NO: AGE/SEX BASELINE PASI

Weekly methotrexate versus daily isotretinoin to treat moderate-to-severe chronic plaque psoriasis: a comparative study

Introduction: There is paucity of data on efficacy of isotretinoin versus methotrexate in psoriasis patients. Aims: We compared the efficacy and safety of once a week methotrexate and daily isotretinoin for the treatment of moderateto-severe chronic plaque psoriasis. Methods: 43 (M: F 30:13) consenting patients having moderate-to-severe chronic plaque psoriasis were divided on alternate basis in Group-A for treatment with methotrexate (15mg/week) and Group-B for isotretinoin (30mg/d) therapy. The clinical response was assessed by the percentage reduction in the baseline PASI scores during next 12 weeks. Results: 14 patients in Group-A and 11 patients in Group-B completed the study. The mean percentage reduction in the PASI score was 79.78 ± 20.68 in the methotrexate group and 51.92 ± 23.83 in the isotoin group at the end of 12 weeks. Five patients in Group-A achieved >75% reduction in the PASI score, while only 3 patients in Group-B showed similar results at the end of 12 weeks signifying faster disease clearance with methotrexate. Isotretinoin-related serious adverse effects were fewer and did not warrant treatment discontinuation. Conclusions: Isotretinoin may be an option for alternative therapy in patients who cannot afford acetretin, are intolerant to methotrexate, have achieved its cumulative dose, or in rotational therapy.

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

Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1)

Apremilast works intracellularly to regulate inflammatory mediators. ESTEEM 1 evaluated efficacy/safety of apremilast at 30 mg twice a day for moderate to severe plaque psoriasis. This phase III, multicenter, double-blind, placebo-controlled study randomized adults (2:1) to apremilast or placebo. At week 16, the placebo group switched to apremilast through week 32, followed by a randomized treatment withdrawal phase to week 52. Binary end points were analyzed using χ(2) test; continuous end points used analysis of covariance. In all, 844 patients were randomized (n= 282, placebo; n= 562, apremilast). At week 16, significantly more patients taking apremilast achieved 75% or greater reduction from baseline Psoriasis Area and Severity Index score (PASI-75) (33.1%) versus placebo (5.3%, P < .0001; primary end point). Most (61.0%) patients rerandomized to apremilast at week 32 achieved PASI-75 at week 52 versus 11.7% rerandomized to placebo. Of patients rerandomized to apremilast at week 32, mean percentage change from baseline PASI score was -88% to -81% (weeks 32-52). During the placebo-controlled period, 55.7% and 69.3% of patients randomized toplacebo and apremilast, respectively, had 1 or more adverse events. Most adverse events were mild/moderate in severity. No new significant adverse events emerged with continued apremilast exposure versus the placebo-controlled period. Data were limited to 52 weeks and may not generalize to nonplaque psoriasis. Apremilast was effective in moderate to severe plaque psoriasis.