Infliximab Bests DMARDs in Controlling Radiological Progression in Patients With Early RA: Presented at ACR/ARHP
By Liz Meszaros
PHILADELPHIA -- October 21, 2009 -- Among patients with early rheumatoid arthritis (RA) who do not respond to methotrexate alone, adding infliximab reduces radiological progression better than adding conventional disease-modifying anti-rheumatic drugs (DMARDs). That is the key finding of an updated analysis presented here October 20 at the 2009 Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/AHRP).
In a previous analysis of data from SWEFOT, Ronald F. van Vollenhoven, MD, Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden, and colleagues concluded that in patients with early RA in whom methotrexate treatment failed, addition of a tumour necrosis factor antagonist (infliximab) to methotrexate monotherapy is clinically superior to the addition of conventional DMARDs (Lancet 2009;374:459).
In this present analysis of the SWEFOT data, the researchers specifically assessed radiological progression in these patients.
Patients with early RA (N = 258), defined as symptom duration <1 year, who failed to achieve a DAS-28 of <3.2 after 3 to 4 months of monotherapy with methotrexate were randomised to receive either sulfasalazine 2,000 mg/day plus hydroxychloroquine 400 mg/day (n = 130) or infliximab 3 mg/kg (n = 128). Radiographs were taken in the intent-to-treat group at baseline, 12, and 24 months, and scored in blinded fashion according to the van der Heijde Sharp (vdH-S) method by 2 readers. Per-protocol subjects were analysed separately.
In the intent-to-treat population, both treatment groups exhibited statistically significant radiographical progression from baseline after 12 months. During year 2, significant progression was seen only in the group treated with conventional therapy, and not in the group treated with infliximab.
Mean increases in the total vdH-S total score at 12 months were 5.04 in the conventional treatment group and 2.95 in the infliximab/methotrexate group. At 24 months, these were 7.23 and 4.00, respectively. The difference in progression from baseline to 24 months between the groups was statistically significant for total vdH-S score (P = .009), for erosion score (P = .039), and joint-space narrowing (P = .026). Difference in total vdH-S progression between months 12 and 24 was also significant (P = .011).
According to an analysis of the per-protocol completers, significantly greater progression occurred during year 2 in the conventional treatment group compared with those treated with infliximab/methotrexate (P = .013). In those treated with infliximab/methotrexate who completed the 24-month study, progression during year 2 was minimal compared with patients treated with conventional therapy (.10 vs. 2.77, respectively).
“After initial failure of methotrexate in early RA, addition of anti-TNF is clinically superior to the addition of conventional DMARD therapy, and yields significantly better radiological results through 24 months,” said Dr. van Vollenhoven.
This study received funding from the Swedish Rheumatism Association and Schering-Plough.
[Presentation title: In Early RA With Insufficient Response to MTX, the Addition of Anti-TNF Results in Less Radiological Progression Over 24 Months Than the Addition of Conventional DMARDs: Results from the SWEFOT Trial. Abstract LB6]
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