Secukinumab Efficacy Without the Initial Loading Dose in Patients With Psoriasis

University of Verona

Status: Completed

Conditions: Psoriasis Vulgaris

Treatments: Drug: Secukinumab

Study type: Observational

Funder types: Other

Identifiers

NCT03828643

Gisondi 3

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

156 participants in 2 patient groups

Cases

Description:

Cases received secukinumab at the dose 300 mg every 4 weeks from the beginning.

Treatment:

Drug: Secukinumab

Drug: Secukinumab

Controls

Description:

Controls received secukinumab at the dose 300 mg with loading dose at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.

Treatment:

Drug: Secukinumab

Drug: Secukinumab