Efficacy, Safety & Tolerability of Infliximab in Juvenile-onset Spondyloarthropathies (JO-SpA)

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Presentation Number:749

Presentation Time:11/8/2007 4:30:00 PM

Title:Efficacy, Safety, and Tolerability of Infliximab in Juvenile-onset

Spondyloarthropathies (JO-SpA): Results of the Three-Month, Randomized,

Double-Blind, Placebo-Controlled Trial Phase

Category:28. Spondylarthropathies and psoriatic arthritis: clinical aspects

and treatment

Author(s): Burgos-Vargas, Julio Casasola-Vargas, Raúl Gutierrez-Suarez,

Janitzia Vazquez-Mellado. Hospital General de Mexico, Mexico city, Mexico

JO-SpA, including enthesitis related arthritis, is characterized by

peripheral arthritis and enthesitis, impaired functioning, and in some cases

structural changes on the long-term. Infliximab -a TNF-α blocking monoclonal

antibody- is effective and safe in the treatment of SpA. Case series in

children with JO-SpA showed the same results.

Objectives. To demonstrate superior clinical efficacy with infliximab

administered at a dose 5mg/kg compared with placebo, in controlling the

signs and symptoms of active juvenile onset SpA over a period of 12 weeks.

Material and Methods. Patients with JO-SpA patients (ESSG classification

criteria; onset <16 years; screening <18 years) with active arthritis ≥2

joints; enthesitis ≥3 peripheral sites; VAS pain ≥ 40 mm; and no response to

NSAID and sulfasalazine or methotrexate. Main exclusion criteria: Pregnancy;

lack of contraceptive methods; functional class IV; psoriasis, inflammatory

bowel disease; infectious diseases, mainly TB; prednisone ≥10 mg/day. This

is a two-phase investigator initiative study, 1st phase: 12-week,

randomized, double-blind, placebo-controlled; 2nd phase 52 week extension.

Diagnostic stratification: undifferentiated SpA or ankylosing spondylitis

(AS). Primary efficacy measure: number of active joints. Secondary and

exploratory efficacy measures were also included. Patients received either

infliximab 5mg/kg or placebo at weeks 0, 2, and 6.

Results. We included 26 patients (25 males, median age at onset 15.2 years

[9-18]; 21 with u-SpA and 5 with AS). Twelve patients received infliximab

and 14 placebo. All patients completed the double-blind phase of the trial.

We found no significant differences between the groups at baseline regarding

demographic and clinical features, particularly those included in the

primary, secondary and exploratory analysis.

In the infliximab group, the number of active joints decreased from a median

of 5 (2-10) to 0.8 (0-7) at week 12; change in the placebo group was not

significant, from 6 (3-16) to 4.2 (0-11).

The difference between infliximab and placebo groups was significant. Most

secondary and exploratory efficacy measures favored infliximab over placebo

at significant levels. Likewise, there were no significant differences in

the frequency of adverse events; no serious adverse events were recorded.

Conclusion. Infliximab significantly the inflammatory signs and symptoms of

JO-SpA. Infliximab efficacy is significantly superior to the effect of

placebo, but the frequency of adverse events is similar.

Disclosures:R. Burgos-Vargas, Schering Plough, 2 Research grants; Abbott, 5

Consulting fees; Roche, 5 Consulting fees; Schering Plough, 5 Consulting

fees; Wyeth, 5 Consulting fees; Novartis, 5 Consulting fees; Pfizer, 5

Consulting fees.