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Purpose: We previously reported that, in patients with early RA who failed to respond to MTX monotherapy, the addition of anti-TNF was clinically superior at 12 months to the addition of DMARDs (Lancet 374:459;2009). Here, we compared the effects on radiological progression over 2 years of these two therapeutic strategies.
Methods: Patients with early RA (symptom duration <1 year) who failed to achieve DAS28<3.2 after 3-4 months of MTX monotherapy were randomized to the addition of either SSZ 2000 mg/d + HCQ 400 mg/d (arm A, n=130) or infliximab (INF) 3 mg/kg (arm B, n=128). Radiographs taken at baseline, 12 and 24 months were scored according to the Van der Heijde - Sharp (SvdH) method by two readers blinded to treatment assignment. The data were analyzed primarily according to intention-to-treat. No extrapolations or imputations were applied. We also separately analyzed per-protocol (PP) completers. Comparisons were by Wilcoxon rank-test for paired and Mann-Whitney U-test for unpaired values.
Results: In the ITT populations, statistically significant radiographic progression from baseline was seen in both groups after 12 months, whereas during the second year significant progression was seen in group A (conventional therapy) but not in group B (anti-TNF). Mean±SEM (median, IQR) increases in SvdH total scores at 12 and 24 months were 5.04±10.64 (1, 0-7.5) and 7.23±12.72 (3, 0-14.25) for group A, versus 2.95±6.07 (0, 0-5) and 4.00±10.05 (1, 0-6) for group B. The difference in progression from baseline to 24 months between the groups was statistically significant for total SvdH score (p=0.009) as well as for erosion score (p=0.039) and joint-space narrowing (p=0.026) separately. The difference in total SvdH progression between 12 and 24 months was also significant (p=0.011).
In PP completers at 24 months, significantly greater progression occurred during year 2 in group A than in group B (p=0.013). In group B completers, progression during year 2 was minimal at 0.10±3.19 (0, IQR 0-1), versus 2.77±7.76 (0, 0-3) for group A completers.
Conclusions: In patients with early RA who after 3-4 months on MTX had not achieved a DAS28 < 3.2, the addition of INF yielded significantly better radiological results through 24 months than the addition of SSZ+HCQ.
Under the assumption that an initial trial with MTX monotherapy is adequate,
the subsequent addition of anti-TNF is superior concerning radiological
progression to the addition of these conventional DMARDs.
Disclosure: R. F. van Vollenhoven, Abbott, Schering-Plough, UCB Pharma, Wyeth, 2, Abbott, Schering-Plough, UCB, Wyeth, 5 ; K. Albertsson, None; K. Forslind, None; P. Geborek, None; S. Ernestam, None; I. F. Petersson, Anamar Medical, 1 ; J. Bratt, None.