Abstract
Background
Strategic drug therapy for rheumatoid arthritis (RA) patients with prolonged remission is not well defined. According to recent guidelines, tapering biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) may be considered. We aimed to evaluate the long-term maintenance of tocilizumab (TCZ) treatment after the progressive tapering of infusions.
Methods
We conducted an exploratory, prospective, single-center, open label study, on RA patients with sustained remission for at least 3 months and treated with TCZ infusions every 4 weeks. The initial re-treatment interval was 6 weeks for the first 3 months. Thereafter, the spacing between infusions was determined by the clinician. Successful long-term maintenance following the tapering of TCZ infusions was defined by patients still treated after two years by TCZ with a minimum dosing interval of 5 weeks.
Results
Thirteen patients were enrolled in the study. Eight out of thirteen were still treated by TCZ after two years. Successful long-term maintenance was possible in six patients, with four patients maintaining a re-treatment interval of 8-weeks or more. We observed 5 patients with TCZ withdrawal: one for adverse drug reaction (neutropenia) and four with secondary failure. Patients achieving successful long-term maintenance with TCZ were significantly younger than those with secondary failure (p<0.05). In addition, RA patients with positive rheumatoid factor and anti-citrullinated peptide antibodies, experienced a significantly greater number of flares during our 2-year follow-up (p<0.01).
Conclusions
A progressive tapering of TCZ infusions seems possible in most of the patients. However, larger studies, including more patients, are needed to confirm this therapeutic option.
Delgocitinib ointment in pediatric patients with atopic dermatitis: a phase 3, randomized, double-blind, vehicle-controlled study and a subsequent open-label, long-term study
