Aggressive therapy in patients with early arthritis results in similar outcome compared with conventional care: the STREAM randomized trial

Abstract

Objective: To compare the effects of aggressive tight control therapy and conventional care on radiographic progression and disease activity in patients with early mild inflammatory arthritis.

Methods: Patients with two to five swollen joints, Sharp-van der Heijde radiographic score (SHS) <5 and symptom duration ≤2 years were randomized between two strategies. Patients with a definite non-RA diagnosis were excluded. The protocol of the aggressive group aimed for remission (DAS < 1.6), with consecutive treatment steps: MTX, addition of adalimumab and combination therapy. The conventional care group followed a strategy with traditional DMARDs (no prednisone or biologics) without DAS-based guideline. Outcome measures after 2 years were SHS (primary), remission rate and HAQ score (secondary).

Results: Eighty-two patients participated (60% ACPA positive). In the aggressive group (n = 42), 19 patients were treated with adalimumab. In the conventional care group (n = 40), 24 patients started with hydroxychloroquin (HCQ), 2 with sulfasalazine (SSZ) and 14 with MTX. After 2 years, the median SHS increase was 0 [interquartile range (IQR) 0-1.1] and 0.5 (IQR 0-2.5), remission rates were 66 and 49% and HAQ decreased with a mean of -0.09 (0.50) and -0.25 (0.59) in the aggressive and conventional care group, respectively. All comparisons were non-significant.

Conclusion: In patients with early arthritis of two to five joints, both aggressive tight-control therapy including adalimumab and conventional therapy resulted in remission rates around 50%, low radiographic damage and excellent functional status after 2 years. However, full disease control including radiographic arrest in all patients remains an elusive target even in moderately active early arthritis. Trial registration. Dutch Trial Register, http://www.trialregister.nl/, NTR 144.

Fig. 1

Consort flow diagram.

Fig. 2

Cumulative probability plot of radiographic progression. Radiographic progression (Sharp/van der Heijde units) at 2 years compared with baseline in the tight control group (open dots) and conventional care group (closed dots). Every dot represents a patient. The dotted line is set at 5 Sharp/van der Heijde units as the minimal clinically important difference.

Fig. 3

Secondary endpoints for DAS and HAQ in the aggressive group and the conventional care group. Upper: mean DASs at each time point. Middle: remission rates (percentage of patients with DAS < 1.6) at each time point. Bottom: median HAQ scores at baseline, 1 and 2 years. Open dots represent the tight-control group and closed dots represent the conventional care group.