Background Early intensive treatment with infliximab (IFX), high dose IV steroids and treating to target have been shown to be effective for remission induction in pts with early RA.
Objectives To compare MTX+IFX vs. MTX+high dose IV steroid as induction therapy on radiographic progression in pts with DMARD naïve RA.
Methods A 78 wk RCT of pts with early (3-12 months symptoms),DMARD naïve RA (1987 ACR criteria, DAS>2.4). Pts were randomised to 1of 2 grps:IFX or IVsteroid. Treatment was blinded to wk 26 then guided using a treat to target approach. Both grps received MTX 10mg wkly increasing to 20mg by wk 6. The IFX grp received: IFX 3mg/kg (wks 0,2,6,14,22)+dose adjustment from wk 26 according to DAS44. The IVsteroid grp received: IV methylprednisolone (MP) 250mg at wk 0, placebo infusions at wks 2,6,14,22 & from wk 26 treatment escalation as follows if DAS >2.4: add SSZ+HCQ, then stop SSZ+HCQ & add LEF, then 1 of the following: MTXs/c+LEF or MTX+ciclosporin or MTX+LEF+prednisolone 5-7.5mg dly.IM MP 120mg was administered if DAS >2.4 at wks 6,14,22,38,50 & 62 for both grps. Other biologics were allowed from wk 26 per NICE guidelines.
Radiographs of hands & feet done at 0,26,52 & 78 wks were scored using the modified Sharp-van der Heijde (vdH-S) method by 2 independent radiologists blinded to treatment grp;mean of the readers’ scores was taken. Smallest detectable change was calculated to be 2 units.
Results 112 pts were randomised to MTX+IFX (n=55) or MTX+IVsteroid (n=57). Baseline mean (SD) age IFX 53.7 (13.3) vs. IVsteroid grp 53.1 (12.8); mean (SD) DAS28CRP IFX 4.2 (1.1) vs. IVsteroid 3.6 (1.1). Remission (DAS<1.6) at wk 50 was achieved in 51.9% (28/54) in the IFX & 35.7% (20/56) in the IVsteroid grp (p=0.088).
Baseline median (IQR) joint space narrowing (JSN), erosion (ERO) and total vdH-S scores (TS) in the IFX (n=42) and IVsteroid (n=51) grps were: JSN 2.0 (0.0-7.5) and 1.5 (0.0-7.0), ERO 0.0 (0.0-1.6) and 0.5 (0.0-2.5), TS 3.0 (0.0-9.5) and 2.5 (0.5-9.5) respectively. At wk 52 (primary endpt), the median change in total vdH-S score was 0.0 (0.0-1.1) units in the IFX and 0.0 (0.0-2.0) units in the IVsteroid arm (p=0.157); median changes did not differ at 26 wks [IFX=0.0 (0.0-0.6) IVsteroid=0.0 (0.0-1.0), p=0.295] or 78 wks [IFX=0.0 (0.0-2.6) IVsteroid=0.5 (0.0-2.4), p=0.325]. Similar results were seen for JSN and ERO scores. Proportions of pts with radiographic non-progression (vdH-S <2.0) in the IFX and IVsteroid arms were 37/4 (88.1%) vs. 43/5 (84.3%) respectively at 26 wks (Pearson’s chi-sq p=0.601); 36/42 (85.7%) vs. 39/51 (76.5%) at 52 wks (p=0.261); 31/42 (73.8%) vs. 36/51 (70.6%) at 78 wks (p=0.730). No between-grp differences were seen with non-progression defined as change≤0.5: 29/42 (69.0%) in the IFX and 29/51 (56.9%) in the IVsteroid grp (p=0.227) at 52 wks.
Conclusions In this study of DMARD naïve pts with moderate to severe RA, initial therapy with IFX+MTX and high dose IV steroid+MTX, together with tight disease control prevented radiographic progression in a significant majority of patients.
Disclosure of Interest None Declared
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