Evaluación de la Actividad de la Enfermedad en Pacientes con Artritis Reumatoide Tratados con Tofactinib por RAPID3: Análisis Post Hoc de Dos Ensayos fase 3
Patients given tofacitinib (TOF) who achieved Routine Assessment of Patient Index Data 3 (RAPID3) remission or low disease activity (LDA) at 6 months, had improved long-term outcomes at 2 years, compared to patients with moderate or high disease activity (MDA/HDA) at 6 months.
RAPID3¹ is a patient-reported evaluation of disease activity, based on pooled PROs; patient global assessment, patient assessment of arthritic pain and HAQ-DI scores. Previous studies with tocilizumab have suggested that RAPID3 is a good predictor of long-term functional and radiographic responses². In this study, the authors analysed the long-term outcomes of patients given TOF based on RAPID3 responses at 6 months.
Data were analysed from two, 2-year, Phase 3 TOF studies: ORAL Start and ORAL Scan. RAPID3 scores were calculated at baseline, 6 months and 2 years. At 2 years, CDAI and HAQ-DI responses stratified by RAPID3 responses at 6 months, were assessed. Disease activity levels were defined as remission, LDA, MDA, or HDA.
Patients given TOF had higher rates of RAPID3 remission and LDA at 6 months, compared with methotrexate (MTX) and placebo patients, with a higher number of responses observed for TOF 10 mg BID vs TOF 5 mg BID.
At 2 years, more than 50% of patients given either TOF 5 or 10 mg BID were in RAPID3 and CDAI remission. During this time, over 65% of patients given TOF who were in RAPID3 remission, achieved normative HAQ-DI values and halted radiographic progression.
The findings of this study supported the previous study by Khawaja et al, which suggested that RAPID3 was a useful tool to measure disease activity and long-term patient outcomes. The data also showed that patients given TOF who achieved RAPID3 remission and LDA after 6 months of treatment, had improved long-term outcomes including normative HAQ-DI scores and improved CDAI responses.
1. Pinus et al. Arthritis Rheum 2003 48:625–30
2. Khawaja et al. Arthritis Care Res (Hoboken) 2017 69:609–15.