Tampa, FL—Post-hoc analyses of the phase 3 trials, ORAL Standard and ORAL Step, revealed that tofacitinib––a novel oral Janus kinase inhibitor––and adalimumab led to lower monthly medical expenditures (MMEs) compared with placebo in patients with moderate-to-severe rheumatoid arthritis (RA) who did not respond to either methotrexate or tumor necrosis factor (TNF) inhibitors, according to investigators Regina Rendas-Baum, MS, scientist at QualityMetric, and colleagues.
The Oral Standard Trial
The ORAL Standard was a 12-month trial that compared the safety and efficacy of tofacitinib 5 mg or 10 mg twice daily, adalimumab 40 mg every 2 weeks, or placebo in patients receiving methotrexate but not responding to treatment. The ORAL Step, a 6-month trial, compared the safety and efficacy of tofacitinib 5 mg or 10 mg twice daily with placebo in patients receiving methotrexate with inadequate response to TNF inhibitors.
In these post-hoc analyses––performed for the first 3 months of treatment in each trial––the investigators used the 12-Item Short-Form Health Survey (SF-12) v2 to translate physical component summary (PCS) scores and mental component summary (MCS) scores into predicted medical expenditures and assess whether treatment with tofacitinib or adalimumab reduced MME compared with placebo.
“We wanted to translate treatment-related effects captured in the SF-36 [36-Item Short-Form Health Survey] v2 into outcomes that are easily understood and relevant to payers, clinicians, employers and also to patients themselves,” Ms Rendas-Baum told Value-Based Care in Rheumatology. “It is sometimes hard to interpret treatment-related changes captured by patient-reported-outcome measures, such as the SF-36v2, and this type of analysis provides important information about what those treatment-related changes may actually mean beyond their numerical value.” Because of the high correlation between SF-36v2 and SF-12v2, the algorithm based on SF-12v2 was applied to the PCS and MCS scores that were obtained using the SF-36v2, according to Ms Rendas-Baum.
Long-Term Benefits
In the nonresponders included in the ORAL Standard trial, results showed that by the third month, there was a 25%, 23%, and 24% reduction in MME with tofacitinib 5 mg, tofacitinib 10 mg, and adalimumab, respectively, compared with a 13% reduction in MME with placebo.
Substantial reductions in MME were also observed with tofacitinib in the ORAL Step trial for patients with inadequate response to TNF inhibitors. Significant reduction in MME with tofacitinib was evident by 2 weeks. By the third month, there was >20% reduction in MME compared with a 9% reduction in MME with placebo.
“Analyses indicated that patients treated with tofacitinib are likely to have significant reductions in medical expenditures,” Ms Rendas-Baum stated when asked about the long-term implications of the study results. “Rheumatoid arthritis will continue to worsen if left untreated so the relative gains for these patients should be greater in the long-term.”