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Abstract
Background The cost of Bio therapy has become a major problem in health economics and is unaffordable for some patients. Thus, it is important to consider whether we should discontinue or extend the interval of Bio. At EULAR 2016, we reported that maintaining disease activity, radiographic progression, and physical function via Bio-holiday therapy in rheumatoid arthritis (RA) patients with clinical disease activity index (CDAI) remission under a tight control strategy is possible. Osteoporosis is another issue for RA patients. RA patients generally develop osteoporosis more frequently than healthy individuals because of increased bone resorption and inhibited bone formation.
Objectives To investigate bone metabolism markers and bone mass index of RA patients with CDAI remission who underwent Bio-holiday therapy.
Methods Sixty-four RA patients with CDAI remission were included and were classified into two groups. Bio-holiday group (group H) comprised 34 patients [golimumab (GLM) and tocilizumab (TCZ), 18 and 16 patients, respectively] and in which patients were taken off Bio if they achieved CDAI remission. Patients visited our clinic at least once every 2 months and were treated with Bio within 3 months after falling out of CDAI remission. They could be taken off Bio again when they reached CDAI remission. The Bio group (group C) comprised 30 patients (GLM and TCZ, 16 and 14 patients, respectively). The mean ages of groups H and C were 52.9 and 55.6 years, respectively, and the mean disease durations were 3.98 and 4.13 years, respectively. There were no statistical differences between the backgrounds of the two groups. We compared the change in bone metabolism makers [urine type I collagen cross-linked N-telopeptide (NTX), serum tartrate-resistant acid phosphatase 5b (TRACP5b), serum bone-specific alkaline phosphatase (BAP), and serum osteocalcin (OC)] and bone mineral density (BMD) of lumber spine (L-spine) and femoral neck (FN) between both groups for 2 years.
Results The mean withdrawal periods were 12.1 and 8.8 months with GLM and TCZ, respectively. Three and four patients dropped out because of financial constraints in the in the groups H and C, respectively. One patient in each group dropped out because of RA flare-up. No patients in either group discontinued their therapy because of adverse events. Besides one patient who dropped out because of RA flare-up, all remaining patients in the group H were able to achieve CDAI remission without delay. There were no statistical differences in CDAI throughout the study period (Fig.1). There were no statistical differences in any of the bone metabolism makers throughout the study period (Table.1) and BMD of L-spine (Fig. 2(a)) and FN (Fig. 2(b)) at baseline and last evaluation.
Conclusions We conclude that maintaining disease activity bone metabolism status via Bio-holiday therapy for RA patients with CDAI remission under a tight control strategy is possible. Given that the flare-up rate in RA patients with deep remission is not high, it is not difficult to resume Bio therapy and gain CDAI remission. Furthermore, this treatment is financially durable. Therefore, we recommend Bio-holiday therapy.
Disclosure of Interest None declared