Adalimumab therapy for psoriasis in real-world practice: efficacy, safety and results in biologic-naïve vs. non-naïve patients. Severe psoriasis--oral therapy with a new retinoid. Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. Risk of serious adverse events associated with biologic and nonbiologic psoriasis systemic therapy: patients ineligible vs eligible for randomized controlled trials. Secukinumab in plaque psoriasis--results of two phase 3 trials. Results of three analytical approaches on long-term efficacy of etanercept for psoriasis in daily practice. Fumaric acid esters in the treatment of psoriasis: an Italian experience Efficacy and Safety of Clinical Use of Etanercept for the Treatment of Moderate-to-Severe Psoriasis in Spain: Results of a Multicentric Prospective Study at 12 Months Follow-Up Responses to ustekinumab in the anti-TNF agent-naïve vs. anti-TNF agent-exposed patients with psoriasis vulgaris. Etanercept and efalizumab treatment for high‐need psoriasis. Effects and side effects in a prospective cohort study in outpatient clinical practice Switching from etanercept to adalimumab is effective and safe: results in 30 patients with psoriasis with primary failure, secondary failure or intolerance to etanercept
BACKGROUND Patients and the course of treatment in daily practice are different from r and omized controlled trials ( RCTs ) . OBJECTIVES PRIMARY OBJECTIVE to analyse the percentage of patients achieving PASI 75 .  SECONDARY OBJECTIVES PASI 50 , PASI 90 , PASI 100 responses , the percentage of patients experiencing at least one serious adverse event ( SAE ) and the response in biologic-naïve vs. non-naïve patients . METHODS Prospect ively collected efficacy and safety data of a cohort of psoriasis patients treated with adalimumab in daily practice between May 2007 and July 2011 were analyzed . Efficacy was determined using an intention-to-treat analysis and an as treated analysis , in comparison with the course baseline PASI before the start of adalimumab and the original baseline PASI before the start of any biologic therapy . RESULTS Eighty-five patients received adalimumab therapy with a mean treatment duration of 1.4 ( range 0.02 - 3.1 ) years . Compared with the original baseline PASI , PASI 75 response rates at week 12 and 24 were 34 % and 38 % ( ITT ) . PASI 75 responses were well maintained until week 132 . Only the PASI 75 response rate at week 12 differed significantly between biologic-naïve ( 56 % ) and non-naïve patients ( 29 % ) . Sixteen patients ( 19 % ) experienced 28 SAEs . Seven patients ( 8 % ) experienced SAEs considered possibly or probably related to adalimumab . CONCLUSIONS In this cohort , PASI75 responses were substantial but lower than in RCTs and other daily practice studies . Efficacy was well maintained during more than 2 years of follow-up and differed only between biologic-naïve and non-naïve patients at week 12 . The incidence of SAEs was low but seems higher than observed in RCTs Ro 10 - 9359 is a retinoic acid derivative , selected for study because of a better tolerance than retinoic acid , shown in animal experiments . Doses of 25 mg b.i.d . , 25 mg t.i.d . and 50 mg b.i.d . were administered orally to 27 patients suffering from severe chronic generalized psoriasis . The clinical efficacy was evaluated by means of a new index , psoriasis area and severity index ( PASI ) based on severity and area of psoriatic lesions . At doses of 25 mg t.i.d . or 50 mg b.i.d . Ro 10 - -9359 proved to be an extremely potent antipsoriatic drug . A more than 90 % reduction of psoriatic lesions could be seen in 10 patients out of 20 after 4 - 8 weeks of treatment . This good effect lasted about 5 weeks after treatment . Side effects were frequent , but mostly mild and completely reversible after termination of treatment BACKGROUND Biologic agents offer a range of new therapeutic options for patients with psoriasis ; however , the relative benefit-risk profiles of such therapies are not well known . We compared two biologic agents , ustekinumab ( an interleukin-12 and interleukin-23 blocker ) and etanercept ( an inhibitor of tumor necrosis factor alpha ) , for the treatment of psoriasis . METHODS We r and omly assigned 903 patients with moderate-to-severe psoriasis to receive subcutaneous injections of either 45 or 90 mg of ustekinumab ( at weeks 0 and 4 ) or high-dose etanercept ( 50 mg twice weekly for 12 weeks ) . The primary end point was the proportion of patients with at least 75 % improvement in the psoriasis area- and -severity index ( PASI ) at week 12 ; a secondary end point was the proportion with cleared or minimal disease on the basis of the physician 's global assessment . Assessors were unaware of the treatment assignments . The efficacy and safety of a crossover from etanercept to ustekinumab were evaluated after week 12 . RESULTS There was at least 75 % improvement in the PASI at week 12 in 67.5 % of patients who received 45 mg of ustekinumab and 73.8 % of patients who received 90 mg , as compared with 56.8 % of those who received etanercept ( P=0.01 and P<0.001 , respectively ) . Similarly , 65.1 % of patients who received 45 mg of ustekinumab and 70.6 % of patients who received 90 mg of ustekinumab had cleared or minimal disease according to the physician 's global assessment , as compared with 49.0 % of those who received etanercept ( P<0.001 for both comparisons ) . Among patients who did not have a response to etanercept , 48.9 % had at least 75 % improvement in the PASI within 12 weeks after crossover to ustekinumab . One or more adverse events occurred through week 12 in 66.0 % of patients who received 45 mg of ustekinumab and 69.2 % of patients who received 90 mg of ustekinumab and in 70.0 % who received etanercept ; 1.9 % , 1.2 % , and 1.2 % , respectively , had serious adverse events . Safety patterns were similar before and after crossover from etanercept to ustekinumab . CONCLUSIONS The efficacy of ustekinumab at a dose of 45 or 90 mg was superior to that of high-dose etanercept over a 12-week period in patients with psoriasis . ( Clinical Trials.gov number , NCT00454584 . OBJECTIVE To describe the use of systemic therapy for psoriasis  ( biologic and nonbiologic [ classic ] drugs ) in patients not adequately represented in r and omized controlled trials ( RCTs ) and the risk of serious adverse events ( SAEs ) in these patients . DESIGN A registry inception cohort was used . SETTING Thirteen dermatology departments in Spain participated . PATIENTS A consecutive sample of patients treated with biologics and a systematic sample of patients treated with classic systemic therapy  were evaluated . A total of 1042 patients ( 2179 person-years ) were included . EXPOSURE Inadequate representation in trials was defined as the presence of any of the following factors : elderly age ( > 70 years ) ; type of psoriasis other than chronic plaque psoriasis ; history of infection caused by hepatitis B , hepatitis C , or human immunodeficiency virus ; history of cancer ( excluding nonmelanoma skin cancer ) ; and chronic renal or hepatic disease . MAIN OUTCOME MEASURES Serious adverse events as defined by the International Conference on Harmonization were evaluated . RESULTS In all , 29.8 % of patients receiving systemic therapy for psoriasis would not have been eligible for RCTs . These individuals had an increased risk of SAEs ( incidence rate ratio , 2.7 ; 95 % CI , 1.5 - 4.7 ) . Patients exposed to biologics had an adjusted increased risk of SAEs ( incidence rate ratio , 2.3 ; 95 % CI , 1.1 - 4.8 ) that was similar in patients eligible and ineligible for RCTs . CONCLUSIONS Patients ineligible for RCTs are an important proportion ( 30 % ) of those receiving systemic therapy for psoriasis . These patients have a higher risk of SAEs and should be closely monitored . Patients exposed to biologics ( whether these patients are eligible for RCTs or ineligible ) are susceptible to the same increase in risk of SAEs , but biologics add to a higher baseline risk in patients who are ineligible for RCTs . The risk-benefit ratio in ineligible patients receiving biologics might be different from the ratio in eligible patients BACKGROUND Interleukin-17A is considered to be central to the pathogenesis of psoriasis . We evaluated secukinumab , a fully human anti-interleukin-17A monoclonal antibody , in patients with moderate-to-severe plaque psoriasis . METHODS In two phase 3 , double-blind , 52-week trials , ERASURE ( Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis ) and FIXTURE ( Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis ) , we r and omly assigned 738 patients ( in the ERASURE study ) and 1306 patients ( in the FIXTURE study ) to subcutaneous secukinumab at a dose of 300 mg or 150 mg ( administered once weekly for 5 weeks , then every 4 weeks ) , placebo , or ( in the FIXTURE study only ) etanercept at a dose of 50 mg ( administered twice weekly for 12 weeks , then once weekly ) . The objective of each study was to show the superiority of secukinumab over placebo at week 12 with respect to the proportion of patients who had a reduction of 75 % or more from baseline in the psoriasis area- and -severity index score ( PASI 75 ) and a score of 0 ( clear ) or 1 ( almost clear ) on a 5-point modified investigator 's global assessment ( co primary end points ) . RESULTS The proportion of patients who met the criterion for PASI 75 at week 12 was higher with each secukinumab dose than with placebo or etanercept : in the ERASURE study , the rates were 81.6 % with 300 mg of secukinumab , 71.6 % with 150 mg of secukinumab , and 4.5 % with placebo ; in the FIXTURE study , the rates were 77.1 % with 300 mg of secukinumab , 67.0 % with 150 mg of secukinumab , 44.0 % with etanercept , and 4.9 % with placebo ( P<0.001 for each secukinumab dose vs. comparators ) . The proportion of patients with a response of 0 or 1 on the modified investigator 's global assessment at week 12 was higher with each secukinumab dose than with placebo or etanercept : in the ERASURE study , the rates were 65.3 % with 300 mg of secukinumab , 51.2 % with 150 mg of secukinumab , and 2.4 % with placebo ; in the FIXTURE study , the rates were 62.5 % with 300 mg of secukinumab , 51.1 % with 150 mg of secukinumab , 27.2 % with etanercept , and 2.8 % with placebo ( P<0.001 for each secukinumab dose vs. comparators ) . The rates of infection were higher with secukinumab than with placebo in both studies and were similar to those with etanercept . CONCLUSIONS Secukinumab was effective for psoriasis in two r and omized trials , validating interleukin-17A as a therapeutic target . ( Funded by Novartis Pharmaceuticals ; ERASURE and FIXTURE Clinical Trials.gov numbers , NCT01365455 and NCT01358578 , respectively . ) BACKGROUND A problem encountered when analyzing long-term efficacy is that the number of patients in follow-up decreases with time for different reasons . The method used to account for missing observations for the therapy under analysis has a great influence on the inference of efficacy . OBJECTIVE To describe the long-term efficacy of etanercept for psoriasis in daily practice using 3 analytical approaches . METHODS Prospect i ve data from a cohort of patients with psoriasis treated with etanercept for at least 24 weeks were analyzed using 3 analytical approaches : as treated analysis , intention-to-treat analysis ( ITT ) with last observation carried forward ( LOCF ) and intention-to-treat analysis with modified nonresponder imputation ( modified NRI ) . RESULTS One hundred thirty-one patients were treated with etanercept during 134 treatment episodes with a mean treatment duration of 2.7 years . The maximum follow-up was 6.0 years . The method ological approach chosen had a great influence . Psoriasis Area and Severity Index ( PASI ) 75 response rates varied from 60 % in the as-treated approach to 34 % in LOCF and to 29 % in modified NRI at week 264 . LIMITATIONS All analytical methods applied have limitations . Other outcome measures could be used to overcome the bias introduced by each method of analysis , such as drug survival . CONCLUSIONS The method ological approach chosen to analyze long-term efficacy data has a great influence on the inferences that may be drawn regarding the degree of efficacy . Therefore we support the use of different methods to present long-term efficacy data BACKGROUND : Psoriasis is a common , chronic , cell‐mediated , inflammatory skin disease . Treatment limitations and a developing underst and ing of its pathogenesis on a molecular level have encouraged much interest in the field of immunomodulatory therapy . OBJECTIVE : To evaluate the efficacy and safety of fumaric acid esters , in particular dimethylfumarate ( DMF ) , in the treatment of moderate to severe plaque psoriasis intolerant and /or resistant to other conventional systemic therapies . METHODS : A total of 40 patients were enrolled in this study .  DMF was orally administered at the daily dose of 30 mg up to 360 mg for a minimum of 6 months treatment . Patients were followed‐up with psoriasis area and severity index ( PASI ) score assessment , and clinical and photographic documentation . RESULTS : A total of 33 ( 82.5 % ) patients achieved complete clinical remission  with DMF treatment : eight after 3 months and 25 after 6 months . Adverse events , such as intolerable abdominal cramps and incoercible diarrhoea , occurred in four patients who , for this reason , interrupted therapy . CONCLUSION : The findings suggest that DMF is a safe , effective and well‐tolerated long‐term oral treatment worthy of consideration for selective patients Background : The efficacy of etanercept in the treatment of psoriasis has been demonstrated in several clinical trials , but information regarding results derived from prospect i ve observational studies in clinical practice is scarce . Objectives : To evaluate the efficacy and safety of etanercept administration according to routine clinical use in moderate-to-severe plaque psoriasis . Material s and Methods : Postauthorization , prospect i ve study , carried out at 59 dermatology units in Spain . Patients diagnosed with moderate-to-severe plaque psoriasis received etanercept during a 12-month period . Results : Altogether , 444 patients were enrolled . Overall , 325 patients ( 73.2 % ) initiated etanercept treatment at a dose of 50 mg twice weekly ; 96 patients ( 21.6 % ) received etanercept as a continuous regimen for the entire study period , and 348 patients ( 79.4 % ) an intermittent regimen . Among these , 185 patients ( 41.6 % overall ) received one course of treatment , stopped at various study points and did not restart etanercept treatment , whereas the remaining 163 patients ( 36.7 % overall ) stopped etanercept treatment , lost response , relapsed and were retreated . Most patients who interrupted etanercept treatment did so at month 6 . Altogether , 79.7 % of patients completed the study period . Etanercept treatment result ed in significant improvement in disease activity . A Psoriasis Area and Severity Index ( PASI ) 75 response was achieved by 76.1 % of patients at month 6 . Out of 252 adverse events reported , 31 were considered severe . Three possibly treatment-related malignancies were detected during the study . No opportunistic infections , tuberculosis or demyelinating events were reported . Conclusion : The PASI 75 response rate at month 6 in this observational , naturalistic study is similar to those observed in recent published trials with etanercept , and within the range of those reported for other marketed biologicals BACKGROUND Approximately 20 - 30 % of patients with psoriasis treated with anti-tumour necrosis factor α ( TNFα ) agents  will discontinue treatment within 2 years due to loss of efficacy or side-effects . Switching to another anti-TNFα agent produces clinical responses inferior to previously untreated patients . Ustekinumab binds to the p40 subunit of interleukin (IL)-12 and IL-23 and provides a mechanism of action independent of TNFα . OBJECTIVE To investigate the efficacy of ustekinumab in a clinical practice setting and to compare treatment responses to ustekinumab in patients previously treated with TNFα inhibitors and anti-TNFα-naïve patients . METHODS Patients receiving either ustekinumab ( n=71 ) or the subcutaneous TNFα inhibitors adalimumab or etanercept ( n=108 ) were identified through the registry of psoriasis patients in our Institutions . Efficacy effect outcome was a 75 % improvement in the psoriasis area severity index ( PASI75 ) . Kaplan-Meier statistics evaluated the adherence to the treatments expressed as drug survival rate . RESULTS PASI75 was achieved in 80 % of the ustekinumab-treated patients after a median time of 112 days . There was no difference in efficacy in anti-TNFα-naïve patients compared with anti-TNFα unresponsive patients . Patients treated with ustekinumab showed a superior adherence to treatment in comparison with adalimumab and etanercept . LIMITATIONS Patients were non-r and omly assigned to treatment , which potentially may lead to biases . Observation time was short ( 1 year ) . CONCLUSION In clinical practice , the short-term efficacy and patient adherence to ustekinumab are excellent and comparable to the data obtained in clinical trials . Lack of response to previous anti-TNF treatment does not impair clinical response to ustekinumab Background : Since the beginning of 2005 , etanercept and efalizumab are officially registered and reimbursed for the treatment of  recalcitrant psoriasis in The Netherl and s. Objective : The evaluation of the efficacy , safety and adverse events of etanercept and efalizumab treatment in daily practice . Methods : A prospect i ve cohort study was carried out for patients treated with etanercept or efalizumab between February 2005 and March 2006 . Results : Over the past 13 months 45 individuals were treated with etanercept and 17 subjects were treated with efalizumab . The cohort represented a high‐need population . At week 12 , 82 % of the subjects treated with 2 × 50 mg etanercept/week and 71 % of the subjects treated with 2 × 25 mg etanercept/week  reached a PASI‐50 . Efficacy  of etanercept treatment was comparable to the results of clinical trials . For efalizumab  , efficacy in responding patients was also comparable to clinical trial data , but the percentage of dropouts was substantial . During biologic treatment , safety was preserved and mainly mild adverse events were reported . Conclusion : Etanercept and efalizumab are effective and safe treatments of psoriasis , even in a high‐need population  . Etanercept was able to sustain the clinical improvement throughout 24 weeks , whereas efalizumab was not in 47 % of subjects Background Knowledge on the sequential treatment of psoriasis with biologics with regard to efficacy and safety is sparse . This also applies to the efficacy and safety of adalimumab in patients previously treated with etanercept . The relationship between the reasons for discontinuation of etanercept and the response to adalimumab is not clear in psoriasis
The efficacy of biologic or conventional systemic therapies for psoriasis has been shown in r and omized controlled trials .
Effectiveness , however , has been studied in daily practice cohorts , and no aggregation of effectiveness data is available .