Most RA Patients Qualifying for Therapy w/TNF Blocking Agents May Respond to Escalation of Conventional Therapy

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Majority of Rheumatoid Arthritis Patients Qualifying for Therapy With

Tumour Necrosis Factor Alpha Blocking Agents May Respond to Escalation

of Conventional Therapy

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A DGReview of : " The impact of escalating conventional therapy in

rheumatoid arthritis patients referred for anti-tumour necrosis

factor-{alpha} therapy "

Rheumatology (Oxford) 2003 Dec 1;[Epub ahead of print].

More than half of patients with rheumatoid arthritis (RA) who satisfied

guidelines for treatment with tumour necrosis factor-alpha (TNF alpha)

blocking agents responded satisfactorily to escalated conventional

therapy for at least 1 year, according to a British study.

TNF alpha blocking agents, such as etanercept and infliximab, are highly

effective in reducing RA disease activity. However, due to drug expense

and uncertainties regarding long-term toxicity, biologics are reserved

for patients with persistent active disease failing to respond to

conventional therapy with disease-modifying anti-rheumatic drugs (DMARDs).

Recently, the British Society for Rheumatology (BSR) published

guidelines for appropriate selection of patients for anti-TNF alpha

therapy, which have been adopted by The National Institute of Clinical

Excellence (NICE).

To assess if RA patients qualify for anti-TNF alpha therapy according to

BSR/NICE guidelines, S. J. Bingham of Leeds General Infirmary, Leeds,

United Kingdom, and colleagues conducted a prospective study in 308

consecutive patients considered to have failed conventional therapy.

Prior to starting treatment with biologics, patients were treated

according to a protocol of intensified conventional therapy escalating

from sulphasalazine or methotrexate monotherapy to a combination of

methotrexate and/or sulphasalazine and/or hydroxychloroquine, to

parenteral methotrexate, and finally to leflunomide.

Patient assessment occurred at 12-weekly intervals for 1 year, after

which therapy was altered in cases of unsatisfactory response. For

analysis, the BSR/NICE biologic eligibility criteria were applied

retrospectively, and response to escalated therapy in patients who did

or did not satisfy BSR/NICE criteria were compared.

Results revealed that 159 patients satisfied BSR/NICE criteria and would

have been eligible for immediate treatment with biologics. However, 93

of these patients showed significant improvement in disease activity,

disability, and quality of life as a result of escalated conventional

therapy and did not require biologics.

A moderate or good response (as defined by European League Against

Rheumatism criteria) was achieved with escalated conventional therapy in

32% of patients at 6 months and 55% of patients at 12 months. However,

only 7% of patients achieved a mild disease activity score (DAS28<3.2)

at 12 months.

" The simplistic interpretation of this result is that not all patients

fulfilling BSR/NICE guidelines require anti-TNF alpha therapy, " the

researchers conclude. " The aim of the guidelines is to restrict

biologics to those patients who have no alternatives, but this study

suggests that patients should be required to have failed escalated

therapy in order to qualify. "