Guselkumab Treatment Outcomes and Persistence in a Nationwide Real-world Cohort of Patients with Plaque Psoriasis

Mälkönen, Tarja; Nuutinen, Pauliina; Hallinen, Taru; Soini, Erkki; Nissinen, Riikka; Wennerstöm, Christina; Rantanen, Tapio; Hagman, J.; Harvima, Rauno J.; Höök‐Nikanne, Johanna; Ilves, Tiina; Lintu, P.; Malanin, Ken; Soramäki, Iina; Tasanen, Kaisa; Teho, Arja; Vähävihu, Katja; Itälinna, Sari; Leinonen, Pekka; Sarajärvi, Piia; Huilaja, Laura; Pasternack, Rafael

doi:10.2340/actadv.v101.910

Cited by 14 publications

(6 citation statements)

References 14 publications

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“…Eighty-five patients had a follow-up duration of at least 1 year and among them 73 (86%) were still on guselkumab at 1 year. 31 High improvements were seen in the absolute PASI scores with 32 patients having absolute PASI ≤ 2 after a 9–14-month treatment. 31 A prospective, observational, single-center, real-life study on 23 patients conducted by Megna et al demonstrated the efficacy and efficiency of guselkumab, showing that, at week 12, 95.6% of patients achieved PASI 75, while 43.5% PASI 90 whereas PASI 100 was reached by 26%.…”

Section: Methodsmentioning

confidence: 93%

“… 31 High improvements were seen in the absolute PASI scores with 32 patients having absolute PASI ≤ 2 after a 9–14-month treatment. 31 A prospective, observational, single-center, real-life study on 23 patients conducted by Megna et al demonstrated the efficacy and efficiency of guselkumab, showing that, at week 12, 95.6% of patients achieved PASI 75, while 43.5% PASI 90 whereas PASI 100 was reached by 26%. 32 Moreover, at week 44, PASI 75, PASI 90, and PASI 100 were reached by 95.6%, 73.9%, and 43.5% respectively.…”

Section: Methodsmentioning

confidence: 93%

“…Median treatment duration was 11 months; during follow-up 21 patients (12%) discontinued treatment. 31 The most frequently reported reason for discontinuation was primary non-response (9 patients), followed by loss of response, lack of compliance or other causes. Eighty-five patients had a follow-up duration of at least 1 year and among them 73 (86%) were still on guselkumab at 1 year.…”

Section: Methodsmentioning

confidence: 99%

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Guselkumab, Risankizumab, and Tildrakizumab in the Management of Psoriasis: A Review of the Real-World Evidence

Ruggiero¹,

Picone²,

Fabbrocini³

et al. 2022

CCID

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Interleukin (IL)-23 inhibitors, guselkumab, risankizumab, and tildrakizumab, represent the latest class of biologics approved for the treatment of moderate-to-severe psoriasis. Since their approval numerous real-life studies were published on anti-IL-23 use in routine clinical practice. Indeed, real-life data are important to improve the dermatological decision-making process, including patients who are typically excluded from clinical trials, such as subjects suffering from several comorbidities, subjects on polypharmacy, as well as multifailure patients. Herein, we performed a comprehensive literature review about real-life data available on guselkumab, risankizumab, and tildrakizumab. Real-life data of anti-IL-23 seem to confirm the promising results of IL-23 shown by clinical trials, highlighting the efficacy and safety profiles of this new class of biologics also in clinical practice.

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Section: Methodsmentioning

confidence: 93%

Section: Methodsmentioning

confidence: 93%

Section: Methodsmentioning

confidence: 99%

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Guselkumab, Risankizumab, and Tildrakizumab in the Management of Psoriasis: A Review of the Real-World Evidence

Ruggiero¹,

Picone²,

Fabbrocini³

et al. 2022

CCID

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“…(PASI ≤ 3 in 65% and 79% and corresponding PASI ≤ 1 in 34.2% and 50.8% of patients after 3 and 7 months, respectively) [ 18 ], Mälköne et al. (PASI ≤ 2 in 80% of patients after 9–14 months) [ 19 ], and with modified NRI method by Del Alcázar et al. (PASI ≤ 4 in 78.4% and 80.1% and corresponding PASI ≤ 2 in 63.8% and 72.7% of patients after 4 and 6 months, respectively) [ 11 ].…”

Section: Discussionmentioning

confidence: 99%

Long-Term Efficacy, Safety, and Drug Survival of Guselkumab in Patients with Psoriasis: Real-World Data from the Czech Republic BIOREP Registry

Hugo

Kojanová

Turkova

et al. 2023

Dermatol Ther (Heidelb)

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Background Real-world data on the long-term use of guselkumab for treatment of psoriasis are still limited. Objective We aimed to evaluate long-term efficacy, safety, and drug survival of guselkumab in a real-world setting. Methods This is a retrospective study analyzing Czech Republic registry (BIOREP) data of patients treated with guselkumab. Results In total, 333 patients were included. Improvement in Psoriasis Area and Severity Index (PASI) score was significant. Mean PASI score decreased from 16 at baseline to 0.7, 0.9, and 0.8 after 12, 24, and 36 months, respectively. Absolute PASI scores of ≤ 3 and ≤ 1 were achieved in 93.9% and 77.9%, 94.2% and 71.0%, and 94.8% and 70.7% of patients after 12, 24, and 36 months, respectively. Response PASI 90 and PASI 100 were attained in 81.8% and 57.1%, 75.4% and 50.7%, and 75.9% and 55.2% of patients after 12, 24, and 36 months, respectively. The percentage of patients achieving PASI 90 and PASI 100 responses was higher throughout the study in bio-naive and in normal-weight patients, while presence of psoriatic arthritis had no influence. Improvement in Dermatology Life Quality Index (DLQI) score was also significant; mean DLQI score decreased from 14.2 at baseline to 0.9, 1.0, and 0.7 after 12, 24, and 36 months, respectively. Patients with PASI 100 had lower mean DLQI throughout the study compared with patients with PASI 90. Major reason for discontinuation was loss of effectiveness in 7.1% of patients, while only 0.6% were due to adverse events. Overall cumulative drug survival was high, with only a minimal decline over time, reaching 91.6%, 87.0%, and 85.5% after 12, 24, and 36 months, respectively. Drug survival was not affected by previous biological treatment, patient weight, or presence of psoriatic arthritis. Conclusions This real-world study demonstrated the long-term effectiveness, good safety profile, and high drug survival of guselkumab treatment over a period of 36 months.

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“…PASI 90 and PASI 100 responses are considered the treatment goals in moderate-to-severe psoriasis, suggesting complete or nearly complete clearance, generally related to significant improvement in health-related quality of life. As a human monoclonal antibody targeting the p19 subunit of IL-23, guselkumab was the first antibody of its class to be approved for treating moderate-to-severe plaque psoriasis in adults (7)(8)(9)(10). In this study, guselkumab was administered as a 100-mg subcutaneous injection at weeks 0 and 4, and then at 8-week intervals.…”

Section: Discussionmentioning

confidence: 99%

Long-term efficacy and safety of guselkumab in Chinese patients with moderate-to-severe plaque psoriasis

Zheng,

Chen,

et al. 2023

Front. Med.

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BackgroundRandomized controlled trials indicated guselkumab, the first anti-interleukin-23 monoclonal antibody, is efficacious in plaque psoriasis. However, guselkumab's performance in real life is scarcely examined, especially in China.ObjectivesThis work aimed to assess the long-term effectiveness of guselkumab in actual clinical practice in China.MethodsA retrospective study was performed for plaque psoriasis cases administered guselkumab in Shanghai Skin Disease Hospital between January 2020 and September 2022.ResultsA total of 37 patients were included (29 men, 78.4%), with a mean follow-up period of 72.3 ± 26.7 weeks (range of 12–108 weeks). At baseline, clinical examination revealed a mean PASI of 12.3 ± 7.1, a mean BSA of 17.1 ± 18.1, and a mean DLQI of 7.7 ± 4.3. Twenty-two (62.9%) and 17 (48.6%) cases achieved PASI 90 and PASI 100 responses at week 28. From weeks 60 to 92, >80% of cases achieved PASI 90 and PASI 100 responses. Regarding safety, no cases of serious AEs were recorded. A total of nine cases (24.3%) had different abnormal results in HBV markers, and two were T-SPOT positive. There was no hepatitis B virus or tuberculosis outbreak in these patients.ConclusionThis real-life study confirmed the long-term efficacy and safety of guselkumab in daily clinical practice.

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Guselkumab Treatment Outcomes and Persistence in a Nationwide Real-world Cohort of Patients with Plaque Psoriasis

Cited by 14 publications

References 14 publications

Guselkumab, Risankizumab, and Tildrakizumab in the Management of Psoriasis: A Review of the Real-World Evidence

Guselkumab, Risankizumab, and Tildrakizumab in the Management of Psoriasis: A Review of the Real-World Evidence

Long-Term Efficacy, Safety, and Drug Survival of Guselkumab in Patients with Psoriasis: Real-World Data from the Czech Republic BIOREP Registry

Long-term efficacy and safety of guselkumab in Chinese patients with moderate-to-severe plaque psoriasis

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