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Smolen JS, Beaulieu A, Rubbert-Roth A, Ramos-Remus C, Rovensky J, Alecock E, Woodworth T, Alten R; on behalf of OPTION Investigators.

Lancet 2008; 371:987–997.

The OPTION study was a 24-week, double-blind, randomised, Phase III study designed to evaluate the efficacy of tocilizumab (TCZ) in patients with moderate to severe RA who had had an inadequate response to methotrexate (MTX). Patients were randomly assigned to receive TCZ 8 mg/kg (n=205), TCZ 4 mg/kg (n=214) or placebo (PBO) in combination with MTX (n=204).

Key study results are summarised below.

• By Week 24, significantly more patients receiving TCZ achieved ACR20 than those receiving PBO (59% in the 8 mg/kg group; 48% in the 4 mg/kg group; 26% in the PBO group; p<0.0001 for both TCZ groups vs. PBO).
  • More TCZ patients achieved ACR50 (44% in the 8 mg/kg group; 31% in the 4 mg/kg group; 11% in the PBO group; p<0.0001 for both TCZ groups vs. PBO) and ACR70 responses (22% in the 8 mg/kg group; 12% in the 4 mg/kg group; 2% in the PBO group; p<0.0001 for both TCZ groups vs. PBO) than those receiving PBO.

• A meaningful improvement in disease activity was seen as early as Week 2 with TCZ treatment, and DAS28 continued to improve over time in the 8 mg/kg group.
  • DAS28 remission (<2.6) at Week 24 was achieved in significantly more patients in the TCZ groups than in the PBO group.

• Significantly better responses in all core-set variables were seen with TCZ than with PBO – regardless of whether physician (swollen joint count, tender joint count and global assessment of disease activity [visual analogue scale; VAS]), patient (global assessment of disease activity VAS, pain VAS and Health Assessment Questionnaire) or laboratory (C-reactive protein and erythrocyte sedimentation rate) derived.
• TCZ was generally well tolerated. More TCZ patients reported at least one adverse event than PBO patients (69% in the 8 mg/kg group; 71% in the 4 mg/kg group; 63% in the PBO group) but the incidence of serious adverse events (SAEs) was similar between groups (6% in all groups).
  • The most common SAEs were serious infections, reported by six patients in the TCZ 8 mg/kg group, three in the 4 mg/kg group and two in the PBO group.

The authors conclude that the OPTION study provides evidence that inhibition of interleukin-6-mediated proinflammatory effects significantly and rapidly improves the signs and symptoms of RA, with a marked improvement from baseline seen in all ACR core set variables.

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