Predictive factors of lack of response to adalimumab among bio-naive patients suffering from moderate-to severe psoriasis: analysis of a multicenter data collection in Italy

Zangrilli, Arianna; Caldarola, Giacomo; Bernardini, Nicoletta; Bavetta, Mauro; Graceffa, Dario; Bonifati, C.; Cantoresi, Franca; Faleri, Sara; Giordano, Domenico; Mariani, Marco; Micheli, Adriana; Moretta, Gaia; Pirrò, Federico; Pagnanelli, Gianluca; Panasiti, Vincenzo; Provini, Alessia; Richetta, Antonio Giovanni; Sacchelli, Lidia; Bianchi, Luca; Peris, Ketty

doi:10.1080/14712598.2021.1948530

Cited by 7 publications

(6 citation statements)

References 16 publications

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“…In our opinion, our findings are worthy of note because various studies have shown that several categories of patients, such as obese, bio‐experienced and those with high PASI at baseline, have a very low probability to achieve a consistent clinical improvement with numerous molecules, in particular with anti TNF agents 18–25 . These are the first class of biologics approved for the treatment of moderate‐to‐severe chronic plaque psoriasis and, in the last years, after the approval of their biosimilars, they are often recommended as first‐line treatment of choice for psoriatic patients, based upon economic reasons.…”

Section: Discussionmentioning

confidence: 63%

“…Interestingly, this is in line with a previous study by Gkalpakiotis et al 9 In our opinion, our findings are worthy of note because various studies have shown that several categories of patients, such as obese, bio-experienced and those with high PASI at baseline, have a very low probability to achieve a consistent clinical improvement with numerous molecules, in particular with anti TNF agents. [18][19][20][21][22][23][24][25] These are the first class of biologics approved for the treatment of moderate-tosevere chronic plaque psoriasis and, in the last years, after the approval of their biosimilars, they are often recommended as first-line treatment of choice for psoriatic patients, based upon economic reasons. Then, taking into account our data that have confirmed the effectiveness of risankizumab in all categories of patients, we suggest that starting with this drug or with other non-antiTNF drugs with similar real-life data might be advisable in those "high-need" categories of patients who have a high probability to be unresponsive to anti-TNF agents.…”

Section: Discussionmentioning

confidence: 99%

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Risankizumab for the treatment of moderate‐to‐severe psoriasis: A multicenter, retrospective, 1 year real‐life study

Caldarola

Zangrilli

Bernardini

et al. 2022

Dermatologic Therapy

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Several new biologic agents targeting IL23/Th17 axis, such as risankizumab, have been developed for the treatment of psoriasis. The aim of the present study was to analyze the efficacy and safety of risankizumab in patients with moderate-to-severe psoriasis over a 52-week period. A multicentric retrospective study was conducted in patients who initiated risankizumab between July 2019 and December 2020. Psoriasis Area and Severity Index-PASI was measured at baseline and after 4, 16, 28 and 52 weeks. Clinical responses were evaluated by PASI75, PASI90 and PASI100 at the same timepoints. Potential safety issues and adverse events (AEs) were collected.Univariable and multivariable logistic regressions were performed for variables predicting clinical response. One hundred and twelve patients with psoriasis were included. PASI90 response was achieved by 17.86% of patients at week 4, 72.22% at week 16, 91.0% at week 28 and 95.24% at week 52 (as observed analysis). No associations between the considered variables and the efficacy endpoints were retrieved, influence of variables such as Body Mass Index (BMI), baseline PASI or previous biologics were not shown. No serious safety issues or discontinuations related to adverse events were reported. Risankizumab showed high efficacy and a favorable safety profile, regardless of patient-and disease-related factors.

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Section: Discussionmentioning

confidence: 63%

Section: Discussionmentioning

confidence: 99%

Risankizumab for the treatment of moderate‐to‐severe psoriasis: A multicenter, retrospective, 1 year real‐life study

Caldarola

Zangrilli

Bernardini

et al. 2022

Dermatologic Therapy

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“…Following the screening, 64 studies were eligible for full-text screening. Through the search method, 23 studies were included, while an additional 17 studies were included through reference lists. Nine RCTs and 31 observational studies (all cohort studies) were included.…”

Section: Resultsmentioning

confidence: 99%

Clinical Characteristics Associated With Response to Biologics in the Treatment of Psoriasis

Hjort,

Schwarz,

Skov

et al. 2024

JAMA Dermatol

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ImportanceClinical characteristics associated with treatment response to biologics in patients with psoriasis have never been systematically investigated.ObjectiveTo evaluate the association between patient clinical characteristics and the effectiveness of biologics in treating psoriasis.Data SourcesPubMed, Embase, and Web of Science were searched from their inception through April 2022. Studies in English language that reported response to biologic treatment at approved doses in patients with psoriasis in relation to their clinical characteristics were included. In addition, eligible studies were identified through a search of the reference lists of the included studies.Study SelectionWe only included studies that reported treatment outcomes as Psoriasis Area and Severity Index (PASI) 75 or PASI 90 after 12, 26, and/or 52 weeks of treatment. Both observational studies and randomized clinical trials (RCTs) were considered. Two independent authors conducted the screening process, and 107 studies were assessed for eligibility.Data Extraction and SynthesisThe Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines were followed. Relevant data were extracted independently by 2 authors. Data were pooled using random-effects models. RCTs and observational studies were pooled in separate analyses. Data were analyzed from June 1, 2023, to August 1, 2023.Main Outcomes and MeasuresThe primary outcome was PASI 90 at 26 weeks (6 months). Before data collection began, an investigation of the association between the main (and secondary) outcomes and several clinical characteristics was planned.ResultsOverall, 40 studies with a total of 21 438 patients were included. Older age (odds ratio [OR], 0.99; 95% CI, 0.98-1.00), previous exposure to biologics (OR, 0.44; 95% CI, 0.29-0.67), higher body mass index (BMI) (OR, 0.96; 95% CI, 0.94-0.99), previous smoking (OR, 0.81; 95% CI, 0.67-0.98), and current smoking (OR, 0.78; 95% CI, 0.66-0.91) were negatively associated with achieving PASI 90 at 6 months in observational studies. In RCTs, only BMI of 30 or higher was negatively associated with treatment response (PASI 90 at 3 months: OR, 0.57; 95% CI, 0.48-0.66).Conclusions and RelevanceThis meta-analysis found that patients with psoriasis who smoke or have a history of smoking, as well as those with previous exposure to biologics, older age, or higher BMI, exhibited poorer response to biologics in observational studies. However, it remains unclear whether these clinical characteristics influence treatment response differently for the different biologics available for psoriasis.

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“…Palmoplantar involvement is considered a difficult‐to‐treat site 11 and a negative predictor of response to treatment in patients with psoriasis 12,13 …”

Section: Discussionmentioning

confidence: 99%

“…Palmoplantar involvement is considered a difficult-to-treat site 11 and a negative predictor of response to treatment in patients with psoriasis. 12,13 Few data on the prevalence of PP in both sexes are also available to date. Based on data collected in a recent systematic review, 3 the prevalence of PP is slightly higher in the male population, and the most frequent subtype of the two variants was hyperkeratotic.…”

Section: Discussionmentioning

confidence: 99%

Drug survival of biologics and non‐biologics in patients affected by palmoplantar psoriasis: a “real‐world”, mono‐center experience

Caldarola,

Falco,

Calabrese

et al. 2023

Int J Dermatology

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BackgroundData on the treatment of palmoplantar psoriasis (PP) are very limited as these patients are often excluded from clinical trials. Moreover, this form of psoriasis is often resistant to treatment, making its clinical management complex.MethodsPrimary endpoint was to evaluate the clinical and demographic characteristics and the drug survival of both biological and non‐biological drugs in a population affected by PP. Secondary endpoint was to highlight any differences between the hyperkeratotic and pustular variant. We analyzed data from 233 psoriasis patients with palmoplantar involvement, with or without chronic plaque psoriasis. We performed a drug‐survival analysis with the aid of Kaplan‐Meier survival and a multivariate analysis to highlight the influence of certain variables on treatment persistence using a Cox regression model.ResultsThe drug‐survival analysis revealed that biologic drugs compared to non‐biologic drugs are associated with a higher persistence in treatment (59.73 vs. 43.56%); in particular, anti‐IL23 drugs were found to be the drugs with the best drug‐survival overall (67.94% of patients at 60 months are still on these drugs). Furthermore, our multivariate analysis shows that when compared with biological drugs, non‐biological drugs are associated with an increased risk of treatment discontinuation (HR = 1.95 [95% CI: 1.41–2.68], P = 0.001).ConclusionsOur study confirms the difficulty of treating PP and shows that biologic drugs are associated with longer persistence in treatment than non‐biologics in both PP's variants, not because of their higher effectiveness but because of their better safety profile.

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Predictive factors of lack of response to adalimumab among bio-naive patients suffering from moderate-to severe psoriasis: analysis of a multicenter data collection in Italy

Cited by 7 publications

References 16 publications

Risankizumab for the treatment of moderate‐to‐severe psoriasis: A multicenter, retrospective, 1 year real‐life study

Risankizumab for the treatment of moderate‐to‐severe psoriasis: A multicenter, retrospective, 1 year real‐life study

Clinical Characteristics Associated With Response to Biologics in the Treatment of Psoriasis

Drug survival of biologics and non‐biologics in patients affected by palmoplantar psoriasis: a “real‐world”, mono‐center experience

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