RA patient’s perspective must be respected in treatment decisions, says study

Physician-reported measures on responses to tofacitinib and adalimumab treatments are higher than those reported by patients with rheumatoid arthritis (RA), according to a post hoc analysis of data from phase III and phase IIIb/IV trials.

“[T]he higher weighting of physician-reported vs patient-reported components to overall response and remission highlights the importance of considering the patient’s perspective when making treatment decisions,” the researchers said.

In this study, data were pooled from phase III trials assessing tofacitinib 5 or 10 mg twice daily, adalimumab, or placebo, with conventional synthetic disease-modifying antirheumatic drugs, and a phase IIIb/IV trial assessing tofacitinib 5 mg twice daily monotherapy, tofacitinib with methotrexate, or adalimumab with methotrexate.

Study outcomes were the proportions of patients achieving American College of Rheumatology (ACR) 20/50/70 responses and ≥20/50/70-percent improvement rates in ACR components at week 2 and months 1, 3, and 6; and the mean percent improvement in ACR components and Clinical or Simplified Disease Activity Index (CDAI or SDAI) low disease activity or remission rates, at month 3, for ACR20/50/70 responders.

Most physician-reported components showed numerically higher ≥20/50/70-percent improvement rates than those reported by patients across treatment groups. [J Rheumatol 2022;49:566-576]

In phase III trials, ≥50/70-percent improvements in patient global assessment of disease activity, pain, and physician global assessment were comparable at earlier timepoints. Among ACR20 responders treated with tofacitinib, mean percent improvements for tender and swollen joint counts were >70 percent at month 3.

Additionally, 27.8–45.0 percent of ACR70 responders receiving tofacitinib achieved CDAI/SDAI remission at month 3.

In the placebo-controlled cohort, ACR20/50/70 response rates and ≥20/50/70-percent improvement rates in ACR components at month 3 were higher with active treatment than with placebo. This finding was consistent with that in previous studies. [Ann Intern Med 2013;159:253-261; Arthritis Rheum 2013;65:559-570; N Engl J Med 2012;367:508-519]

“These improvements were observed from the earliest timepoint for tofacitinib-treated and adalimumab-treated patients (week 2 and month 1, respectively) vs placebo-treated patients,” the researchers said.

“These findings provide insight into the impact that tofacitinib or adalimumab have on the ACR components at month 3, a key timepoint for treatment target assessments, according to the treat-to-target approach for RA,” they noted. [Ann Rheum Dis 2016;75:3-15]

The current study had several limitations, including its post hoc nature, the lack of formal statistical testing, and the small sample size for ACR70 responders. Comparisons between active treatments were also limited in the placebo-controlled cohort.

In addition, the advancement of nonresponder patients to tofacitinib at month 3 could have influenced responses in the tofacitinib groups at month 6. Finally, the clinical trial setting restricted the interpretation of data in a real-world context.

“Many RA clinical trials use ACR response criteria, generally ACR20/50, as the primary outcome measure, whereas only the individual ACR components are commonly assessed in clinical practice,” the researchers said. [Arthritis Rheumatol 2014;66:2339-2343; Arthritis Rheum 2008;59:1371-1377]

“Therefore, to guide clinical decision making, it is important for physicians to have a comprehensive understanding of the effect of RA treatments on the composite measures and individual components,” they added.