Study on MTX and REMICADE combo

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Title: DG DISPATCH - EULAR: Remicade Shows Efficacy And Safety Benefits

In Active RA

URL: http://www.pslgroup.com/dg/1060AA.htm

Doctor's Guide

June 9, 1999

By Jack

Special to DG News

GLASGOW, SCOTLAND -- June 9, 1999 -- Researchers presented the results

of a clinical trial with Centocor's

Remicade™ (infliximab) in the treatment of active rheumatoid arthritis

today at the European League Against Rheumatism

(EULAR) congress in Glasgow.

R.N. Maini, director of the Kennedy Institute of Rheumatology, London,

England, made the first public announcement of the

54-week results from the phase III double-blind, placebo-controlled,

randomised trial called " Anti-TNF Trial in Rheumatoid

Arthritis with Concomitant Therapy " (known as ATTRACT).

The 30-week results were presented last year at the American College of

Rheumatology meeting in San Diego.

TNF (tissue necrosis factor)-alpha is an important inflammatory cytokine

and Remicade acts at a molecular level by binding to,

and neutralising, TNF-alpha on the cell membrane and blood. The ATTRACT

study is being carried out at 34 sites in North

America and Europe and is designed to evaluate the safety and efficacy

of Remicade in combination with methotrexate in

patients with active rheumatoid arthritis who have not responded to

methotrexate monotherapy.

In the study, 428 patients were randomly assigned to five Remicade

treatment groups: 3 mg/kg every eight weeks, three mg/kg

every four weeks, 10 mg/kg every eight weeks and 10 mg/kg every four

weeks, and placebo. All patients are maintained on

methotrexate throughout the study.

Outcome measures were ACR-20, which represents a 20 percent reduction in

the number of tender and swollen joints, as well

as physician and patient global assessments and laboratory markers of

inflammation and pain such as C-reactive protein. Two

other, more stringent, key assessments to establish efficacy of

treatment were ACR-50 and ACR-70, which represent 50

percent and 70 percent reductions in the same benchmarks.

At one year, 52 percent of patients treated with Remicade exhibited

significant reductions in signs and symptoms of RA as

reflected in the ACR-20 compared to 17 percent of patients on

methotretaxe monotherapy.

Maini said that 33 percent of patients treated with Remicade achieved an

ACR-50 response compared with nine percent of the

placebo group. In addition, 18 percent of patients in the Remicade group

achieved an ACR-70 response compared with three

percent of the placebo group.

Swollen joints were reduced by 64 percent from baseline with Remicade

compared with 18 percent for the placebo group.

Tender joints were reduced by 69 percent in the Remicade group compared

with 28 percent in the placebo group.

" The rapid and marked improvement in signs and symptoms of RA after

treatment with infliximab is impressive because patients

have now been controlled for one year, " Dr. Maini said.

Even the lowest tested dose, 3 mg/kg every eight weeks, led to improved

function, relief of joint tenderness and reduced joint

swelling in a significant number of patients.

Safety of Remicade

Professor f Smolen, from the department of medicine, Rheumatic

Disease Center, University of Vienna, Austria, presented

the safety findings on Remicade in his presentation at EULAR.

After one year, Remicade is generally well tolerated with very few side

effects. The most common side effects include upper

respiratory tract infection, headache, nausea, sinusitis, rash and

cough, Dr. Smolen explained. However, there was no

difference in the incidence of serious adverse events between the

Remicade group and the placebo group (17 percent versus

21 percent) or in serious infections (six percent versus eight percent).

There were no serious infusion reactions in any of the

groups.

Researchers are still analysing the results of the study to determine

the rates of human antichimeric antibodies (HACA) in the

two treatment groups, Dr. Smolen said. However, he added, only one

patient was found to be HACA positive out of the 32

patients who discontinued treatment.

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