High-dose etanercept in ankylosing spondylitis: results of a 12-week randomized, double blind, controlled multicentre study (LOADET study).

Abstract

OBJECTIVES:

Etanercept 50 mg a week is approved in the treatment of AS. Increasing the etanercept dose to 100 mg/week improves efficacy in cutaneous psoriasis, a clinical manifestation related to the spondylarthritis family, while maintaining its safety profile. The purpose of this study was to evaluate the efficacy and safety of etanercept 100 vs 50 mg/week in patients with AS.

METHODS:

Adult patients with AS were randomized to receive etanercept 50 mg twice a week (biw), or etanercept 50 mg once a week (qw) for 12 weeks. The primary efficacy endpoint was Ankylosing Spondylitis Assessment Study (ASAS20) response at Week 12; secondary endpoints included ASAS40, ASAS50, ASAS70 and ASAS5/6 responses, partial remission and quality of life. Safety was assessed until 15 days after the last visit.

RESULTS:

A total of 108 patients were randomly selected and treated, 54 in each arm. At 12 weeks, ASAS20 response was achieved by 34 (71%) out of 48 patients of the etanercept 50 mg biw group and by 37 (76%) out of 49 patients of the etanercept 50 mg qw group (not statistically significant differences). Other efficacy variables improved significantly over time, but not between treatment groups. Fifty-six patients experienced at least one adverse event (generally, infections and infestations, gastrointestinal disorders and injection site reactions), most of them mild or moderate.

CONCLUSIONS:

High-dose (100 mg/week) etanercept in the treatment of AS for 12 weeks is as safe as the standard dose (50 mg/week). However, it does not significantly increase its efficacy. Trial Registration. Clinicaltrials.gov, http://clinicaltrials.gov/, NCT00873730.

• Authors: Federico Navarro-Sarabia, José L Fernández-Sueiro, Juan C Torre-Alonso, Jordi Gratacos, Rubén Queiro, Carlos Gonzalez, Eduardo Loza, Luis Linares, Pedro Zarco, Xavier Juanola, José Román-Ivorra, Emilio Martín-Mola, Raimon Sanmartí, Juan Mulero, Gema Diaz, Yolanda Armendáriz, Eduardo Collantes
• Journal: Rheumatology (Oxford, England) (Rheumatology (Oxford)) Vol. 50 Issue 10 Pg. 1828-37 (Oct 2011) ISSN: 1462-0332 [Electronic] England
• PMID: 21700683 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Immunoglobulin G
• Immunosuppressive Agents
• Receptors, Tumor Necrosis Factor
• Tumor Necrosis Factor-alpha
• Etanercept

Topics

• Adult
• Dose-Response Relationship, Drug
• Double-Blind Method
• Etanercept
• Female
• Health Status
• Humans
• Immunoglobulin G (therapeutic use)
• Immunosuppressive Agents (therapeutic use)
• Male
• Quality of Life
• Receptors, Tumor Necrosis Factor (therapeutic use)
• Remission Induction
• Severity of Illness Index
• Spondylitis, Ankylosing (drug therapy, physiopathology)
• Treatment Outcome
• Tumor Necrosis Factor-alpha (antagonists & inhibitors)