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      Use of Guselkumab for the Treatment of Moderate-to-Severe Plaque Psoriasis: A 1 Year Real-Life Study

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          Abstract

          Little information is available from real-life studies evaluating the efficacy of guselkumab in moderate-to-severe psoriasis. In this real-life study, we retrospectively examined a database of 52 patients with moderate-to-severe psoriasis treated with guselkumab (100 mg, s.c.) and followed for 1 year. Disease severity and treatment response was assessed by the Psoriasis Area and Severity Index (PASI) at baseline and after 4, 12, 20, 28, 36, 44, and 52 weeks. Predictors of a PASI response were evaluated by univariate and multivariate regression. After 12 months, 84.2% of patients (mean age 51.3 ± 14.1 years) treated with guselkumab achieved a PASI score of <3. Furthermore, PASI score decreased from 20 ± 13.3 at baseline to 4.4 ± 4.7 and 2.7 ± 3.9 at 12 and 20 weeks, and PASI 75, 90, and 100 response was achieved in 84.2%, 78.9%, and 63.2% of patients respectively at 12 months. Stepwise multivariate regression analysis revealed that previous biological treatment and the presence of comorbidities were associated with poorer response between 28–44 weeks, however the presence of obesity per se was not associated with poorer response. Difficult-to-treat areas were also improved as early as 12 weeks following guselkumab. Guselkumab was observed to be effective and safe in patients with moderate-severe chronic psoriasis in a real world-setting.

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          Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2).

          Ustekinumab, a human monoclonal antibody against interleukins 12 and 23, has shown therapeutic potential for psoriasis. This study assessed the efficacy and safety of ustekinumab in psoriasis patients and assessed dosing intensification in partial responders. In this multicentre, phase III, double-blind, placebo-controlled study, 1230 patients with moderate-to-severe psoriasis (defined by a psoriasis area and severity index [PASI] score > or =12, and at least 10% total body surface area involvement) were randomly assigned to receive ustekinumab 45 mg (n=409) or 90 mg (n=411) at weeks 0 and 4, then every 12 weeks, or placebo (n=410). Partial responders (ie, patients achieving > or =50% but <75% improvement from baseline in PASI) were re-randomised at week 28 to continue dosing every 12 weeks or escalate to dosing every 8 weeks. Both randomisations were done with a minimisation method via a centralised interactive voice response. The primary endpoint was the proportion of patients achieving at least 75% improvement in PASI (PASI 75) at week 12. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00307437. All randomised patients were included in the efficacy analysis. 273 (66.7%) patients receiving ustekinumab 45 mg, 311 (75.7%) receiving ustekinumab 90 mg, and 15 (3.7%) receiving placebo achieved the primary endpoint (difference in response rate 63.1%, 95% CI 58.2-68.0, p<0.0001 for the 45 mg group vs placebo and 72.0%, 67.5-76.5, p<0.0001 for the 90 mg group vs placebo). More partial responders at week 28 who received ustekinumab 90 mg every 8 weeks achieved PASI 75 at week 52 than did those who continued to receive the same dose every 12 weeks (22 [68.8%] vs 11 [33.3%]; difference in response rate 35.4%, 95% CI 12.7-58.1, p=0.004). There was no such response to changes in dosing intensity in partial responders treated with ustekinumab 45 mg. During the placebo-controlled phase, 217 (53.1%) patients in the 45 mg group, 197 (47.9%) in the 90 mg group, and 204 (49.8%) in the placebo group experienced adverse events; serious adverse events were seen in eight (2.0%) patients in the 45 mg group, five (1.2%) in the 90 mg group, and eight (2.0%) in the placebo group. Although treatment with ustekinumab every 12 weeks is effective for most patients with moderate-to-severe psoriasis, intensification of dosing to once every 8 weeks with ustekinumab 90 mg might be necessary to elicit a full response in patients who only partially respond to the initial regimen.
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            Cigarette smoking, body mass index, and stressful life events as risk factors for psoriasis: results from an Italian case-control study.

            We conducted a case-control study to analyse the association of psoriasis of recent onset with smoking habits, body mass index (BMI) and stressful life events. Cases (n=560; median age 38) were patients with a first diagnosis of psoriasis and a history of skin manifestations of no longer than two years after the reported disease onset. Patients with a new diagnosis of skin diseases other than psoriasis (n=690; median age 36) were selected as controls. The risk of psoriasis was higher in ex- and current smokers than in never-smokers, the relative risk estimates (OR) being 1.9 for ex-smokers and 1.7 for smokers. Smoking was strongly associated with pustular lesions (32 patients, OR=5.3 for smokers). The frequency of psoriasis varied significantly in relation to a family history of psoriasis in first degree relatives, BMI (OR=1.6 and 1.9 for over weighted, BMI 26-29, and obese, BMI >/= 30, respectively) and stressful life event score (compared to the lower index quartile, the OR being 2.2 for index values >/=115). Risk estimates, when taking into consideration the combined effect of these factors with smoking habits, were consistent with a multiplicative model of risk combination with no significant statistical interaction.
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              Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial

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                Author and article information

                Journal
                J Clin Med
                J Clin Med
                jcm
                Journal of Clinical Medicine
                MDPI
                2077-0383
                09 July 2020
                July 2020
                : 9
                : 7
                : 2170
                Affiliations
                [1 ]Dermatology Unit, Fondazione Policlinico, “Tor Vergata”, 00133 Rome, Italy; marco.galluzzo83@ 123456gmail.com (M.G.); lorenzotofani@ 123456hotmail.it (L.T.); lombardopaolo89@ 123456gmail.com (P.L.); alessandra.petruzzellis@ 123456gmail.com (A.P.); dionisio.silvaggio@ 123456gmail.com (D.S.); luca.bianchi@ 123456uniroma2.it (L.B.)
                [2 ]Department of Experimental Medicine, University of Rome “Tor Vergata”, 00133 Rome, Italy
                [3 ]CE Medical Writing, 56023 Pisa, Italy; colingegan@ 123456gmail.com
                [4 ]Department of Systems Medicine, University of Rome “Tor Vergata”, 00133 Rome, Italy
                Author notes
                [* ]Correspondence: talamonti.marina@ 123456gmail.com ; Tel.: +39-0620902743
                [†]

                These authors contributed equally to this work.

                Author information
                https://orcid.org/0000-0002-3424-5175
                https://orcid.org/0000-0003-1286-9507
                https://orcid.org/0000-0003-0866-914X
                https://orcid.org/0000-0002-6942-7147
                https://orcid.org/0000-0001-8697-6896
                https://orcid.org/0000-0002-3070-4071
                Article
                jcm-09-02170
                10.3390/jcm9072170
                7408922
                32659978
                22267631-54ff-464a-b910-4c5c95e245ca
                © 2020 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 12 June 2020
                : 07 July 2020
                Categories
                Article

                psoriasis,biological drugs,guselkumab,psoriasis area and severity index (pasi),real-life

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