Guselkumab in moderate to severe psoriasis in routine clinical care: an Italian 44-week real-life experience

Megna, Matteo; Fabbrocini, Gabriella; Cinelli, Eleonora; Camela, Elisa; Ruggiero, Angelo

doi:10.1080/09546634.2020.1800577

Cited by 42 publications

(65 citation statements)

References 17 publications

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“…Few series of real clinical practice that reflect the use of guselkumab have been published so far. 4 These data are slightly better than those presented in our series. indicating a high survival rate if the treatment at mid-term.…”

Section: Discussioncontrasting

confidence: 56%

Guselkumab: Mid‐term effectiveness, drug survival, and safety in real clinical practice

Ruiz‐Villaverde

Rodriguez‐Fernandez‐Freire

Armario‐Hita

et al. 2021

Dermatologic Therapy

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Guselkumab is a fully human immunoglobulin-G1-lambda (IgG1λ) monoclonal antibody that binds selectively to the p19 subunit of interleukin 23. Few series of real clinical practice that reflect the use of guselkumab have been published so far, including the measure of survival at more than 52 weeks. An observational, longitudinal, retrospective study of real clinical practice of patients with moderate to severe psoriasis receiving treatment with guselkumab 100 mg subcutaneous every 8 weeks in five tertiary hospitals in Andalusia (Spain) was carried out. A total of 87 patients were included in this study. Disease severity and treatment response was assessed by PASI, BSA, VAS pruritus, and DLQI at baseline and after 4, 12, 24, 36, 52, and 76 weeks. Data are presented as mean ± SD for continuous variables, and number and percentage for categorical variables. To determine the differences between visits in PASI, BSA, VAS pruritus, and DLQI a Wilcoxon matched-pairs test was performed. The survival of guselkumab was calculated using Kaplan-Meier survival analysis. Our population presented with a mean age of 49.9 years, 60.9% of them were male, had a mean PSO evolution of 20.4 (9.5) years. A total of 79.3% were obese or presented with overweight and had several comorbidities (dyslipidemia 28.7%, arterial hypertension 23% and 20% diabetes among others). At baseline their disease parameters were: PASI = 14.6 (7.2), BSA = 22.3 (16.6), VAS pruritus = 6.0 (2), and DLQI = 15.8 (5). After 52 weeks their disease improved to PASI = 0.9 (1.1), BSA = 1.0 (1.8), VAS pruritus = 0.47 (0.88), and DLQI = 1.54 (2.50). The percentage of patients who achieved PASI 75, 90, and 100 at 52 weeks was 90.3%, 71%, and 51.6%, respectively. The patients evaluated at week 76 (n = 3) reached PASI 0, BSA 0, and DLQI 0. After 93.4 weeks (1 year, 9 months, and 14 days), the overall survival rate was 94% (4 events were reported). A total of four patients discontinue to AE or lack of efficacy after 76 weeks. Guselkumab showed excellent results in the control of psoriasis in the mid-term with an elevated number of patients maintaining treatment after 52 to 76 weeks and a good safety profile.

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Section: Discussioncontrasting

confidence: 56%

Guselkumab: Mid‐term effectiveness, drug survival, and safety in real clinical practice

Ruiz‐Villaverde

Rodriguez‐Fernandez‐Freire

Armario‐Hita

et al. 2021

Dermatologic Therapy

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“…No cases of serious AEs, injection site reaction, candida, malignancy, and cardiovascular events were reported in our experience. In recently published real-life studies, the rate of reported AEs during guselkumab treatment varied from 0% to 30.4%, 7,14,[16][17][18][19][20] including with variable percentages: arthromyalgia, asthenia, infections (upper respiratory infection, tooth infection, and pharyngitis), headache, syncope, and anxiety. 14,[16][17][18][19][20] Furthermore, reported discontinuation rates ranged from 0% to 9.8%, with the most frequent causes of treatment interruption represented by loss of efficacy, outbreak of PsA, arthromyalgia, injection site reaction, panic attack, eczema, and heart palpitation.…”

Section: Discussionmentioning

confidence: 99%

“…To date, only few data have been reported about guselkumab treatment in real-life settings, showing comparable results with trial outcomes. 7 However, more studies, especially focusing on patients who already failed other biologics, are needed to confirm its efficacy and safety. In particular, it is necessary to evaluate guselkumab efficacy in patients who previously failed anti-IL-12/23 (ustekinumab) treatment, due to their partial similar targets, and/or IL-17 inhibitors, due to the role played by IL-23 in the upregulation of IL-17 in the IL23/IL17 axis which drives psoriasis pathogenesis.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of guselkumab in psoriasis patients who failed ustekinumab and/or anti‐ interleukin ‐17 treatment: A real‐life 52‐week retrospective study

Ruggiero

Fabbrocini

Cinelli

et al. 2020

Dermatologic Therapy

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Recent major research advancements have significantly expanded our understanding of psoriasis pathophysiology, resulting in the development of highly effective, targeted therapies. Guselkumab is the first interleukin (IL)‐23 inhibitor approved for the treatment of moderate‐to‐severe‐psoriasis, providing a new therapeutical option for psoriasis. The aim of our study was to evaluate the efficacy of guselkumab in psoriatic patients who previously failed anti‐IL‐12/23 and/or anti‐IL‐17 treatment. A 52‐week single‐center retrospective study was performed enrolling moderate‐to‐severe patients attending our Psoriasis Care Center from October 2018 to May 2020. Study population included 13 patients; 46.1% have been previously treated with ustekinumab, while 69.2% have previously failed an anti‐IL‐17 treatment (38.5% secukinumab, 30.8% ixekizumab, and 38.5% both). At baseline, mean Psoriasis Area and Severity Index was 13.2 ± 6.8, reducing up to 0.5 ± 0.7 at week 52 (P < .001). Body surface area reduced from 22.3 ± 10.5 (baseline) to 0.8 ± 1.1 at week 52 (P < .001). No statistically significant differences have been found between patients previously treated with anti‐IL‐12/23 compared to anti‐IL‐17 or both. Only one patient discontinued guselkumab at week 36 due to secondary inefficacy. This is a single institution study with a relatively small sample size. Our real‐life data confirm trial results, showing guselkumab as a safe and effective option in patients with moderate‐to‐severe psoriasis even in those who previously failed ustekinumab and/or anti‐IL‐17 treatment.

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“…The chronic inflammation that sustains psoriasis has been related to higher levels of pro-inflammatory cytokines [ 18 , 19 , 20 ]. Indeed, it has been shown that the central role is played by the activation of the tumor necrosis factor (TNF)-α pathway as well as increased inflammasome activity and interleukin (IL)-17 and IL-23 [ 18 , 19 , 20 , 21 ]. It is now well-established that patients with severe psoriasis have an excess of systemic inflammation, with a related higher mortality if compared to the general population [ 22 ].…”

Section: Discussionmentioning

confidence: 99%

“…It is believed that psoriasis is not merely a skin disease but other organs like eyes can be affected by a chronic systemic inflammation. However, to date only few studies have evaluated ocular manifestations in psoriasis [ 7 , 8 , 9 , 13 , 19 ]. Eye involvement in psoriasis may be underestimated by dermatologists, although psoriasis has been acknowledged as a systemic disease for decades.…”

Section: Discussionmentioning

confidence: 99%

Ocular Manifestations in Psoriasis Screening (OcMaPS) Questionnaire: A Useful Tool to Reveal Misdiagnosed Ocular Involvement in Psoriasis

Ruggiero

Fabbrocini

Cacciapuoti

et al. 2021

JCM

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Psoriasis is an immune-mediated, chronic inflammatory disease, which mainly affects the skin, although it has systemic pathological effects. Comorbidities of psoriasis include ocular disorders, which are often nonspecific or mildly symptomatic. The aim of this study was to show the importance of ocular-disease screening in psoriatic patients using the Ocular Manifestations in Psoriasis Screening (OcMaPS) questionnaire. Patients suffering from moderate-to-severe psoriasis referring at our outpatient-clinic were consecutively enrolled. Each patient was asked to complete a screening questionnaire (OcMaPS). Patients reporting ocular symptoms were referred for an ophthalmological examination. A total of 372 patients were enrolled in the study. Ocular symptoms were detected in 39 patients (10.5%), and 37 patients were referred to ophthalmological examination which confirmed the presence of ocular manifestation in 30 patients. There were three cases (10%) of uveitis, 14 (46.6%) of dry eye and 13 (43.3%) of cataract, in progress or already treated with surgery. In the remaining seven patients, no ocular manifestations were found. Ocular manifestations in psoriatic patients are not rare. It is important to be aware of ocular symptoms in psoriatic patients, screening patients (with a consultation or OcMaPS questionnaire), which leads to earlier diagnosis and treatment.

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Guselkumab in moderate to severe psoriasis in routine clinical care: an Italian 44-week real-life experience

Cited by 42 publications

References 17 publications

Guselkumab: Mid‐term effectiveness, drug survival, and safety in real clinical practice

Guselkumab: Mid‐term effectiveness, drug survival, and safety in real clinical practice

Efficacy and safety of guselkumab in psoriasis patients who failed ustekinumab and/or anti‐ interleukin ‐17 treatment: A real‐life 52‐week retrospective study

Ocular Manifestations in Psoriasis Screening (OcMaPS) Questionnaire: A Useful Tool to Reveal Misdiagnosed Ocular Involvement in Psoriasis

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