Treat-to-Target Approach for the Management of Patients with Moderate-to-Severe Plaque Psoriasis: Consensus Recommendations

Gisondi, Paolo; Talamonti, Marina; Chiricozzi, Andrea; Piaserico, Stefano; Amerio, Paolo; Balato, Anna; Bardazzi, Federico; Pinton, Piergiacomo Calzavara; Campanati, Anna; Cattaneo, Angelo; Dapavo, Paolo; Simone, Clara De; Dini, Valentina; Fargnoli, Maria Concetta; Flori, Maria Laura; Galluzzo, Marco; Guarneri, Claudio; Lasagni, Claudia; Loconsole, Francesco; Schiavo, Ada Lo; Malagoli, Piergiorgio; Malara, Giovanna; Mercuri, Santo Raffaele; Musumeci, Maria Letizia; Naldi, Luigi; Papini, Manuela; Parodi, Aurora; Potenza, Concetta; Prignano, Francesca; Rongioletti, Franco; Stingeni, Luca; Tiberio, Rossana; Venturini, Marina; Bianchi, Luca; Costanzo, Antonio; Cusano, Francesco; Girolomoni, Giampiero; Offidani, Anna Maria; Peris, Ketty

doi:10.1007/s13555-020-00475-8

Cited by 39 publications

(48 citation statements)

References 62 publications

(83 reference statements)

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“…Psoriasis, psoriatic arthritis and hidradenitis suppurativa are three common inflammatory and immune-mediated skin diseases characterized by increased levels of pro-inflammatory cytokines and chemokines such as tumor necrosis factor (TNF)-a, interleukin (IL)-17 and IL-23 (1)(2)(3)(4)(5)(6)(7). Chemical inflammatory mediators involved in the pathogenesis of these diseases may increase the risk of malignancies through the induction of pro-cancerous mutations, adaptive responses, resistance to apoptosis and environmental changes such as the stimulation of angiogenesis (8,9).…”

Section: Introductionmentioning

confidence: 99%

Incidence of Skin Cancer in Patients With Chronic Inflammatory Cutaneous Diseases on Targeted Therapies: A Systematic Review and Meta-Analysis of Observational Studies

et al. 2021

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Cancer is one of the several comorbidities that have been linked with chronic cutaneous inflammatory diseases namely psoriasis/psoriatic arthritis and hidradenitis suppurativa. Although the chronic inflammatory state, typical of the diseases, may induce pro-tumorigenic effects, the debate whether or not the drugs currently used in clinical practice do in facts increase a patient’s risk of malignancy remains largely unsolved. The therapeutic armamentarium has been greatly enhanced at least in the last two decades with the advent of biologics, a heterogeneous group of laboratory-engineered agents with more in the pipeline, and other targeted small molecules. Among the organ systems, skin results as one of the most commonly affected, non-melanoma skin cancers being the main drug-induced manifestations as side effect in course of these treatments. The objective of the study is to systematically review the cutaneous malignancy risk of the newer therapies through an overview of meta-analyses and observational studies on the topic.

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Section: Introductionmentioning

confidence: 99%

Incidence of Skin Cancer in Patients With Chronic Inflammatory Cutaneous Diseases on Targeted Therapies: A Systematic Review and Meta-Analysis of Observational Studies

et al. 2021

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“…A study by Dey et al also reported greater improvements in vascular inflammation and atherosclerosis in psoriasis patients with more complete versus partial skin clearance following treatment [29]. With the emergence of biologics capable of achieving high levels of clearance, such advantages have become more evident, and treatment goals have shifted to reflect the importance of complete skin clearance [30,31]. In the current NMA, treatment of psoriasis with ixekizumab, an IL-17A inhibitor, led to the greatest amount of time with completely clear skin over the course of 1 year, corresponding to 23 weeks (44%) of the year.…”

Section: Discussionmentioning

confidence: 99%

Cumulative Clinical Benefits of Biologics in the Treatment of Patients with Moderate-to-Severe Psoriasis over 1 Year: a Network Meta-Analysis

Blauvelt

Gooderham

Griffiths

et al. 2022

Dermatol Ther (Heidelb)

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Introduction: Both early clinical improvement and long-term maintenance of clinical efficacy of treatments matter to patients with psoriasis. We compared cumulative clinical benefits of treatment with biologics over 1 year based on the area under the curve (AUC) for Psoriasis Area and Severity Index (PASI) 100 and PASI 90 responses in patients with moderate-to-severe psoriasis using a network meta-analysis (NMA). Methods: Published phase 3 randomized, placebo-or active-controlled clinical trial data for biologics approved for the treatment of moderate-to-severe psoriasis were obtained from a systematic literature review up to 30 September 2020. Eighteen clinical trials that included data from baseline to 48 or 52 weeks where AUC could be calculated were included. Data were compared using a fixed-effect model with a separate random-effect baseline model to account for effects of the placebo arm. Cumulative clinical benefit was estimated using the AUC for PASI 100 and PASI 90 responses (complete and almost-complete skin clearance, respectively). Normalized AUC was compared using Bayesian NMA. Cumulative days of response were calculated using normalized AUC and study duration. Results: Interleukin (IL)-17 and IL-23 inhibitors demonstrated greater cumulative clinical benefits for both PASI 100 and PASI 90 versus IL-12/ 23 and tumor necrosis factor inhibitors. Over 52 weeks, cumulative days with PASI 100 were greatest with ixekizumab [158.7 (95% credible interval, 147.4, 170.0) days] followed by risankizumab [154.0 (144.9, 163.4) days]; PASI 90 days were greatest with risankizumab [249.3 (239.5, 259.2) days] followed by ixekizumab [238.8 (227.1, 250.8) days]. Both ixekizumab

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“…Over the last 15 years, new biologicals raised progressively the therapeutic targets, from PASI 75 to PASI 90 and to absolute PASI less than 3. 31 Biologicals differ in their efficacy towards cutaneous disease and joint disease as well as in their safety profiles. According to a recent network analyses with head-to-head comparisons, anti-IL-17 and anti-IL-23 agents demonstrate higher cutaneous response rates than anti-TNF-α therapies and anti-IL-12/23 across multiple endpoints and over short-term and long-term follow-up.…”

Section: Discussionmentioning

confidence: 99%

Latest Advances for the Treatment of Chronic Plaque Psoriasis with Biologics and Oral Small Molecules

Bellinato

Gisondi

Girolomoni

2021

BTT

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Psoriasis is a common immune-mediated chronic skin disease. Disease severity is influenced by several factors including the extent and localization of skin lesions, severity of pruritus and comorbidities, such as psoriatic arthritis. Moderate to severe psoriasis is defined when cutaneous involvement is diffuse, covering more than 10% of the body surface areas and/or involving the sensitive areas such as face, genitalia, folds or nails or has high impact on patients’ quality of life, and it occurs in approximately 15% of cases. In recent years, a growing understanding of psoriasis pathophysiology allowed the development of an increasing number of effective and safe treatments, including biologicals that are indicated for moderate to severe psoriasis. Different classes of biologicals have been already approved, including TNF-α (etanercept, infliximab, adalimumab and certolizumab pegol), IL-12/23 (ustekinumab), IL-17 (secukinumab, ixekizumab, brodalumab) and IL-23 (guselkumab, risankizumab, tildrakizumab) inhibitors. The objective of this narrative review is to revise efficacy and safety data of the latest biologicals, small oral molecules and biosimilar drugs for the treatment of chronic plaque psoriasis at Phase III of clinical development. The latest IL-17 and IL-23 inhibitors include bimekizumab, netakimab and mirikizumab as well as oral small molecules, such as deucravacitinib, a tyrosine kinase 2 selective inhibitor, and piclidenoson, an agonist of the Gi protein-associated A3 adenosine receptor. Additional molecules are in an early phase of development. Highly promising biologicals and small oral molecules are the leading edge of the systemic treatment of psoriasis.

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Treat-to-Target Approach for the Management of Patients with Moderate-to-Severe Plaque Psoriasis: Consensus Recommendations

Cited by 39 publications

References 62 publications

Incidence of Skin Cancer in Patients With Chronic Inflammatory Cutaneous Diseases on Targeted Therapies: A Systematic Review and Meta-Analysis of Observational Studies

Incidence of Skin Cancer in Patients With Chronic Inflammatory Cutaneous Diseases on Targeted Therapies: A Systematic Review and Meta-Analysis of Observational Studies

Cumulative Clinical Benefits of Biologics in the Treatment of Patients with Moderate-to-Severe Psoriasis over 1 Year: a Network Meta-Analysis

Latest Advances for the Treatment of Chronic Plaque Psoriasis with Biologics and Oral Small Molecules

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