Tocilizumab Tops Methotrexate Monotherapy in RA Patient-Reported Outcomes: Presented at EULAR

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Tocilizumab Tops Methotrexate Monotherapy in Rheumatoid Arthritis

Patient-Reported Outcomes:

Presented at EULAR

By Jill Stein

http://www.docguide.com/news/content.nsf/news/852571020057CCF68525746A00776AF7

PARIS -- June 16, 2008 -- Tocilizumab monotherapy appears to result in

better patient-reported outcomes compared with methotrexate monotherapy,

among patients with active rheumatoid arthritis (RA) who responded to

previous methotrexate or biologic treatment.

These findings, from the 24-week, phase 3 Actemra Versus Methotrexate

Double-Blind Investigative Trial in Monotherapy (AMBITION) trial were

presented here on June 13 at EULAR 2008, the Annual Congress of the European

Union League Against Rheumatism.

Sebba, MD, Arthritis Research of Florida Inc., Palm Harbor, Florida,

and coworkers compared the effects of monotherapy with tocilizumab and

methotrexate on health and physical functioning at 24 weeks of treatment in

572 patients with moderate to severe active RA.

Tocilizumab is a humanised anti-interleukin (IL)-6 receptor (IL-6R)

monoclonal antibody that binds to both membrane-expressed and soluble IL-6R,

disrupting signalling by IL-6 and the IL-6/IL-6R complex.

Subjects were randomised to either tocilizumab 8 mg/kg every 4 weeks or to

an escalating methotrexate dose of 7.5 to 20 mg weekly.

Baseline demographic and clinical characteristics were similar between

treatment groups.

The results showed that tocilizumab was superior to methotrexate, with a

higher proportion of patients achieving American College of Rheumatology

20%, 50%, and 70% responses and Disease Activity Score 28 remission at week

24, Dr. Sebba said.

At 24 weeks, larger mean changes in Health Assessment

Questionnaire-Disability Index scores were seen in the tocilizumab group

than in the methotrexate group (-0.73 vs -0.55). This was higher than the

minimal clinically important difference (MCID) of -0.22.

Improvements were seen in both groups at week 24 in the Short Form-36 health

survey (SF-36) physical component (PCS) and mental component (MCS) scores.

However, a larger improvement occurred in the tocilizumab group (PCS, 10.0

vs 8.4; MCS, 7.2 vs 5.5; MCID, 2.5-5.0).

An improvement in SF-36 score was apparent as early as week 8, and

tocilizumab-treated patients had larger mean improvements than methotrexate

in the individual domain scores of the SF-36.

Importantly, greater mean increases in Functional Assessment of Chronic

Illness Therapy-Fatigue (FACIT-Fatigue) score were observed for patients in

the tocilizumab arm compared with the methotrexate arm (9.2 vs 6.5; MCID,

4.0) at week 24, with improvements in the tocilizumab arm seen as early as

week 4.

" Fatigue is a substantial problem for rheumatoid arthritis patients and the

improvements observed with tocilizumab on the FACIT-Fatigue score are likely

to be of considerable clinical benefit in patients overall, " the authors

wrote in their poster presentation.

They concluded that the improvements in all patient-reported outcomes seen

with tocilizumab were consistently greater than with methotrexate

monotherapy.

Funding for the study was provided by Roche.

[Presentation title: Tocilizumab Monotherapy Improves Quality of Life

Compared With Methotrexate Monotherapy in Patients With Rheumatoid

Arthritis: The Ambition Study. Abstract FRI0174]