Objectives To assess real-life practice patterns of biologic discontinuation, including tocilizumab, for good response and factors associated with retreatment, we conducted a research on the Cohort of Arthritis, Biologic Users at Kameda Institute (CABUKI) registry .
Methods Proportions of patients who discontinued biologic agents for physician-perceived good response were calculated for each biologic agent. Baseline characteristics were compared to patients whose biologics were withdrawn for ineffectiveness or side effects. Disease and treatment characteristics at discontinuation for good response were compared to recommendations. Survival of biologic-free status and predictors of retreatment were analyzed.
Results Among 265 eligible patients, 161 patients (ADA 3, ETN 58, IFX 77, TCZ 23) who discontinued their biologics during the study period were identified: 35 for good response (ADA1, ETN9, IFX22, TCZ3), 53 for side effects (ADA2, ETN21, IFX22, TCZ8), 39 for ineffectiveness (ETN11, IFX21, TCZ7), and 34 for other reasons [patient’s preference 24 (ETN11, IFX10, TCZ3), physician preference 9 (ETN5, IFX2, TCZ2), and unspecified 1 (ETN1)]. Age at initiation was lowest in the good response group and highest in the side effects group, and baseline prednisolone dose was highest in the ineffectiveness group. Patients in the good response group had been treated with biologics for 20 months on average, topping other groups. Prednisolone was used at the lowest dose in this group. Methotrexate doses were significantly lower in the side effects group. Among 35 patients in the good response group, 21 (60%) met DAS28-ESR criteria (5 patient lacked patient’s global assessment required for DAS28-ESR, thus were regarded as non-responders), and 27 (77%) met the DAS28-ESR low disease activity criteria (<3.2). ACR/EULAR 2011 Boolean remission criteria for clinical practice were stricter with only 13 (37%) of the patients meeting the requirement, and was due to swollen joint count >1 and patient global assessment >10 out of 100. First-line infliximab and adalimumab achieved the highest good response discontinuation rates at 22.5% and 25.0%, respectively, whereas first-line tocilizumab and etanercept achieved 10.5% and 7.6%, respectively. Among those who became biologic-free, 70.5% remained so at 6 months. Achievement of prednisolone-free status six or more months before biologic discontinuation was associated with longer biologic-free status (Table).
Conclusions Biologic-free status is an achievable goal in routine practice. Stabilization of disease activity without prednisolone for more than six months is an important factor.
Yoshida K, et al. An observational study of tocilizumab and TNF-alpha inhibitor use in a Japanese community hospital: different remission rates, similar drug survival and safety. Rheumatology (Oxford). 2011;50:2093-2099.
Disclosure of Interest None Declared