Patients who have recently developed rheumatoid arthritis respond better to treatment with biological medicine in combination with conventional pharmacological medicine. This according to results of the Swefot national clinical study, which is to be presented at an international rheumatology congress in Paris by scientists from Swedish Karolinska Institutet and Karolinska University Hospital, who conducted the study in association with another 15 rheumatology units in Sweden.
Some 60,000 people in Sweden have rheumatoid arthritis, and another 1,500 develop the disease every year. The symptoms are swollen, tender joints and impaired mobility. Some patients respond poorly to medical treatment and/or develop side effects. The Swefot study, which was launched in 2002, shows that a certain combination of pharmacological medicines and new biological medicines is more efficacious on these patients.
"After the disease has been confirmed in a patient, we start by treating it with Methotrexate, MTX," says Ronald van Vollenhoven, Associate Professor and Senior Physician, and member of the study's steering committee. "But for the group of patients who don't respond well to MTX, it's more effective to add a biological medicine than to combine MTX with an older drug."
Biological medicines are a new group of drugs that have been in use for ten years and that are produced using modern DNA-based methods. What makes them special is that they can be designed to target a specific goal, which makes them more efficacious and reduces the risk of adverse reaction. They can only be injected and are complicated to produce, which means that the cost of a drug for one patient can exceed 100,000 kronor a year.
"Biological medicines have revolutionised rheumatologic therapy, but there are still some concerns, as the long-term effects are not fully known, and these medications are very expensive", says Dr van Vollenhoven. "The Swefot trial is the first study in which the addition of biological treatment is compared directly to the addition of conventional antirheumatic medications."
The study involved 487 patients, who had developed rheumatoid arthritis in the previous year. First they were treated with the most established anti-rheumatic medicine Methotrexate (MTX); after three or four months, the 258 patients who did not respond well to MTX were divided randomly into two treatment groups. Group A received a combination treatment with MTX, Sulfasalazin, and Plaquenil, three proven anti-rheumatic drugs. Group B received treatment with MTX and anti-TNF or Remicade (Infliximab), one of the most widely used biological drugs.
The analysis showed after twelve months that 26 per cent of the patients in Group A and 42 per cent of the patients in Group B responded well to the therapy. The difference was highly statistically significant and has been corroborated by several other analyses that also suggest the better efficacy of treatment strategy B. For the patients, a good response to the medicines means less pain and stiffness, better general wellbeing, improved function and a better quality of life.
Reference: The results of the study are to be presented on 12 June 2008 at an international rheumatism congress in Paris organised by the European League Against Rheumatism (EULAR). See the abstract for details of participating hospitals and scientists.