Spanish Evidence-Based Guidelines on the Treatment of Psoriasis With Biologic Agents, 2013. Part 1: On Efficacy and Choice of Treatment

Puig, Lluís; Carrascosa, J.M.; Carretero, G.; Cueva, Pablo de la; Lafuente-Urrez, R.F.; Belinchón, Isabel; Sánchez‐Regaña, M.; García‐Bustínduy, M.; Ribera, M.; Alsina, M.; Ferrándiz, Carlos; Fonseca, Eduardo; García‐Patos, Vicente; Herrera, Enrique; López-Estebaranz, J.L.; Marrón, S.E.; Moreno, J.C.; Notario, J.; Rivera, R.; Rodríguez-Cerdeira, Carmen; Romero, A.; Ruiz‐Villaverde, Ricardo; Taberner, R.; Vidal, David

doi:10.1016/j.adengl.2013.04.013

Cited by 43 publications

(38 citation statements)

References 107 publications

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“…Thresholds based on absolute PASI levels may be more relevant. This is in accordance with some recent treatment guidelines, which have suggested an absolute PASI < 3 as a relevant treatment goal in clinical practice …”

Section: Discussionsupporting

confidence: 92%

Complete skin clearance and Psoriasis Area and Severity Index response rates in clinical practice: predictors, health‐related quality of life improvements and implications for treatment goals

et al. 2019

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Summary Background Psoriasis Area and Severity Index (PASI) 90 is suggested to be the new standard endpoint for randomized controlled trials of biologics for psoriasis, whereas treatment guidelines often still refer to PASI 75. Objectives To analyse in a real‐world setting: firstly, what factors are associated with higher levels of treatment response to biologics; secondly, the health‐related quality of life gains associated with different response levels in clinical practice. Methods Biologically naïve patients with PASI, Dermatology Life Quality Index (DLQI) and EuroQol (EQ)‐5D outcomes before (maximum 6 months) and after (3–12 months) switch to biologics during registration in the Swedish National Registry for Systemic Treatment of Psoriasis (PsoReg) were included (n = 515). Patient characteristics associated with higher treatment response were analysed by regression analyses. Improvements in absolute PASI, DLQI and EQ‐5D were assessed in different PASI percentage response levels. Results High PASI percentage response was associated with higher PASI before switch and lower body mass index. DLQI and EQ‐5D improved within all responder groups (P < 0·001). The magnitude of improvements in DLQI (P = 0·02) differed between responder groups. The mean (SD) DLQI improvements for PASI 75<90 responders, PASI 90<100 responders and patients achieving complete skin clearance (PASI 100) were 9·9 (7·4), 11·5 (7·0) and 8·0 (6·1), respectively. Conclusions PASI percentage change is largely dependent on absolute PASI before switch. Patients in clinical practice lack ‘baseline’ PASI values as they may switch directly from one treatment to another or stay successfully treated for a longer time period. Treatment goals such as PASI 90 are thus not suitable for treatment guidelines or for follow‐up in clinical practice. What's already known about this topic? Randomized clinical trials of biologics as well as treatment guidelines include treatment goals based on a percentage improvement compared with baseline Psoriasis Area and Severity Index (PASI), such as PASI 75 or PASI 90. Few studies have assessed which factors are associated with high skin clearance rates, or health‐related quality of life (HRQoL) improvements associated with different levels of skin clearance in clinical practice. What does this study add? A high absolute PASI before switch to biologics and low body mass index are associated with higher PASI percentage response. Few patients with baseline PASI >30 achieved complete skin clearance (CSC). All responder groups achieved significant HRQoL improvements. Patients achieving CSC (PASI 100) had lower absolute PASI before switch and lower improvements in absolute PASI and HRQoL than patients with almost cleared skin. What are the clinical implications of this work? Relative measures based on PASI percentage, such as PASI 75 or PASI 90, are not suitable for treatment guidelines or for follow‐up in clinical practice.

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Section: Discussionsupporting

confidence: 92%

Complete skin clearance and Psoriasis Area and Severity Index response rates in clinical practice: predictors, health‐related quality of life improvements and implications for treatment goals

et al. 2019

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“…Another study found discrepancies between DLQI scores and time trade‐off utility values, suggesting that HRQoL in two patients with identical DLQI scores might be significantly different, while patients whose DLQI scores differ larger than the minimal clinically important difference may be equal . Considering the number of jurisdictions, in which the DLQI is used in national guidelines, including the European S3‐Guidelines on the systemic treatment of psoriasis vulgaris, the amount of patients affected worldwide may be very large. Our results, taken together with other findings in the literature, suggest that the applicability of the DLQI in the management of psoriasis patients may be called into question.…”

Section: Discussionmentioning

confidence: 99%

A detailed analysis of ‘not relevant’ responses on the DLQI in psoriasis: potential biases in treatment decisions

Rencz

Poór

Péntek

et al. 2017

Acad Dermatol Venereol

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“…‘Adequate response' or therapeutic goal was defined as achieving and maintaining a PASI75 response or an absolute PASI value below 5 [8]. In order to achieve this goal, dosing intervals were temporarily reduced (dose intensification) in 10 patients, and/or combination therapy with systemic agents was prescribed at some time in 18 patients.…”

Section: Methodsmentioning

confidence: 99%

Long-Term Efficacy, Safety and Drug Survival of Ustekinumab in a Spanish Cohort of Patients with Moderate to Severe Plaque Psoriasis

Puig¹,

Ruiz‐Salas²

2015

Dermatology

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Objective: To investigate the efficacy and safety of ustekinumab in clinical practice and the influence of several variables on response rates as well as on drug survival. Methods: Retrospectively collected efficacy and safety data of a cohort of 67 consecutive patients treated with ustekinumab for moderate to severe psoriasis for at least 28 weeks and a maximum of 3 years. Drug survival was analyzed by the Kaplan-Meier method with log-rank test. Results: PASI75 response rates were numerically higher in patients treated with 45 mg and patients naïve to tumor necrosis factor (TNF)-blocking agents, at all time points. Drug survival was not significantly affected by any variable. Conclusion: Male sex, weight >100 kg, obesity, and previous failure of one or more TNF inhibitors were associated with a diminished response to treatment. Obesity or previous exposure to anti-TNF agents was not associated with a diminished drug survival in this Spanish cohort.

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Spanish Evidence-Based Guidelines on the Treatment of Psoriasis With Biologic Agents, 2013. Part 1: On Efficacy and Choice of Treatment

Cited by 43 publications

References 107 publications

Complete skin clearance and Psoriasis Area and Severity Index response rates in clinical practice: predictors, health‐related quality of life improvements and implications for treatment goals

Complete skin clearance and Psoriasis Area and Severity Index response rates in clinical practice: predictors, health‐related quality of life improvements and implications for treatment goals

A detailed analysis of ‘not relevant’ responses on the DLQI in psoriasis: potential biases in treatment decisions

Long-Term Efficacy, Safety and Drug Survival of Ustekinumab in a Spanish Cohort of Patients with Moderate to Severe Plaque Psoriasis

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