Background/Purpose: Patient-reported outcomes (PROs) are important measures when determining response to therapy in patients with RA. Previous RCTs have shown that TCZ monotherapy is superior to both MTX alone and ADA monotherapy for improving RA disease activity.^1,2 These post hoc analyses compared the efficacy of TCZ monotherapy with MTX or ADA monotherapy for improvement of PROs in 2 RCT populations, providing change in Clinical Disease Activity Index (CDAI) as a reference.

Methods: AMBITION and ADACTA were independent RCTs evaluating the efficacy and safety of TCZ compared with MTX or ADA, respectively, in patients with active RA. In AMBITION, patients who were MTX-naive or had discontinued MTX ≥ 6 months prior to baseline without previous inadequate responses to MTX or tumor necrosis factor inhibitors received TCZ 8 mg/kg IV every 4 weeks or MTX. In ADACTA, biologic-naive patients intolerant to or inappropriate for MTX received TCZ 8 mg/kg IV every 4 weeks or ADA 40 mg SC every 2 weeks. PROs, assessed at 24 weeks, included patient global assessment (PtGA; visual analog score [VAS], 0-100 mm), pain (VAS), Health Assessment Questionnaire Disability Index (HAQ-DI, 0-3), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (0-52) and Short Form (SF)-36 (0-100). The proportions of patients reporting PRO scores ≥ minimum clinically important differences (MCID) as well as ≥ age/sex-matched normative values were assessed for each treatment group.

Results: In both RCTs, patients receiving TCZ reported greater improvements across all PROs at week 24 compared with MTX or ADA. In AMBITION, 45.0-84.0% of patients who received TCZ reported scores ≥ MCID in PtGA, pain, HAQ, FACIT, SF-36 PCS/MCS and all domains at week 24 compared with 39.4-81.8% with MTX (Table 1); 24.3-52.1% who received TCZ reported scores ≥ normative values in HAQ (< 0.5), FACIT (≤ 40), SF-36 PCS/MCS (≥ 50) and all domains compared with 14.5-45.0% with MTX (Table 2). In ADACTA, 57.7-83.3% of patients who received TCZ reported scores ≥ MCID in PtGA, pain, HAQ, FACIT, SF-36 PCS/MCS and all domains at week 24 compared with 50.8-75.6% with ADA (Table 1); 22.1-49.3% who received TCZ reported scores ≥ normative values in HAQ, FACIT, SF-36 PCS/MCS and all domains compared with 13.6-37.8% with ADA (Table 2).

Conclusion: Consistent with the CDAI responses from these RCTs, TCZ monotherapy resulted in more patients achieving MCID and normative values, indicative of clinically meaningful improvements, in PROs compared with either MTX or ADA monotherapy in AMBITION and ADACTA. References:

1.    Jones G, et al. Ann Rheum Dis. 2010;69:88-96.

2.    Gabay C, et al. Lancet. 2013;381:1541-1550.