Secukinumab Efficacy Without the Initial Loading Dose in Patients With Psoriasis

NCT03828643 | Completed FDA Drug

• 1 other identifier: Gisondi 3
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis Vulgaris

Keywords

Secukinumab; loading dose; chronic plaque psoriasis; no loading dose

Outcome Measures

Primary Outcomes (1)

• PASI75

  week 48

Secondary Outcomes (1)

• PASI90

  week 48

Study Arms (2)

Cases

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

Drug: Secukinumab

Controls

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

Drug: Secukinumab

Interventions

Secukinumab DRUG

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

Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with moderate to severe chronic plaque psoriasis attended two Dermatological centers of North Italy in Veneto (Azienda Ospedaliera Universitaria of Verona and Azienda Ospedaliera of Padua) dedicated to the care of patients with psoriasis

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

University of Verona

Verona, 37126, Italy

Location

MeSH Terms

Interventions

secukinumab

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 4, 2019
• Study Start: March 20, 2019
• Primary Completion: April 12, 2019
• Study Completion: April 12, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

IT (1)