New drugs for rheumatoid arthritis (RA) are usually tested in clinical trials where patients are recently diagnosed and have not been treated with medications other than the standard therapy. Whether patients with long-standing disease or who have failed to respond to a range of treatments will benefit is often unknown. Lack of evidence of a drug’s efficacy in this situation, coupled with the expense in the case of some new agents, can make doctors unwilling to try them. This is especially the case if patients have not responded well to other disease-modifying treatments in the past.

Now a new study presented at the 2010 American College of Rheumatology meeting in Atlanta, USA, has shown that people with RA are just as likely to respond well to one effective therapy (Cimzia) whether or not they have had their disease for many years or a few weeks and irrespective of the number or type of drugs they have tried before.

The phase IIIb REALISTIC trial included 1063 patients with active RA who may or may not have had RA for several years and who could have been treated with a variety of drugs including up to two biologic treatments that target TNF alpha, and methotrexate or other disease-modifying drugs. Patients were randomized in a 12-week double-blind, phase to either Cimzia (certolizumab pegol) or placebo in addition to their usual treatment before entering a 16-week open-label extension. Many of these patients would have been excluded from the pivotal trials used to determine whether a drug is sufficiently safe and efficacious to be given a marketing licence.

The usual way to assess an arthritis drug’s effectiveness is to measure the percentage reduction in pain, swelling and tenderness in several joints. ACR20 looks for a 20 per cent reduction in symptoms, while ACR50 looks for a 50 per cent improvement and ACR70, a 70 per cent improvement By the end of 12 weeks, twice the percentage of Cimzia-allocated patients in REALISTIC achieved the primary outcome measure of ACR20 as the control group (51.1% vs 25.9%). Patients receiving Cimzia experienced a rapid clinical response, had superior ACR50/70 responses and superior results on other outcomes (DAS28 disease activity score and Health Assessment Questionnaire-Disability Index measuring physical function). Responses were very significantly superior on the ACR20 measure from week 2 (31.8% vs 8.5% p

Written by: Olwen Glynn Owen