Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM): A Novel Patient-Reported Outcome Instrument for Patients with Plaque Psoriasis, Using Reported Data from the BE RADIANT Phase 3b Trial

Gottlieb, Alice B.; Warren, Richard B.; Augustin, Matthias; Garcia, Llenalia; Cioffi, Christopher; Peterson, Luke; Pelligra, C.; Ciaravino, Valerie

doi:10.1007/s12325-021-01836-1

Cited by 6 publications

(5 citation statements)

References 17 publications

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“… 3 , 4 Data from 3 phase III, multicenter, randomized, double-blind, placebo-, and comparator-controlled clinical trials (BE READY, BE SURE, BE VIVID, BE RADIANT) have been published to date, showing bimekizumab superior efficacy over adalimumab, ustekinumab, and secukinumab. 9 , 10 , 11 , 12 There are data regarding the efficacy of bimekizumab for scalp psoriasis also in clinical trials. In particular, BE VIVID, a 52-week, phase 3, randomized, ustekinumab, and placebo-controlled study included, among the efficacy end points, scalp Investigator’s Global Assessment (IGA) 0/1 response at week 16 in patients with scalp psoriasis at baseline (baseline scalp IGA score of ≥2).…”

Section: Discussionmentioning

confidence: 99%

A case of scalp psoriasis resistant to ixekizumab treated with bimekizumab

Megna¹,

Picone²,

Ventura³

et al. 2023

JAAD Case Reports

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Section: Discussionmentioning

confidence: 99%

A case of scalp psoriasis resistant to ixekizumab treated with bimekizumab

Megna¹,

Picone²,

Ventura³

et al. 2023

JAAD Case Reports

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“…In general, terms such as little or mild are considered to be small enough to represent a minimal difference. To avoid discussion around the word minimal , some authors prefer the terms clinically important or meaningful …”

Section: Discussionmentioning

confidence: 99%

Credibility and Generalization of the Minimally Important Difference Concept in Dermatology

et al. 2022

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ImportanceThe minimally important difference (MID) represents the point at which a difference in an outcome measure (eg, Dermatology Life Quality Index) is important enough that it warrants a change in treatment, and, to the authors’ knowledge, the robustness and limitations of MIDs have not been thoroughly evaluated in skin diseases. The MID is increasingly used in clinical trials to demonstrate that an intervention is worthwhile for patients; furthermore, MIDs also contribute to sample size calculations in clinical trials, influence treatment guidelines, and can guide clinicians to modify treatment.ObjectiveTo evaluate the credibility and generalization of MIDs for patient-reported outcome measures (PROMs) in skin disorders.Evidence ReviewA systematic search was conducted in PubMed and Embase for all original articles using the MID concept for skin disorders from inception to December 29, 2021. The credibility of MIDs obtained via an anchor-based approach (eg, global rating of change scale) was assessed with a previously developed credibility instrument. The validity of generalizing established MIDs to other patient groups was evaluated based on the diagnosis and the patient characteristics.FindingsA total of 126 articles were selected, and 84 different MIDs were identified for PROMs. A total of 13 of 84 MIDs (15.5%) for PROMs displayed acceptable credibility. The anchors used had varying capacity to assess minimal important changes from a patient’s perspective and were deemed inappropriate for this purpose in 52 of 84 cases (61.9%). Correlations between the anchors and PROMs were frequently not determined (39 of 84; 46.4%). The time interval for anchor questions assessing a change in the experienced disease burden was not optimal for 10 of 32 transition anchors (&gt;3 months), introducing potential recall bias. Previously reported MIDs were widely used to examine relevant changes in other study populations. However, the diagnosis and disease severity were different from the original MID population in 39 of 70 (55.7%) and 45 of 70 (64.3%) cases, respectively.Conclusions and RelevanceIn this scoping review, only a minority of MIDs for PROMs demonstrated sufficient credibility in dermatology. Inappropriate generalization of previously reported MIDs to patient populations with different disease characteristics was found to be a major concern. Furthermore, the study supported the use of multiple anchors and encouraged consistent reporting of the correlation between changes in the anchor and changes in the outcome measures.

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“…7 Data from three Phase III, multicenter, randomized, double-blind, placebo-and comparator-controlled clinical trials showed bimekizumab superior efficacy over adalimumab, ustekinumab, and secukinumab. [8][9][10] In all phase 3 trials, bimekizumab was also well tolerated, with a safety profile similar to the other biologic drugs tested, except for a higher frequency of oral candidiasis. [8][9][10] To date, no real-life experiences or case series regarding bimekizumab for psoriasis are available in literature, due to its very recent approval.…”

mentioning

confidence: 88%

“…[8][9][10] In all phase 3 trials, bimekizumab was also well tolerated, with a safety profile similar to the other biologic drugs tested, except for a higher frequency of oral candidiasis. [8][9][10] To date, no real-life experiences or case series regarding bimekizumab for psoriasis are available in literature, due to its very recent approval. We herein present the first case of EP successfully and rapidly treated with bimekizumab, reaching PASI100 already at Week 4 maintaining response up to Week 12.…”

mentioning

confidence: 88%

A case of erythrodermic psoriasis rapidly and successfully treated with Bimekizumab

Megna

Battista

Potestio

et al. 2022

J of Cosmetic Dermatology

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Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM): A Novel Patient-Reported Outcome Instrument for Patients with Plaque Psoriasis, Using Reported Data from the BE RADIANT Phase 3b Trial

Abstract: Introduction: This analysis assessed the psychometric properties of the Psoriasis Symptoms and Impacts Measure (P-SIM), a novel patientreported outcome (PRO) tool designed to

Cited by 6 publications

References 17 publications

A case of scalp psoriasis resistant to ixekizumab treated with bimekizumab

A case of scalp psoriasis resistant to ixekizumab treated with bimekizumab

Credibility and Generalization of the Minimally Important Difference Concept in Dermatology

A case of erythrodermic psoriasis rapidly and successfully treated with Bimekizumab

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