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Secukinumab Efficacy Without the Initial Loading Dose in Patients With Psoriasis

Secukinumab Efficacy Without the Initial Loading Dose at Weeks 0, 1, 2, 3 and 4 in Patients With Chronic Plaque Psoriasis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03828643
Enrollment
156
Registered
2019-02-04
Start date
2019-03-20
Completion date
2019-04-12
Last updated
2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis Vulgaris

Keywords

Secukinumab, loading dose, chronic plaque psoriasis, no loading dose

Brief summary

This was a retrospective, observational study. The objective of the study is investigate the efficacy and safety of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis. Patients were stratified in two groups, those receiving secukinumab at the dose 300 mg every 4 weeks from the beginning (cases) and those who received the initial label, weekly loading dose (controls). Efficacy was evaluated by comparing the proportion of patients achieving PASI75 responses at week 16, 32 and 48 between cases and controls. Safety was evaluated by reporting every adverse events up to week 48.

Interventions

DRUGSecukinumab

Secukinumab 300 mg without loading dose at weeks 0, 1, 2, 3 and 4.

Sponsors

Universita di Verona
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients older than 18 years old * Patients with moderate to severe chronic plaque psoriasis treated with secukinumab with or without initial loading dose for at least 48 week * The criteria for receiving secukinumab were according to standard clinical practice.

Exclusion criteria

* Patients younger than 18 years old * Patients with only psoriatic arthritis or with other forms of psoriasis than chronic plaque type (such as drug-induced psoriasis or guttate, erythrodermic, or pustular psoriasis) * Pregnant women and women during breastfeeding

Design outcomes

Primary

MeasureTime frame
PASI75week 48

Secondary

MeasureTime frame
PASI90week 48

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026