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Conventional combination treatment versus biological treatment in methotrexate-refractory early rheumatoid arthritis: 2 year follow-up of the randomised, non-blinded, parallel-group Swefot trial
The Lancet - Early Online Publication, 04/13/2012
van Vollenhoven RF et al. – Additional biological treatment is a valid option for patients who fail initial methotrexate treatment. However, improved clinical outcomes after 12 months and better radiographical results after 24 months should be weighed against the absence of a convincing clinical difference at 24 months and substantially higher costs. Therefore, for many patients who fail initial methotrexate treatment, add–on treatment with disease–modifying antirheumatic drugs is an appropriate treatment option.
Methods- In this randomised, non–blinded, parallel–group trial, the authors enrolled adult patients older than 18 years with rheumatoid arthritis and a symptom duration of less than 1 year from 15 rheumatology units in Sweden between December, 2002 and December, 2006.
- All patients were started on methotrexate.
- After 3–4 months, those who failed treatment were randomly assigned (1:1) to group A (conventional treatment; additional sulfasalazine and hydroxychloroquine) or group B (biological treatment; additional infliximab).
- Randomisation was done with a computer–generated sequence.
- They analysed clinical outcomes at months 18 and 24 by the response criteria of the American College of Rheumatology and the European League Against Rheumatism, and radiographs of patients' hands and feet at months 12 and 24 using the Van der Heijde modification of the Sharp score.
- Analysis was by intention to treat.
- Of 493 screened individuals, they enrolled 487, of whom 258 were randomly allocated to treatment.
- The proportion of patients in group B who received a EULAR–defined good response was non–significantly greater than it was in group A at 18 months (49 of 128 [38%] vs 38 of 130 [29%]) and at 24 months (49 of 128 [38%] vs 40 of 130 [31%]; p=0.204).
- After 24 months, radiological disease progression was greater in patients in group A than it was in those in group B (mean 7.23 [SD 12.72] vs 4.00 [10.0]; p=0.009).
- They recorded three serious adverse events: an extended generalised illness in group A, an extended febrile episode in group B, and a generalised illness in group B.