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Retention and effectiveness of secukinumab in psoriasis patients in real world setting: A multi-center cohort study in Japan

Retention and effectiveness of secukinumab in psoriasis patients in real world setting

125

The age (mean) was 54.9 +- 13.9 years, 67.5% were male, BMI (mean, n = 54) was 24.55 +- 4.56 kg/m2, the duration of psoriasis was 12.26 +- 11.3 years, and 25.5% had psoriatic arthritis. PASI (mean, n = 59) at the start of secukinumab was 9.21 +- 7.37, and 52.8% of patients had used biologics for psoriasis before the start of secukinumab.

A total of 125 subjects were enrolled. 123 subjects excluding 2 subjects who participated in CAIN457AJP01 study (A prospective study to evaluate direct switch from cyclosporine A to secukinumab; NCT02547714) were included in the analysis.

In this study, adverse events information were collected when the reason for secukinumab discontinuation was adverse events. Of the 79 patients who discontinued secukinumab during the observation period, 10.1% (8/79) discontinued due to adverse events. Of the 8 adverse events in 8 patients, 4 events were related to secukinumab, 3 events were not related to secukinumab, and the relationship with secukinumab was unknown in 1 event.

Secukinumab retention rate at Week 52 was 78.0%

Secukinumab retention rates at Week 16 and Week 24 and at Year 2, 3, 4 and 5 were 95.1%, 89.4%, 63.2%, 47.2%, 40.2% and 33.9%, respectively (Kaplan-Meier method,). The most common reason for discontinuation during the entire observation period was inadequate response (70.9%) followed by adverse events (10.1%). As factors affecting the rate of continuation of secukinumab, a history of use of biologics (HR 1.72, p = 0.018) and the presence or absence of concomitant use of topical drugs at the start of secukinumab (HR 2.77, p = 0.018) were inferred (univariate Cox regression analysis). PASI (+- SD) at baseline, Week 52, 2, 3, 4 and 5 were 1.4 (2.6), 1.83 (2.66), 0.99 (1.71), 1.11 (1.5), and 1.31 (1.46), respectively (as observed).

Real-world secukinumab drug retention and efficacy were investigated. Secukinumab retention at Week 52 was 78.0%. The 5-year drug retention was 33.9% and the most common reason for discontinuation was inadequate response.History of biologics use and concomitant use of topical drugs (vitamin D3 monotherapy and/or combination drugs) at the start of secukinumab were inferred as factors affecting long-term secukinumab retention.

No

Novartis Pharma K.K.

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Novartis Pharma K.K.

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+81-120-003-293

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completed

Feb. 01, 2020

Observational

multicenter, retrospective, non-interventional study

treatment purpose

N/A

1.Patients who provide informed consent (written or oral) for study participation
2.Age >=20 at study participation
3.Patients with a documented diagnosis of psoriasis vulgaris with or without PsA and were/are treated with secukinumab according to the Japanese package insert of secukinumab
4.Psoriasis with or without PsA patients who started secukinumab at the participating dermatology institutions after 26-Dec-2014 and whose first day of secukinumab treatment is >52 weeks before the IC collection date

1.Patients whose follow-up visit to the participating institution is <2 after secukinumab initiation

Both

psoriasis vulgaris

investigational material(s)
Generic name etc : Secukinumab(Genetical Recombination)
INN of investigational material : -
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. For some patients, a dose of 150 mg may be acceptable

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

other
The primary endpoint is the time to discontinuation of secukinumab in psoriasis with or without PsA patients followed at medical institutions participating in this study. The estimate of retention rate (the proportion of patients who do not discontinue secukinumab) at Week 52 will be derived.

other
Secukinumab retention rate at other time points
other
Factors associated with secukinumab retention rate
efficacy
Secukinumab effectiveness
other
factors associated with secukinumab effectiveness

+81-6-4393-8403

Dec. 19, 2019