Objectives To evaluate the cost-effectiveness of biologics and methotrexate (MTX) for rheumatoid arthritis (RA) using the number needed to treat (NNT) concept and total actual health care cost. Methods This study included 121 RA patients with newly prescribed biologics and/or MTX between 2012 and 2017. The NNT was calculated based on the 24 week remission rate of Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAI). Results Remission rates were 76.4% for DAS28-ESR and 45.4% for CDAI in the biologics group and 63.6% and 24.2%, respectively, in the MTX group. The NNT was calculated as 6.4 and 4.2 in the biologics group and 34.2 and 35.2 in the MTX group, respectively. Mean total actual health care costs were 1,044,066 JPY (9835 US$)/24 weeks per treated patient in the biologics group and 75,860 JPY (715 US$)/24 weeks in the MTX group. Although the effectiveness of biologics was superior to MTX from the standpoint of NNT, the mean total health care cost and mean cost per NNT were much higher in the biologics group. Conclusions Cost-effectiveness is clearly higher for MTX than biologics from the standpoint of mean total health care cost per adjusted NNT under the Japanese health insurance system.
Background:Iguratimod (IGU) was started development as new non-steroidal anti-inflammatory drugs (NSAIDs), but it was changed for development as disease modifying antirheumatic drugs (DMARDs) because it showed suppression of inflammatory cytokine and inflammatory parameter which was not to be found in existing NSAIDs in the early stage of pharmacological study of drug efficacy. Although the clinical efficacy and the safety of IGU were already reported, the efficacy for elderly cases was not sufficiently analyzed.Objectives:In this study, we compared the efficacy of IGU in elderly group with the non-elderly group.Methods:190 patients who were able to continuously administer IGU more than three months was included. Cases were divided into two groups. Group A (75 years or older) includes 57 patients, and Group B (younger than 75 years) includes 133 patients. The patients background, the use of methotrexate (MTX) and glucocorticoid, the change of serum CRP, and the DAS28-ESR (before, 6, 12, and 24 months) as an evaluation of the disease activity were compared between two groups. The study protocol was approved by our institutional review board. All the patients were required to give written informed consent.Results:The average age at the beginning of IGU was 79.9±4.1 years old in Group A, and 59.9±10.6 years old in Group B. The average disease duration was 14.8±16.5 year in Group A and 8.5±10.6 year in Group B (p<0.01). Although the rate of concomitant use of MTX was significantly lower in Group A (Group A; 28.1%, Group B; 56.4%), the averaged dose of MTX did not show difference between groups (7.0 and 8.4 mg/week, respectively). Group A showed significantly higher rate of concomitant use of glucocorticoid (56.1%, and 36.1%, respectively), but the averaged dose of glucocorticoid did not show a difference between groups (4.3 and 3.6mg/day, respectively). Similarly, the rate of concomitant use of NSAIDs did not have a difference in two groups. Group A showed significantly higher serum CRP at the beginning of the IGU (Group A; 2.0 mg/dl, Group B; 1.2 mg/dl), but there was no difference after six months. In both groups, serum CRP was significantly decreased when compared at the beginning of IGU. After six months of IGU administration, both groups showed good clinical performance with DAS28-ESR, more than 60% of the cases showed remission or low disease activity. No difference of DAS28-ESR scores between two groups was observed after six months.Conclusion:From the results of this study, the efficacy of IGU for elderly patients was confirmed and did not show differences with non-elderly people. IGU is an inexpensive drug with enough efficacy and thought to be possible substitute for cases with insufficient reaction with other DMARDs.References:[1]Nozaki Y, et al. Modern Rheumatology 1439-7595, 2019.[2]Yoshikawa A, et al. Mod Rheumatol 28: 227-234, 2018.Disclosure of Interests:None declared
Aim To identify risk factors for relapse after methotrexate (MTX) dose reduction in rheumatoid arthritis (RA) patients receiving golimumab (GLM)/MTX combination therapy. Method Data on RA patients ≥20 years old receiving GLM (50 mg) + MTX for ≥6 months were retrospectively collected. MTX dose reduction was defined as a reduction of ≥12 mg from the total dose within 12 weeks of the maximum dose (≥1 mg/wk average). Relapse was defined as Disease Activity Score in 28 joints using C‐reactive protein level (DAS28‐CRP) score ≥3.2 or sustained (≥ twice) increase of ≥0.6 from baseline. Results A total of 304 eligible patients were included. Among the MTX‐reduction group (n = 125), 16.8% of patients relapsed. Age, duration from diagnosis to the initiation of GLM, baseline MTX dose, and DAS28‐CRP were comparable between relapse and no‐relapse groups. The adjusted odds ratio (aOR) of relapse after MTX reduction was 4.37 (95% CI 1.16–16.38, P = 0.03) for prior use of non‐steroidal anti‐inflammatory drugs (NSAIDs), and the aORs for cardiovascular disease (CVD), gastrointestinal disease and liver disease were 2.36, 2.28, and 3.03, respectively. Compared to the non‐reduction group, the MTX‐reduction group had a higher proportion of patients with CVD (17.6% vs 7.3%, P = 0.02) and a lower proportion of prior use of biologic disease‐modifying antirheumatic drugs (11.2% vs. 24.0%, P = 0.0076). Conclusion Attention should be given to RA patients with history of CVD, gastrointestinal disease, liver disease, or prior NSAIDs‐use when considering MTX dose reduction to ensure benefits outweigh the risks of relapse.
Objectives: To evaluate the cost-effectiveness of biologics and methotrexate (MTX) for rheumatoid arthritis (RA) using the number needed to treat (NNT) concept and total actual health care cost.Methods: This study included 121 RA patients with newly prescribed biologics and/or MTX between 2012 and 2017. The NNT was calculated based on the 24-week remission rate of Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAI).Results: Remission rates were 76.4% for DAS28-ESR and 45.4% for CDAI in the biologics group and 63.6% and 24.2%, respectively, in the MTX group. The NNT was calculated as 6.4 and 4.2 in the biologics group and 34.2 and 35.2 in the MTX group, respectively. Mean total actual health care costs were 1,044,066 JPY (9,835 US$)/24 weeks per treated patient in the biologics group and 75,860 JPY (715 US$)/24 weeks in the MTX group. Although the effectiveness of biologics was superior to MTX from the standpoint of NNT, the mean total health care cost and mean cost per NNT were much higher in the biologics group.Conclusions: Cost-effectiveness is clearly higher for MTX than biologics from the standpoint of NNT and total actual health care cost under the Japanese health insurance system.
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