Real‐world evidence from the non‐interventional, prospective, German multicentre <scp>PERSIST</scp> study of patients with psoriasis after 1 year of treatment with guselkumab

Gerdes, Sascha; Asadullah, Khusru; Hoffmann, Matthias; Korge, Bernhard; Mortazawi, Dariusch; Wegner, Sven; Personke, Yvonne; Gomez, Mario; Sticherling, Michael

doi:10.1111/jdv.18218

Cited by 12 publications

(8 citation statements)

References 36 publications

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“…7 In a prospective, non-interventional and multi-center German PERSIST study analyzing 303 psoriasis patients undergoing guselkumab treatment, the overall drug survival at week 52 was 92.4%. 9 While guselkumab trended towards increased drug survival relative to ixekizumab and secukinumab, there were no significant differences in these three drug survival rates. However, other studies have alternatively reported that secukinumab and guselkumab exhibit higher rates of drug survival (90% vs 88%) relative to ixekizumab (82%).…”

Section: Discussionmentioning

confidence: 90%

Drug Survival Outcomes Associated with the Real-World Use of Ixekizumab, Secukinumab, Guselkumab, and Adalimumab for the Treatment of Plaque Psoriasis in China: A 52-Week Single-Center Retrospective Study

Liu¹,

Lu²,

Zhong³

et al. 2022

CCID

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Background: Data pertaining to biologic agents used for treating psoriasis in real-world settings are lacking at present. To compare drug survival at 52 weeks for a range of biologics used to treat psoriasis under real-world conditions. Methods: This was a retrospective, single-center, observational study of a cohort of patients diagnosed with plaque psoriasis treated using ixekizumab, secukinumab, guselkumab, or adalimumab between January 2020 and December 2021. Baseline demographic characteristics, duration of psoriasis, and prior biological treatments for all patients were recorded. Drug survival rates were analyzed in different patient groups using Kaplan-Meier curves and Log rank tests. Results: In total, this study included 386 plaque psoriasis patients, of whom 70, 175, 36, and 105 were, respectively, treated using ixekizumab, secukinumab, guselkumab, and adalimumab. Over a 52-week period, the overall cumulative drug survival rates for ixekizumab, secukinumab, guselkumab, and adalimumab were 67.1%, 63.0%, 72.2%, and 37.1%, respectively. Lack of efficacy was the primary cause of discontinuation for these biologic therapies, followed by economic burden and adverse event incidence. Conclusion: These results suggest that guselkumab exhibited superior drug survival, drug survival outcomes for ixekizumab and secukinumab were comparable, and significantly better than those of adalimumab in China. Preventing a loss of drug efficacy represents a primary approach to improving biologic drug survival in psoriasis patients.

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Section: Discussionmentioning

confidence: 90%

Drug Survival Outcomes Associated with the Real-World Use of Ixekizumab, Secukinumab, Guselkumab, and Adalimumab for the Treatment of Plaque Psoriasis in China: A 52-Week Single-Center Retrospective Study

Liu¹,

Lu²,

Zhong³

et al. 2022

CCID

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“…The PASI 75 and PASI 90 response rates reported for the other IL-23p19 inhibitors, guselkumab and risankizumab, in real-life settings appear consistent with those observed in this study with TIL. [37][38][39][40][41][42] Likewise, recent real world evidence studies reporting PASI response rates for all three IL-23p19 inhibitors from the same cohort have found very similar effectiveness. 35,43 In addition to the DLQI questionnaire, the Skindex-16 measure was utilized in the TRIBUTE study to comprehensively assess the impact on HRQoL.…”

Section: System Organ Class Term Preferred Termmentioning

confidence: 97%

Tildrakizumab improves high burden skin symptoms, impaired sleep and quality of life of moderate‐to‐severe plaque psoriasis patients in conditions close to clinical practice

Costanzo

Llamas‐Velasco

Fabbrocini

et al. 2023

Acad Dermatol Venereol

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BackgroundTildrakizumab (TIL) is an interleukin (IL)‐23p19 inhibitor for the treatment of moderate‐to‐severe plaque psoriasis with long‐term efficacy and safety demonstrated in Phase III trials. Studies conducted in conditions closer to clinical practice are needed.ObjectivesThe TRIBUTE study (open‐label, Phase IV) assessed the efficacy and impact on health‐related quality of life (HRQoL) of TIL 100 mg in adult moderate‐to‐severe psoriasis patients (naïve to IL‐23/Th17 pathway inhibitors) in conditions similar to clinical practice.MethodsKey efficacy measure was Psoriasis Area Severity Index (PASI). HRQoL was evaluated using the Dermatology Life Quality Index (DLQI) and Skindex‐16. Additional patient‐reported outcomes included Pain‐, Pruritus‐ and Scaling‐Numerical Rating Scale (NRS), Medical Outcome Study (MOS)‐Sleep, Work Productivity and Activity Impairment (WPAI), Patient Benefit Index (PBI) and Treatment Satisfaction Questionnaire for Medication (TSQM).ResultsOne hundred and seventy‐seven patients were enrolled (six patients did not complete the study). After 24 weeks, the proportion of patients achieving PASI scores ≤ 3, PASI 75, PASI 90 and DLQI 0/1 was 88.4%, 92.5%, 74.0% and 70.4%, respectively. Skindex‐16 overall score improved (mean absolute change from baseline, MACB [95%CI]: −53.3 [−58.1, −48.5]). Significant benefits (MACB [95%CI]) were found on pruritus‐, pain‐ and scaling‐NRS scores (−5.7 [−6.1, −5.2], −3.5 [−4.1, −3.0] and −5.7 [−6.2, −5.2], respectively), MOS‐Sleep (−10.4 [−13.3, −7.4] Sleep problems Index II) and WPAI (−36.4 [−42.6, −30.2] activity impairment, −28.2 [−34.7, −21.7] productivity loss, −27.0 [−32.9, −21.1] presenteeism and −6.8 [−12.1, −1.5] absenteeism). 82.7% of patients reported PBI ≥ 3 and the mean (SD) global TSQM score was high (80.5 [18.5]). Only one serious treatment‐emergent adverse event was reported (not‐related to TIL).ConclusionsTIL 100 mg treatment after 24 weeks in conditions close to real clinical practice showed a quick and high improvement in psoriasis signs and HRQoL. Patient reported improvements in sleep outcomes and work productivity, relevant benefits and high treatment satisfaction. The safety profile was favourable and consistent with Phase III trials.

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“…Summary drug survival curves in blue, separate studies in grey. A Secukinumab [ 24 – 26 , 33 , 34 , 39 – 41 , 44 , 46 , 48 , 50 , 51 , 53 , 62 , 64 , 68 , 70 , 72 , 74 , 80 – 85 ], B ixekizumab [ 23 , 32 , 33 , 39 , 40 , 42 – 44 , 46 , 49 , 62 , 70 , 81 , 84 , 85 ], C brodalumab [ 39 , 40 , 58 , 62 , 84 – 87 ], D guselkumab [ 29 , 30 , 33 , 35 , 37 , 43 , 44 , 50 , 59 , 70 , 84 , 85 , 88 , 89 ], E risankizumab [ 27 , 50 , 84 , 85 , 90 ], ...…”

Section: Resultsmentioning

confidence: 99%

Drug Survival of IL-17 and IL-23 Inhibitors for Psoriasis: A Systematic Review and Meta-Analysis

Thomas,

Barenbrug,

Hannink

et al. 2024

Drugs

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Background and Objective The most recently approved biologics for moderate-to-severe psoriasis are the interleukin (IL)-17 and IL-23 inhibitors. Drug survival is a frequently used outcome to assess drug performance in practice. An overview of the available drug survival studies regarding IL-17 and IL-23 inhibitors is lacking. Therefore, our objective was to assess the drug survival of IL-17 and IL-23 inhibitors for psoriasis. Methods A search of PubMed, Embase, Cochrane Library and Web of Science was conducted (last search 27 December, 2023). Inclusion criteria were (1) cohort study; (2) patients aged ≥ 18 years with plaque psoriasis; and (3) evaluation of drug survival of at least one of the IL-17 and IL-23 inhibitors. Exclusion criteria were: primary focus on patients with psoriatic arthritis, fewer than ten study subjects and another language than English. The Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline was followed. Survival probabilities at monthly intervals were extracted from Kaplan–Meier curves using a semi-automated tool. Data were pooled using a non-parametric random-effects model to retrieve distribution-free summary survival curves. Summary drug survival curves were constructed per biologic for different discontinuation reasons: overall, ineffectiveness and adverse events, and split for the effect modifier biologic naivety. Results were analysed separately for registry/electronic health record data and for pharmacy/claims data. Results A total of 69 studies aggregating drug survival outcomes of 48,704 patients on secukinumab, ixekizumab, brodalumab, guselkumab, risankizumab, and tildrakizumab were included. Summary drug survival estimates of registry/electronic health record studies for overall, ineffectiveness and adverse event related drug survival were high (all point estimates ≥ 0.8 at year 1) for included biologics, with highest estimates for guselkumab and risankizumab. All estimates for drug survival were higher in biologic naive than in experienced patients. Estimates of pharmacy/claims databases were substantially lower than estimates from the primary analyses based on registry/electronic health record data. Conclusions This meta-analysis showed that the investigated IL-17 and IL-23 inhibitors had high drug survival rates, with highest rates for guselkumab and risankizumab drug survival. We showed that effect modifiers such as biologic naivety, and the source of data used (registry/electronic health record data vs pharmacy/claims databases) is relevant when interpreting drug survival studies. Supplementary Information The online version contains supplementary material available at 10.1007/s40265-024-02028-1.

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Real‐world evidence from the non‐interventional, prospective, German multicentre PERSIST study of patients with psoriasis after 1 year of treatment with guselkumab

Cited by 12 publications

References 36 publications

Drug Survival Outcomes Associated with the Real-World Use of Ixekizumab, Secukinumab, Guselkumab, and Adalimumab for the Treatment of Plaque Psoriasis in China: A 52-Week Single-Center Retrospective Study

Drug Survival Outcomes Associated with the Real-World Use of Ixekizumab, Secukinumab, Guselkumab, and Adalimumab for the Treatment of Plaque Psoriasis in China: A 52-Week Single-Center Retrospective Study

Tildrakizumab improves high burden skin symptoms, impaired sleep and quality of life of moderate‐to‐severe plaque psoriasis patients in conditions close to clinical practice

Drug Survival of IL-17 and IL-23 Inhibitors for Psoriasis: A Systematic Review and Meta-Analysis

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