Psoriasis patients with psoriasis Area and Severity Index (PASI) 90 response achieve greater health-related quality-of-life improvements than those with PASI 75–89 response: results from two phase 3 studies of secukinumab

Elewski, Boni E.; Puig, L.; Mordin, Margaret; Gilloteau, I.; Sherif, Bintu; Fox, Todd; Gnanasakthy, Ari; Papavassilis, Charis; Strober, Bruce

doi:10.1080/09546634.2017.1294727

Cited by 49 publications

(44 citation statements)

References 27 publications

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“…To our knowledge, all previous research investigating the relationship between HRQoL and skin clearance per PASI percentage responder group is from a clinical trial setting. Several RCTs report higher DLQI improvements in PASI 90<100 patients compared with PASI 75<90 patients . We found no studies reporting DLQI or EQ‐5D response at different levels of PASI percentage response from a clinical practice setting.…”

Section: Discussionmentioning

confidence: 69%

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: Discussionmentioning

confidence: 69%

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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“…In efficacy evaluation of each drug for psoriasis, the algorithm has been proposed that switching to other drugs should be considered for patients not achieving PASI‐50 or for patients showing improvements corresponding to 50 ≤ PASI < 75 and DLQI scores of more than 5. However, with recent advances in trials for the development of biologics, there is an opinion that PASI‐90 and a DLQI score of 0 or 1 (DLQI remission) should be set as treatment goals rather than PASI‐75 and DLQI scores of ≤5 While biologics available for psoriasis are increasing, switching from a biologic to another biologic, namely bio‐switch, has been frequently performed due to secondary failure (therapeutic effects observed for a certain period subsequently decrease and symptoms worsen during continuous treatment), adverse reactions, patients’ requests or other reasons.…”

Section: Eligible Patients For Treatment With Biologicsmentioning

confidence: 99%

“…However, with recent advances in trials for the development of biologics, there is an opinion that PASI-90 and a DLQI score of 0 or 1 (DLQI remission) should be set as treatment goals rather than PASI-75 and DLQI scores of ≤5. 79 • While biologics available for psoriasis are increasing, switching from a biologic to another biologic, namely bio-switch, has been frequently performed due to secondary failure (therapeutic effects observed for a certain period subsequently decrease and symptoms worsen during continuous treatment), adverse reactions, patients' requests or other reasons. It has been demonstrated that, even in patients previously treated with biologics and in patients responding inadequately to previous biologics, most newly approved biologics can be expected to be effective to a certain extent.…”

Section: Selection Criteria Of Biologicsmentioning

confidence: 99%

Japanese guidance for use of biologics for psoriasis (the 2019 version)

Saeki

Terada

Morita

et al. 2020

The Journal of Dermatology

109

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As the first biologics for psoriasis in Japan, infliximab and adalimumab, anti‐tumor necrosis factor‐α antibodies, became available in the field of dermatology in 2010, followed by ustekinumab, an anti‐interleukin (IL)‐12/IL‐23p40 antibody, which was launched in Japan in 2011. Since 2015, three IL‐17 inhibitors of secukinumab and ixekizumab, anti‐IL‐17A antibodies, and brodalumab, an anti‐IL‐17 receptor antibody, and two anti‐IL‐23p19 antibodies of guselkumab and risankizumab, have also been launched. It is important for physicians to select appropriate biologic therapy for each psoriatic patient after due consideration of disease factors, treatment factors and patient background factors, sharing such information with patients. The following can be listed as points to be considered for the selection of biologics: drug effects (e.g. strength of effectiveness, time to onset of effectiveness, effectiveness against arthritis, primary failure, secondary failure), safety (e.g. infections, administration‐related reactions and relationships with other comorbidities), convenience for patients (e.g. hospital visit intervals, self‐injection, maintenance therapy at clinics, feasibility of drug discontinuation/re‐administration) and payment (medical costs) borne by patients. This guidance has been prepared with the aim of allowing dermatologists experienced in the treatment of psoriasis to use biologics appropriately according to the circumstances of individual patients after consideration of the above‐mentioned factors.

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“…Meanwhile, Torii et al [42] in their study on infliximab considered that a PASI 90 response is necessary to achieve a treatment goal stated in the European S3 guidelines: a DLQI of 0 or 1 (no effect on patient’s QoL). More recently Elewski et al [43] in a study on secukinumab have shown that psoriatic patients with a PASI 90 response achieve greater health-related QoL improvements than those with a PASI 75–89 response and concluded that PASI 90–100 is a relevant therapeutic goal in moderate-to- severe psoriasis. Abrouk et al [44] found a statistically significant difference in DLQI scores between the patients on adalimumab achieving PASI 75 and the patients achieving PASI 90 at week 24, but not at week 12, and did not find a statistically significant difference in DLQI between the patients on ustekinumab achieving PASI 75 and the patients achieving PASI 90 at week 24.…”

Section: Hrqol Assessment In Dermatological Guidelinesmentioning

confidence: 99%

The Evolution of Quality of Life Assessment and Use in Dermatology

Chernyshov¹

2019

Dermatology

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The creation of the Dermatology Life Quality Index (DLQI) questionnaire facilitated many studies on the impact of skin diseases on patients’ quality of life (QoL). Many national and international guidelines recommend QoL assessment in dermatology, and some of them contain detailed recommendations on treatment goals and changes of treatment approaches based on DLQI score banding and minimal clinically important difference. The methodology of QoL in strument development and validation is constantly becoming more rigorous. Initiatives on selection of core outcome sets for skin diseases are focused on clinical trials but may also be beneficial for clinicians. There are various benefits of using QoL information in clinical practice, but experience of this is very limited at the moment. QoL assessment in dermatology is a rapidly developing field with a gradual shift from theory to practice.

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Psoriasis patients with psoriasis Area and Severity Index (PASI) 90 response achieve greater health-related quality-of-life improvements than those with PASI 75–89 response: results from two phase 3 studies of secukinumab

Abstract: These results show that PASI 90-100 is a relevant therapeutic goal in moderate to severe psoriasis compared to PASI 75-89 when considering patients' QOL.

Cited by 49 publications

References 27 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

Japanese guidance for use of biologics for psoriasis (the 2019 version)

The Evolution of Quality of Life Assessment and Use in Dermatology

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