Secukinumab treatment of moderate to severe plaque psoriasis in routine clinical care: real‐life data of prior and concomitant use of psoriasis treatments from the <scp>PROSPECT</scp> study

Körber, Andreas; Thaçi, Diamant; Kiedrowski, Ralph von; Bachhuber, Teresa; Melzer, Nima; Kasparek, Torben; Kraehn-Senftleben, G.; Amon, Ulrich; Augustin, Matthias

doi:10.1111/jdv.14604

Cited by 15 publications

(28 citation statements)

References 18 publications

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“…11 PROSPECT is an ongoing single-cohort, non-interventional study (NIS) conducted in 335 sites across Germany with a study duration of 24 weeks, recruiting subjects for whom the decision of treatment with secukinumab for plaque psoriasis has been made before inclusion. 11 PROSPECT is an ongoing single-cohort, non-interventional study (NIS) conducted in 335 sites across Germany with a study duration of 24 weeks, recruiting subjects for whom the decision of treatment with secukinumab for plaque psoriasis has been made before inclusion.…”

Section: Study Design and Endpointsmentioning

confidence: 99%

“…11 Data were collected by treating physicians and site staff in electronic case report forms (eCRF); entered data were checked automatically for completeness and accuracy. 11 Data were collected by treating physicians and site staff in electronic case report forms (eCRF); entered data were checked automatically for completeness and accuracy.…”

Section: Data Collectionmentioning

confidence: 99%

“…PROSPECT study design and an interim analysis of the baseline characteristics of the first 800 subjects recruited were previously published. 11 PROSPECT is an ongoing single-cohort, non-interventional study (NIS) conducted in 335 sites across Germany with a study duration of 24 weeks, recruiting subjects for whom the decision of treatment with secukinumab for plaque psoriasis has been made before inclusion. Planned recruitment is 2504 subjects.…”

Section: Study Design and Endpointsmentioning

confidence: 99%

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Secukinumab is effective in treatment of moderate‐to‐severe plaque psoriasis: real‐life effectiveness and safety from the PROSPECT study

Thaçi

Körber

Kiedrowski³

et al. 2019

Acad Dermatol Venereol

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Background Secukinumab, a fully human anti‐interleukin‐17A monoclonal antibody, has demonstrated efficacy and safety in patients with moderate‐to‐severe psoriasis. Trial protocols specify transition periods and prohibit concomitant psoriasis medication. Data are therefore needed on secukinumab effectiveness and safety in routine clinical practice. Objectives The PROSPECT study assesses prior and concomitant psoriasis treatments and transition periods in subjects receiving secukinumab. Here, we report interim effectiveness and safety data for secukinumab in the context of prior and concomitant treatments. Methods PROSPECT is an ongoing 24‐week, single‐cohort, non‐interventional study. Subjects with moderate‐to‐severe psoriasis with a decision to receive secukinumab 300 mg were included. Results Of 1988 subjects, 1238/1988 (62.4%) were male, and mean age was 48.1 ± 13.7 years. Mean baseline Psoriasis Area and Severity Index (PASI) score was 17.7 ± 12.5. 90.9% of subjects had prior systemic treatment. Concomitant treatment was recorded in 44.3% of subjects. Median duration of transition period was 14.0, 30.0 and 44.5 days from prior topical, conventional systemic and biologic treatments. At Week 24, PASI75/90/100 was reached by 86.1%, 68.5% and 39.7% of subjects who started secukinumab treatment at baseline. No unexpected safety signals were observed. Conclusion PROSPECT provides a large prospective real‐world analysis of secukinumab treatment and includes prior and concomitant use of psoriasis treatments in subjects receiving secukinumab in a real‐world setting. Secukinumab effectiveness and safety were comparable to that seen in the phase 2/3 secukinumab clinical trial programme.

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Section: Study Design and Endpointsmentioning

confidence: 99%

Section: Data Collectionmentioning

confidence: 99%

Section: Study Design and Endpointsmentioning

confidence: 99%

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Secukinumab is effective in treatment of moderate‐to‐severe plaque psoriasis: real‐life effectiveness and safety from the PROSPECT study

Thaçi

Körber

Kiedrowski³

et al. 2019

Acad Dermatol Venereol

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“…Efficacy was evaluated by comparing the Psoriasis Area and Severity Index (PASI) 75 and PASI 90 response rates at week 8, 12, 16, 32 and 48. Results For patients who received the labelled dose vs. those who did not, PASI 75 response rates were achieved at week 8,12,16,32 and 48 by 60% vs. 40% (P < 0Á01), 72% vs. 61% (P < 0Á01), 77% vs. 75%, 85% vs. 77% and 79% vs. 78%, respectively. PASI 90 responses were achieved at the same time points by 45% vs. 31% (P < 0Á01), 49% vs. 40% (P < 0Á01), 54% vs. 47%, 55% vs. 47% and 57% vs. 54% for those who received the labelled dose vs. those who did not, respectively.…”

mentioning

confidence: 98%

“…3 There is an increasing amount of data on the therapeutic efficacy and safety profile of secukinumab in patients with plaque psoriasis in real-life settings. [5][6][7][8][9] However, clinical studies that investigate the efficacy and safety of secukinumab using a posology other than the labelled dose are lacking. The primary objective of this study was to investigate the efficacy and safety of secukinumab 300 mg administered without the initial weekly loading dose in patients with chronic plaque psoriasis.…”

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confidence: 99%

Efficacy of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis

et al. 2019

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Summary Background Secukinumab is administered at the labelled dose of 300 mg at weeks 0, 1, 2, 3, 4 (loading dose) and every 4 weeks thereafter. Objectives To investigate the efficacy of secukinumab administered without the initial loading dose in patients with psoriasis. Methods This was a retrospective observational study including adult patients with psoriasis (n = 156) treated with secukinumab 300 mg administered either according to the labelled dose (n = 75) or without the initial loading dose (n = 81). Efficacy was evaluated by comparing the Psoriasis Area and Severity Index (PASI) 75 and PASI 90 response rates at week 8, 12, 16, 32 and 48. Results For patients who received the labelled dose vs. those who did not, PASI 75 response rates were achieved at week 8, 12, 16, 32 and 48 by 60% vs. 40% (P < 0·01), 72% vs. 61% (P < 0·01), 77% vs. 75%, 85% vs. 77% and 79% vs. 78%, respectively. PASI 90 responses were achieved at the same time points by 45% vs. 31% (P < 0·01), 49% vs. 40% (P < 0·01), 54% vs. 47%, 55% vs. 47% and 57% vs. 54% for those who received the labelled dose vs. those who did not, respectively. A greater proportion of patients receiving secukinumab without the loading dose discontinued treatment because of inefficacy (25% vs. 13%, P < 0·05), particularly those with body weight greater than 80 kg. Conclusions Secukinumab administered without the loading dose is associated with a higher proportion of primary inefficacy, and achieved inferior results compared with the labelled dose at week 8 and week 12, but showed similar efficacy thereafter. What's already known about this topic? Secukinumab is an interleukin (IL)‐17A inhibitor for chronic plaque psoriasis administered by subcutaneous injections at the labelled dose of 300 mg at weeks 0, 1, 2, 3, 4 (loading dose) and every 4 weeks thereafter (maintenance dose). Dose adjustment is common in clinical practice, and can consist of dose reduction when a prolonged remission is obtained or a dose increase in order to improve efficacy. What does this study add? The efficacy of secukinumab administered without the initial weekly loading dose was significantly inferior compared with the labelled dose in the short term, but was similar after week 16 and up to week 48. A greater proportion of patients receiving secukinumab without the loading dose showed primary inefficacy, particularly those with body weight greater than 80 kg.

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Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in Europe: Baseline Data from SERENA Study

et al. 2020

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Introduction: Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, has demonstrated robust efficacy in the treatment of moderate to severe psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with a rapid onset of action, sustained long-term clinical responses and a consistently favourable safety profile across phase 3 trials. Here, we report the clinical data at enrolment from SERENA, designed to investigate the real-world use of secukinumab across all three indications. Methods: SERENA is an ongoing, longitudinal, observational study conducted at 438 sites across Europe in patients with moderate to severe plaque PsO, active PsA or active AS. Patients should have received at least 16 weeks of secukinumab treatment before enrolment in the study.

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Secukinumab treatment of moderate to severe plaque psoriasis in routine clinical care: real‐life data of prior and concomitant use of psoriasis treatments from the PROSPECT study

Cited by 15 publications

References 18 publications

Secukinumab is effective in treatment of moderate‐to‐severe plaque psoriasis: real‐life effectiveness and safety from the PROSPECT study

Secukinumab is effective in treatment of moderate‐to‐severe plaque psoriasis: real‐life effectiveness and safety from the PROSPECT study

Efficacy of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis

Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in Europe: Baseline Data from SERENA Study

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