ORBIT Study Shows Rituximab is Non-Inferior to TNF Inhibitors in Biologic Naive Patients Save

Porter and colleagues have reported that both rituximab (RTX) and tumour necrosis factor inhibitors (TNFi)  are equally and highly effective in early, active, biologic-naive rheumatoid arthritis patients.

Current convention has dictated that if a biologic is to be used (e.g., after failing methotrexate), TNFi are the preferred or recommended first biologic.  This study was done to challenge this practice and examine if RTX would be clinically non-inferior and cheaper to TNF inhibitor treatment in rheumatoid arthritis.

This 12 month trial was an open-label, randomised active-controlled, non-inferiority trial of 295 active RA patients, enrolled over a 4 year period to receive standard doses of either RTX or adalimumab (the TNFi) according to the patient's and rheumatologist's choice. Patients could switch treatment in the case of drug-related toxic effects or absence or loss of response.

The 12 month change in DAS28-ESR score was rituximab was -2·6 (SD 1·4) for RTX and -2·4 (SD 1·5) in the TNFi groups. Proving the primary outcome by being within the prespecified non-inferiority margin of -0·19 (95% CI -0·51 to 0·13; p=0·24).

The health-related costs significantly favored the RTX (vs. TNFi) group with a 12 month cost of £9405 vs £11 523 per patient (p<0·0001), respectively.

Serious adverse events were higher in the RTX grouop (n=37) compared patients receiving TNFi (n=26), but these differences were not significant. 

These findings affirm the heterogeneity of RA and what drives it.  Precision or personalized approaches are needed to optimize the outcomes of the first biologic used.  Such and advance would save lives, cost, time and minimize toxicity in those with early active RA.