Treatment of patients with plaque psoriasis with secukinumab in a real-life setting: a 52-week, multicenter, retrospective study in Spain

Notario, J.; Deza, Gustavo; Vilarrasa, Eva; Valentí, F; Muñoz, Carlos; Mollet, Jordi; Rocamora, Vicenç; Carrascosa, José Manuel; Alcázar, E. del; Alsina, M.; Vidal, David; Puig, Lluís; López‐Ferrer, Anna; Riera, José Ramón Martínez; Gallardo, Fernando; Ferrán, Marta

doi:10.1080/09546634.2018.1528000

Cited by 65 publications

(99 citation statements)

References 15 publications

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“…Nevertheless, BMI was also associated with poorer treatment response in both real-life and trial settings. 2,5 In our experience, drug survival of secukinumab is not as low as initially reported. These findings are likely affected by the high rate of patients naive to biologic therapy (47.6%) and by the dropout rate (17% at 12 months and 20% at 18 months) in line or slightly lower than some recent real-life studies.…”

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confidence: 49%

Secukinumab drug survival in patients with psoriasis: A multicenter, real-world, retrospective study

Torres

Balato

Conrad

et al. 2019

Journal of the American Academy of Dermatology

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To the Editor: Secukinumab, an interleukin 17A inhibitor approved for the treatment of moderate-tosevere plaque psoriasis, has shown high levels of clinical efficacy and a favorable safety profile in both short-term and long-term clinical trials. However, in some studies in the real-life setting, secukinumab showed a 73%-78% drug survival at 12 months, shorter than that of other biologic agents, even among biologic-naive patients, and loss of effectiveness was the most common reason for discontinuation. 1-4 To evaluate drug survival of secukinumab in a daily practice setting, we retrospectively evaluated all psoriatic patients starting secukinumab during January 2016-February 2017 at 11 centers in 3 European countries and followed them until February 2018 (potentially with at least 1 year of observation period). Failure was defined as stopping secukinumab definitively or switching to a different therapy. Drug survival was analyzed using KaplaneMeier methodology. A total of 330 patients were included. Their median 6 standard deviation age was 51.9 6 14.6 years, 68% were male, and 19.6% were obese (body mass index [BMI] $30 kg/m 2); 21.5% of patients had a diagnosis of psoriatic arthritis, and 52.4% were biologic-experienced (24.5% with $2 prior biologics). All patients were treated with the 300-mg label dose, and there was no dose adjustment throughout the treatment. Concomitant systemic therapy was used in 12% of patients (mostly methotrexate). Overall drug survival of secukinumab was 83% after 12 months and 78.8% after 18 months (Fig 1, A). The dropout rate at 18 months was 20%: 12.4% of patients were lost to follow-up, 6.7% of patients stopped because of drug ineffectiveness, 0.3% of patients discontinued because of adverse events, and 0.6% of patients decided to quit the drug. Drug survival rates at 12 and 18 months were lower for biologic-experienced than biologic-naive patients (Fig 1, B) and lower in obese than nonobese patients. Patients treated with concomitant systemic therapies also showed a lower drug survival rate than those treated with secukinumab monotherapy at 12 months (79.5% vs 94.2%, respectively) and 18 months (53.7% vs 81.8%, respectively). Univariate Cox regression analysis of drug survival determinants showed that prior use of [1

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confidence: 49%

Secukinumab drug survival in patients with psoriasis: A multicenter, real-world, retrospective study

Torres

Balato

Conrad

et al. 2019

Journal of the American Academy of Dermatology

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“…69.2 versus 48.8%, and PASI100: 51.3 versus 41.5%. Similarly, another retrospective study in Spain confirmed the better clinical response in biologic-naïve and nonobese patients (Notario et al, 2019). This rapid and higher clinical improvement was also observed in our cohort, where 61.9 versus 42.9%, 76.2 versus 69.6%, and 85.7 versus 83.9% of the treatment-naïve versus experienced patients reached ΔPASI75, (Ger, Huang, Hui, Tsai, & Chiu, 2019), the number of prior biologic failures also seemed to impact the treatment response to secukinumab, with biologic-naïve patients having a better response rate in this study as well.…”

Section: Drug Survivalmentioning

confidence: 60%

“…IL‐17 inhibitor secukinumab has been shown to achieve a rapid and significant clinical response in patients with moderate‐to‐severe skin psoriasis with or without coexisting PsA, with a tendency to better response in biologic treatment‐naïve patients (Blauvelt et al, ; Galluzzo et al, ; Notario et al, ; Schwensen et al, ). A better response to treatment was also observed in the subgroup of our patients who were systemic and biologic treatment‐naïve.…”

Section: Discussionmentioning

confidence: 99%

Real world data from the use of secukinumab in the treatment of moderate‐to‐severe psoriasis, including scalp and palmoplantar psoriasis: A 104‐week clinical study

Rompoti

Katsimbri

Kokkalis

et al. 2019

Dermatologic Therapy

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Several clinical studies demonstrated the safety and efficacy of the interleukin‐17 inhibitor secukinumab in the systemic treatment of moderate‐to‐severe psoriasis, as well as psoriatic arthritis (PsA) in adults, whereas real‐world data is limited. A single‐center clinical study was performed to evaluate in real‐world practice the efficacy of secukinumab up to Week 104 of treatment in moderate‐to‐severe chronic plaque psoriasis, including scalp and palmoplantar involvement, according to Physician Global Assessment (PGA), PASI75/90/100 and scalp, and palmoplantar PGA. Drug survival, the safety profile of secukinumab, and patient's quality of life were also assessed during a 2‐year observation period. Out of 83 patients included, 56.3% were biologic‐naïve, and 94% had scalp, 25.3% palmoplantar, and 43.9% joint involvement. At Week 16, PASI75/PASI90/PASI100 were observed in 83.8/70.0/46.3%, respectively. Scalp and palmoplantar PGA were rapidly improved, with 98.7 and 95.5%, respectively, reaching clear/almost clear skin at Week 16. After 104 weeks, drug survival was 74.5%. A significant improvement of the quality of life was observed. Biologic‐naïve patients without coexisting PsA benefited the most. Real‐world data demonstrated secukinumab efficacious in chronic plaque psoriasis, including specific locations such as scalp and palmoplantar psoriasis with a safety profile similar to that in clinical trials.

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“…In adalimumab‐ and infliximab‐treated patients with psoriasis, antidrug antibodies have been associated with lower drug concentrations and a decreased treatment response . Furthermore, patients with psoriasis who previously received biologicals or who have a high body mass index (BMI) are more likely to have a worse clinical outcome . However, which factors exactly influence the drug concentration and clinical response in ustekinumab‐treated patients with psoriasis remain underexplored.…”

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confidence: 99%

Clinical response correlates with 4‐week postinjection ustekinumab concentrations in patients with moderate‐to‐severe psoriasis

et al. 2019

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Summary Background Cost‐effective use of biologicals is important. As drug concentrations have been linked to clinical outcomes, monitoring drug concentrations is a valuable tool to guide clinical decision‐making. A concentration–response relationship for ustekinumab at trough is uncertain owing to the contradictory results reported. Objectives To investigate the relationship between 4‐week postinjection ustekinumab concentrations and clinical response in patients with psoriasis. Methods Forty‐nine patients with moderate‐to‐severe psoriasis treated with 45 mg or 90 mg ustekinumab every 12 weeks for ≥ 16 weeks were included. Ustekinumab serum concentrations and anti‐ustekinumab antibodies were measured at week 4 after injection and disease severity was assessed by Psoriasis Area and Severity Index (PASI). Results At week 4 after injection, a significantly negative correlation was observed between ustekinumab concentrations and absolute PASI score up to 5·9 μg mL−1 (ρ = –0·357, P = 0·032). Ustekinumab concentrations were higher in optimal responders (PASI ≤ 2) than in suboptimal responders (PASI > 2) (4·0 vs 2·8 μg mL−1, P = 0·036). The ustekinumab concentration threshold associated with optimal response was determined to be 3·6 μg mL−1 (area under the curve 0·71, sensitivity 86%, specificity 63%). Only one patient (2%) had anti‐ustekinumab antibodies. Psoriatic arthritis was identified as an independent predictor of higher PASI scores and higher ustekinumab concentrations (P = 0·003 and P = 0·048, respectively). Conclusions A concentration–response relationship at week 4 after injection was observed for patients with psoriasis treated with ustekinumab. Monitoring 4‐week postinjection ustekinumab concentrations could timely identify underexposed patients who might benefit from treatment optimization. What's already known about this topic? Monitoring drug concentrations is a valuable tool that can guide clinical decision‐making when drug concentrations are linked to clinical outcomes. The presence of a concentration–response relationship for ustekinumab at trough is still debated owing to the contradictory results reported. What does this study add? A concentration–response relationship at week 4 after injection for ustekinumab‐treated patients with psoriasis was demonstrated. Monitoring 4‐week postinjection ustekinumab concentrations could timely identify underexposed patients who might benefit from treatment optimization. Based on the findings of this study, a treatment algorithm for patients with a suboptimal response is proposed.

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Treatment of patients with plaque psoriasis with secukinumab in a real-life setting: a 52-week, multicenter, retrospective study in Spain

Cited by 65 publications

References 15 publications

Secukinumab drug survival in patients with psoriasis: A multicenter, real-world, retrospective study

Secukinumab drug survival in patients with psoriasis: A multicenter, real-world, retrospective study

Real world data from the use of secukinumab in the treatment of moderate‐to‐severe psoriasis, including scalp and palmoplantar psoriasis: A 104‐week clinical study

Clinical response correlates with 4‐week postinjection ustekinumab concentrations in patients with moderate‐to‐severe psoriasis

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