Single center prospective study of tacrolimus efficacy and safety in treatment of rheumatoid arthritis

Abstract

The aim of this study was to prospectively evaluate the efficacy and safety of tacrolimus for treating rheumatoid arthritis (RA) patients in clinical practice. Fifty-five active RA patients who had been resistant or intolerant to other disease-modifying antirheumatic drugs were enrolled in this open-label trial. Patients were administered tacrolimus at a dosage of 1, 2 or 3 mg once daily, and followed up for 24 weeks. They were divided into three groups according to their dosage. Efficacy and safety were evaluated utilizing clinical and laboratory findings. Eighty percent of the patients had moderate or high disease activity; 55% were elderly and 53% had complications; 65% of the patients were started on tacrolimus as a monotherapy. Moderate or good response rates were achieved as follows: 38.2% (4 weeks); 41.8% (12 weeks); and 45.6% (24 weeks). Adverse events were observed in seven cases (12.7%). Only one case required hospitalization due to severe hyperglycemia caused by a high tacrolimus concentration (24.2 ng/ml); we suspected a drug interaction in this subject. Mean concentrations were dose-dependent in the 1, 2, and 3 mg/day groups (2.96, 4.29, and 8.32 ng/ml, respectively). Four cases of high concentration (over 10 ng/ml), without any signs or symptoms, were observed in the 3 mg/day group; in these cases, doses were decreased and no severe adverse events occurred. Tacrolimus was found to be both effective and safe in treating active RA patients with complicated backgrounds in clinical practice. Blood concentration measurements and dose adjustments should be performed to prevent severe adverse events in a 3 mg/day group.

Single center prospective study of tacrolimus efficacy and safety in the treatment of various manifestations in systemic lupus erythematosus

“…We were able to conWrm a drug response for these manifestations at 4 weeks, the same as in our report on RA [16]. Our results also indicate that it possesses steroid-sparing eVects and makes a good combination partner in a subgroup of patients that responded well to the therapy.…”

“…In 2004, the use of TAC for the treatment of rheumatoid arthritis (RA) had been approved in Canada and Japan. A great deal of clinical evidence was accumulated, including our reports on RA [13][14][15][16]. More recently, in 2006, TAC was approved for lupus nephritis with intolerance to be the previously normal treatment in Japan, Wrst in the world.…”

Clinical Assessment of Tacrolimus Therapy in Lupus Nephritis: One-Year Follow-Up Study in a Single Center

“…The prednisolone dose was tapered by 5 to 10 mg/day until the dose reached to 20 mg/day, after that it was reduced by 2.5 mg/day until a maintenance dose of 10 mg/day was reached. To justify the tacrolimus dose, we referred to a prospective study of tacrolimus efficacy and safety in the treatment of rheumatoid arthritis [20]. The efficacy and safety have been confirmed when patients with rheumatoid arthritis were administered tacrolimus at a dosage of 3 mg once a day in the evening.…”

Successful treatment with clarithromycin and/or tacrolimus for two patients with polymyalgia rheumatica

“…Recent cases of lupus nephritis and adultonset Still's disease were successfully treated using TAC; in those cases, CAM was administered in order to increase the concentration of TAC in the blood (9,10). Suzuki et al measured the concentration of TAC in the blood of patients with RA, and they found that the concentration of TAC in the blood was 2.96 ng/ mL in patients receiving a dose of 1 mg/day, 4.29 ng/ mL in patients receiving a dose of 2 mg/day, and 8.32 ng/mL in patients receiving a dose of 3 mg/day (11). However, the concentration varied widely in individual patients in those three groups.…”