Real-world outcomes in patients with moderate-to-severe plaque psoriasis treated with guselkumab for up to 1 year

Galluzzo, Marco; Talamonti, Mark S.; Bernardini, Nicoletta; Chiricozzi, Andrea; Simone, Clara De; Bonifati, C.; Bruni, Pierluigi; Diotallevi, Federico; Esposito, Maria; Graceffa, Dario; Hansel, Katharina; Loconsole, Francesco; Moretta, Gaia; Mugheddu, Cristina; Papini, Manuela; Richetta, Antonio Giovanni; Skroza, Nevena; Atzori, Laura; Fargnoli, Maria Concetta; Persechino, Severino; Offidani, Annamaria; Stingeni, Luca; Peris, Ketty; Potenza, Concetta; Bianchi, Luca

doi:10.1080/14712598.2022.2090835

Cited by 5 publications

(4 citation statements)

References 34 publications

(44 reference statements)

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“…Biologics targeting IL-23 p19 are also a safe long-term treatment option for patients with psoriasis who have a variety of clinical characteristics. Notably, data from real-world studies have extended the safety of guselkumab, tildrakizumab, and risankizumab in a broader population of patients with psoriasis, including older patients, patients for whom multiple previous biologics failed, and those with comorbidities, such as obesity, metabolic syndrome, cardiovascular disease, dyslipidemia, diabetes, hypertension, and PsA [ 38 – 42 , 44 , 69 – 72 , 81 , 82 ]. Based on the available data, safety concerns usually associated with inhibitors of IL-17 signaling [ 88 ] (oral candidiasis, induction or worsening of IBD, and suicidal ideation and behavior) occurred infrequently with IL-23 p19 inhibitors [ 30 , 61 , 77 ].…”

Section: Discussionmentioning

confidence: 99%

“…Guselkumab was well tolerated in patients with a previous failure of ustekinumab and/or IL-17 inhibitor therapy [ 38 , 39 ], in overweight/obese patients [ 40 , 41 ], in heavily pretreated patients (mean of 4 prior biologics) [ 42 ], and in older patients (mean age 71 years) with multiple comorbidities [ 43 ]. Data from one of the larger ( N = 307) real-world studies conducted in Italy reported AEs in only ten patients (3%); all AEs were mild in severity with the exception of one transient ischemic attack, and two patients (1%) discontinued guselkumab due to an AE (erythroderma and general malaise, n = 1 each) [ 44 ].…”

Section: Safety Of Il-23 P19 Inhibitorsmentioning

confidence: 99%

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Safety of IL-23 p19 Inhibitors for the Treatment of Patients With Moderate-to-Severe Plaque Psoriasis: A Narrative Review

et al. 2023

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The approved biologics targeting interleukin (IL)-23 p19 for the treatment of moderate-to-severe plaque psoriasis, including guselkumab, tildrakizumab, and risankizumab, have generally favorable safety profiles. The aim of the current review is to describe in detail the safety of these selective inhibitors. A literature search was performed using PubMed from inception to 1 November 2022, to identify clinical trials and real-world evidence publications using the keywords “guselkumab,” “tildrakizumab,” and “risankizumab.” Overall, the most common adverse events (AEs) associated with IL-23 p19 inhibitors in clinical trials were nasopharyngitis, headache, and upper respiratory tract infections. Rates of serious AEs and AEs of interest, including serious infections, nonmelanoma skin cancer (NMSC), malignancies excluding NMSC, major adverse cardiovascular events, and serious hypersensitivity reactions, were not increased with long-term use in clinical trials. Selectively targeting IL-23 p19 was also not associated with elevated risk of opportunistic infections, tuberculosis reactivation, oral candidiasis, or inflammatory bowel disease. Results from real-world studies were similar, supporting the safe long-term use of these biologics in a wider population of patients with psoriasis, including older patients, patients for whom multiple biologics failed, and those with comorbidities such as obesity, metabolic syndrome, cardiovascular disease, dyslipidemia, diabetes, hypertension, and psoriatic arthritis. This review is limited by the lack of direct comparisons among therapeutic agents due to differences among study designs and safety data reporting methods. In conclusion, the favorable safety profiles of IL-23 p19 inhibitors support their long-term use in the management of patients with moderate-to-severe psoriasis.

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Section: Discussionmentioning

confidence: 99%

Section: Safety Of Il-23 P19 Inhibitorsmentioning

confidence: 99%

Safety of IL-23 p19 Inhibitors for the Treatment of Patients With Moderate-to-Severe Plaque Psoriasis: A Narrative Review

et al. 2023

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“…Given the expectation of patients for longtime maintenance following discontinuation, studies evaluating long-term control upon guselkumab withdrawal are urgently required. In a recent longitudinal, retrospective analysis in the real-world setting with moderate-severe chronic plaque psoriasis, guselkumab showed to maintain its efcacy for up to 12 months [10]. However, studies assessing the maintenance time after guselkumab withdrawal are still scarce.…”

Section: Introductionmentioning

confidence: 99%

A Retrospective Study of Time to Relapse following Guselkumab Withdrawal in Patients with Psoriasis

Zhuang

Zhang

Zhong

et al. 2023

Dermatologic Therapy

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Background. Psoriasis is a chronic immune-mediated skin disease requiring long-term management. However, for various reasons such as financial issues, treatment cessation is common among psoriasis patients who have achieved clinical remission. Currently, only few studies have assessed the time to relapse after guselkumab withdrawal in the real-world setting. Objective. The study aimed at assessing the time to relapse after remission following guselkumab discontinuation in patients with moderate-to-severe plaque psoriasis in the real-world setting. Materials and Methods. Eligible adult moderate-to-severe plaque psoriasis patients received at least 2 doses of administration of guselkumab treatment between March 2020 and March 2022 were enrolled. The study included patients who achieved PASI < 3 at week 12. Relapse was defined as restart of systemic therapy upon guselkumab withdrawal. Time to relapse was defined as the time interval between the last guselkumab administration and restart of systemic therapy. Results. Totally, 76 patients were enrolled. Relapse was found in 60.5% of patients, with a median PASI score at relapse of 4.6 (IQR: 1.6, 8.4) and median time to relapse was 201 (IQR: 159, 314) days. The proportion of patients with comorbidities significantly differed between the relapse and nonrelapse groups at baseline ( P < 0.05 ). Compared with patients with PASI < 3, those with PASI ≥ 3 at relapse had longer time to relapse ( P < 0.001 ). Conclusions. Guselkumab provides durable maintenance of response after discontinuation of therapy in the real-world setting. Higher PASI score at relapse was associated with longer time to relapse. This trial is registered with Chinese Clinical Trial Registry: ChiCTR2000041398.

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“…Instead, current treatment guidelines refer to absolute values, e.g., PASI <3 and the Dermatology Life Quality Index (DLQI) ≤5 [2][3][4][5]. However, although several studies have evaluated the real-world effectiveness of individual IL-17 or IL-23 drugs in psoriasis by PASI and DLQI [6][7][8][9][10][11][12][13][14][15][16][17][18], few have yet assessed the absolute values. The objective of this study was to analyze treatment response and proportions of patients that reach the treatment targets in terms of clinical and HRQoL outcomes in patients using IL-17 and IL-23 inhibitors in clinical practice.…”

Section: Introductionmentioning

confidence: 99%

The Use of IL-17 and IL-23 Inhibitors in Swedish Clinical Practice: A Register-Based Analysis

2022

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Background: Interleukin (IL) inhibitors have made completely cleared skin achievable for many patients with moderate to severe psoriasis in clinical trial settings. Few observational studies assess treatment response in accordance with treatment goals in guidelines. Objectives: The aim of the study was to analyze the treatment response of IL-17/IL-23 inhibitors in clinical practice and the proportions of patients that reach the treatment target of the Psoriasis Area and Severity Index (PASI) < 3 and the Dermatology Life Quality Index (DLQI) ≤5. Methods: A longitudinal, observational study based on the Swedish National Registry for Systemic Treatment of Psoriasis, PsoReg. Patients using IL-17/IL-23 inhibitors with assessments of PASI, DLQI, and EQ-5D before (maximum 6 months) and after (3–12 months) initiation of IL-17/IL-23 were included. Results: In total, 333 patients using IL-17/IL-23 inhibitors were included. Eighty percent (n = 266) received IL-17 inhibitors, and 20% (n = 67) received IL-23 inhibitors. Sixty-six percent of patients reached both PASI <3 and DLQI ≤5, 23% reached one target, and 11% reached none. The mean (SD) PASI, DLQI, and EQ-5D improvements were 6.75 (6.99), 7.14 (7.97), and 0.126 (0.296), respectively. There was no statistically significant difference in outcomes between IL-17 and IL-23 inhibitor treatment groups. Conclusions: IL-17/IL-23 inhibitors are effective in clinical practice, but there is still an unmet therapeutic need in moderate to severe psoriasis.

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Real-world outcomes in patients with moderate-to-severe plaque psoriasis treated with guselkumab for up to 1 year

Cited by 5 publications

References 34 publications

Safety of IL-23 p19 Inhibitors for the Treatment of Patients With Moderate-to-Severe Plaque Psoriasis: A Narrative Review

Safety of IL-23 p19 Inhibitors for the Treatment of Patients With Moderate-to-Severe Plaque Psoriasis: A Narrative Review

A Retrospective Study of Time to Relapse following Guselkumab Withdrawal in Patients with Psoriasis

The Use of IL-17 and IL-23 Inhibitors in Swedish Clinical Practice: A Register-Based Analysis

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