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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.

Purpose To investigate the prevalence and risk factors of cervical lesions in patients with rheumatoid arthritis (RA) under current pharmacological treatments with biological agents. Methods One hundred and eighty-five consecutive patients with RA who underwent both cervical plain radiography and bone mineral density (BMD) scanning were enrolled. RA cervical lesions included atlantoaxial subluxation (AAS), vertical subluxation (VS), and subaxial subluxation (SAS). We assigned patients with AAS, VS, or SAS to the cervical-lesion group, and all other patients to the non-cervical-lesion group. Radiological findings, BMD, and clinical data on RA were collected. We used multivariate logistic regression analyses to assess the risk factors of cervical lesions in patients with RA. Results The cervical-lesion and non-cervical-lesion groups included 106 and 79 patients, respectively. There were 79 patients with AAS, 31 with VS, and 41 with SAS. The cervical-lesion group had younger age of onset, longer RA disease duration, and lower femoral neck BMD than those in the non-cervical-lesion group. Multivariate analyses showed that the risk factors of RA cervical lesions were RA disease duration, prednisolone usage, biological agents, and femoral neck BMD. Femoral neck BMD in patients with VS was lower than in those without VS. Conclusions Cervical lesions were confirmed in 57% of the patients. RA duration, prednisolone usage, biological agents, and femoral neck BMD were significant risk factors of cervical lesions in patients with RA. The general status of osteoporosis might contribute to the development of VS.

Background Few reports have described the association between rheumatoid arthritis (RA) cervical lesions and osteoporosis, especially in patients with vertical subluxation (VS) that could be induced by the collapse of lateral masses in the upper cervical spine. Therefore, this study aimed to investigate the prevalence and risk factors for cervical lesions in patients with RA under current pharmacological treatments with biological agents, and to investigate the relationship between osteoporosis and VS development. Methods One hundred eighty-five consecutive patients with RA who underwent both cervical plain radiography and bone mineral density (BMD) scanning were enrolled. RA cervical lesions included atlantoaxial subluxation (AAS), VS, and subaxial subluxation (SAS). We assigned patients with AAS, VS, or SAS to the cervical-lesion group, and all other patients to the non-cervical-lesion group. Radiological findings, BMD, and clinical data on RA were collected. We used multivariate logistic regression analyses to assess the risk factors for cervical lesions in patients with RA. Results The cervical-lesion and non-cervical-lesion groups included 106 and 79 patients, respectively. There were 79 patients with AAS, 31 with VS, and 41 with SAS. The cervical-lesion group had a younger age of RA onset, longer RA disease duration, higher RA stage, and lower femoral neck BMD than the non-cervical-lesion group. Multivariate analyses showed that the risk factors for RA cervical lesions were prednisolone usage, biological agent usage, and higher RA stage. Prednisolone usage and femoral neck BMD were the risk factors for VS. Conclusions Cervical lesions were confirmed in 57 % of the patients. Prednisolone usage, biological agent usage, and higher RA stage were significant risk factors for cervical lesions in patients with RA. The general status of osteoporosis might contribute to the development of VS.

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 (pConclusion: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

Background Recently biologic agents are widely used for patients with rheumatoid arthritis (RA). Biologic agents are reported to have higher effectiveness than other disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX), however, those new agents are more expensive. Objectives This study evaluated the cost-effectiveness of biologic agents for RA using number needed to treat (NNT) method. NNT is an index for determining the number of patients who need to be treated in order to reach a patient toward to clinical goal when a new treatment is introduced. Methods Fifty-three patients with RA was included in this study. These patients were introduced biologic agents between September 2012 to ,March 2017and continued same agent up to 24 weeks. NNT was calculated based on disease activity score (DAS28-ESR) and clinical disease activity index (CDAI) at 24 weeks. Ninety-four patients were investigated as a control group who treated with DMARDs. In addition, actual healthcare cost including doctor’s fee, laboratory examination, prescription fee, and cost of biologic agents in each patient were calculated based on hospital’s medical receipt, then averaged and compared between two groups. Results In biologic group, tocilizumab (TCZ) were used for 20 patients, golimmab (GLM) for 14 patients, etanercept (ETN) for 13 patients, and other biologics for six patients. In control group, 66 patients administered MTX and/or conventional DMARDs (csDMARDs), and 28 patients administered only csDMARDs. In biologic group, 53 patients (79.2%) achieved remission in DAS28-ESR, and 24 patients (45.2%) achieved remission in CDAI. On the other hand, the rate of remission was 61.7% and 23.4% respectively in control group. NNT was 1.26 (DAS28) and 2.21 (CDAI) in biologic group, and 1.62 and 4.27 respectively in control group. In biologic group, NNT based on DAS28-ESR of each agent was 1.11 of TCZ, 1.30 of ETN, 1.40 of GLM, and 1.50 of others (table 1). The total actual healthcare cost in the study period was 7,812.5 Euro (1044066 JPY; 1 Euro=133.6 JPY, in December 2017) in biologic group and 583.8 Euro (78020 JPY) in control group. Conclusions The total actual health care cost of biologic group was much higher than DMARDs group, however, the cost-effectiveness of biologics was superior to DMARDs from the stand point of NNT. Reference [1] Alberto B, et al. Efficacy and Treatment Costs of Monotherapy with bDMARDs in the Treatment of Rheumatoid Arthritis in Patients Intolerant to or Inappropriate to Continue Treatment with Methotrexate. Adv Ther2016;33:1360–73. Disclosure of Interest K. Harigane: None declared, Y. Mochida: None declared, K. Sahara Grant/research support from: Takeda Pharmaceutical Company Limited, Daiichi Sankyo Company, Limited, Mitsubishi Tanabe Pharma Corporation, Teijin Limited Chugai Pharmaceutical Co., Ltd, Astellas Pharma Inc., N. Mitsugi: None declared

Background: Abatacept (ABT) is clinically used as the only T-cell modifier available for rheumatoid arthritis treatment and has shown similar efficacy as tumour necrosis factor inhibitors and a safer profile, especially a lower infection ratio in registry data. Latourte et al. recently published the results of perioperative complications of orthopaedic and other types of surgery in patients using ABT. However, they did not compare the complication rates with those in patients who received csDMARDs. It remains unknown whether ABT is associated with more postoperative complications than conventional synthetic DMARDs (csDMARDs). Objectives: The aims of this study were to investigate whether ABT is associated with more adverse events after orthopaedic surgery compared with csDMARDs and, if so, to identify significant risk factors for those events. Methods: A retrospective multicenter nested case–control study was performed in 18 institutions. Patients receiving ABT were matched individually with patients receiving csDMARDs and/or steroid. Serious adverse events were defined as surgical site infection, delayed wound healing, deep vein thrombosis or pulmonary embolism, flare-up, serious infection in other organs. The incidence rates of serious adverse events in both groups were compared with Mantel-Haenzel test. Risk factors for serious adverse events in the ABT group were analyzed by logistic regression model. Results: A total of 3358 cases were collected. After inclusion and exclusion, 2651 patients were selected for matching, and 194 patients in 97 pairs were chosen for subsequent comparative analyses between the ABT and control groups. No between-group differences were detected in the incidence rates of each adverse event or in the combined incidence rate of adverse events. The odds ratio of the history of serious infection for serious adverse events was 12.6 (95%CI 1.12–141, P=0.04) in patients who received ABT and underwent orthopaedic surgery. Conclusions: Compared with csDMARDs and/or steroid without ABT, adding ABT to the treatment does not appear to increase the incidence rates of postoperative adverse events in rheumatoid arthritis patients undergoing orthopaedic surgery. A history of serious infection is a significant risk factor for both infection and other serious adverse events, and such patients should be treated with particular caution. Reference [1]Latourte A, et al. Safety of surgery in patients with rheumatoid arthritis treated by abatacept: data from the French Orencia in Rheumatoid Arthritis Registry. Rheumatology (Oxford)2017Apr 1;56(4):629–637. Disclosure of Interest: H. Ito Grant/research support from: BMS, ONO Pharmaceutical, S. Tsuji: None declared, M. Nakayama: None declared, Y. Mochida: None declared, K. Nishida: None declared, H. Ishikawa: None declared, T. Kojima: None declared, T. Matsumoto: None declared, A. Kubota: None declared, T. Mochizuki: None declared, K. Sakuraba: None declared, I. Matsushita: None declared, A. Nakajima: None declared, R. Hara: None declared, A. Haraguchi: None declared, T. Matsubara: None declared, K. Kanbe: None declared, N. Nakagawa: None declared, M. Haraguchi: None declared, S. Momohara: None declared

Background Several studies reported that development of phaemacological treatment for rheumatoid arthritis (RA) contributed to decreased number of orthopaedic surgery. [1–3] Surgical treatment is, however, still required in many cases, and the impact of orthopaedic surgery on disease activity remain unclear. Objectives This study evaluated the effect of total knee arthroplasty (TKA) with capsulosynovectomy on chenges of disease activity and medication in patients with RA. Methods Seventy-seven serial patients with RA (61 female and 16 male) who underwent primary TKA with more than one year of follow-up were retrospectively reviewed to assess postoperative disease activity and drug administration. The mean age at the time of surgery was 68.3 years old. The disease activity of RA was measured using Disease Activity Score in 28 Joints (DAS28). To evaluate the effects of medication on preoperative and postoperative disease activity, outcomes at before surgery and one year after surgery were separately investigated following two groups; patients who were treated with the same or reduced medication (same group) and patients who were administered with additional or altered medication (change group). Results Seventy-two patients (97.3%) were administered with at least one DMRDs before or after surgery. The mean dose of methotrexate (MTX) was 7.7mg/week before surgery and 8.0mg/week after surgery respectively. The number of patients who were treated with biological DMARDs was increased after surgery (17 patients vs.21 patients), however there was not significant differences. RA disease activity was significantly decreased in DAS28-CRP one year after surgery. (3.9 vs. 2.7, p Conclusions TKA with capsulosynovectomy improves disease activity after surgery in patients with RA. Based on the results, patients with higher disease activity before surgery required further medication after surgery. References Dusad A et al. Impact of Total Knee Arthroplasty as Assessed Using Patient-Reported Pain and Health-Related Quality of Life Indices: Rheumatoid Arthritis Versus Osteoarthritis. Arthritis Rheumatol. 2015; 67: 2503–11. Yano K et al. Effect of total knee arthroplasty on disease activity in patients with established rheumatoid arthritis: 3-year follow-up results of combined medical therapy and surgical intervention. Mod Rheumatol. 2010; 20: 452–7. Oh K et al. Effects of surgical intervention on disease activity of rheumatoid arthritis: cases of surgery for rheumatoid arthritis of the lower limbs treated with biologics. Mod Rheumatol. 2014; 24: 606–11. Disclosure of Interest None declared

Background Several studies reported that development of phaemacological treatment for rheumatoid arthritis (RA) contributed to decreased number of orthopaedic surgery. [1–3] Surgical treatment is, however, still required in many cases, and the impact of orthopaedic surgery on disease activity remain unclear. Objectives The aims of current study was to evaluate the effect of total knee arthroplasty (TKA) with capsulosynovectomy on changes of disease activity and knee function after TKA in patients with RA. Methods Seventy-seven serial patients with RA (61 female and 16 male) who underwent primary TKA with more than one year of follow-up were retrospectively reviewed to assess postoperative disease activity and knee function. The mean age at the time of surgery was 68.3 years old. The disease activity of RA was measured using Disease Activity Score in 28 Joints (DAS28). Clinical outcome was measured by treatment score for RA knee of the Japanese Orthopaedic Association (JOA) score. To evaluate the effects of disease activity on knee function, outcomes at before and one year after surgery were separately investigated following two groups; patients who had remission or low disease activity in DAS28-CRP (good controlled group), and patients who had moderate or high disease activity (poor controlled group) one year after surgery. Results The disease activity of RA was significantly decreased in DAS28-CRP one year after surgery. (3.9 vs. 2.7, p Conclusions TKA with capsulosynovectomy improves both knee function and disease activity in patients with RA. Based on the results, knee function after TKA is influenced with disease activity. References Dusad A et al. Impact of Total Knee Arthroplasty as Assessed Using Patient-Reported Pain and Health-Related Quality of Life Indices: Rheumatoid Arthritis Versus Osteoarthritis. Arthritis Rheumatol. 2015; 67: 2503–11. Yano K et al. Effect of total knee arthroplasty on disease activity in patients with established rheumatoid arthritis: 3-year follow-up results of combined medical therapy and surgical intervention. Mod Rheumatol. 2010; 20: 452–7. Oh K et al. Effects of surgical intervention on disease activity of rheumatoid arthritis: cases of surgery for rheumatoid arthritis of the lower limbs treated with biologics. Mod Rheumatol. 2014; 24: 606–11. Disclosure of Interest None declared

Background and purpose Synovectomy is an effective procedure for management of the rheumatoid elbow at radiographically early stages (Larsen grades 1 and 2). However, its efficacy for advanced stages (Larsen grades 3–5) is controversial. We investigated the outcome of synovectomy for advanced stages of the rheumatoid elbow. Methods Between May 1985 and September 1994, synovectomy was performed for 67 rheumatoid elbows in 59 patients (mean age 52 (26–72) years, 54 women). 3 elbows (3 patients) were lost to follow-up after mean 15 (10–23) years. Thus, 64 elbows were evaluated clinically and radiographically. Results The mean Mayo elbow performance score (MEPS) improved from 42 (15–75) points preoperatively to 78 (45–100) points at the final follow-up examination. In cases of Larsen grade 5, the mean MEPS at final follow-up examination (69 points) was lower than those of Larsen grade 3 and 4 cases (80 and 79 points, respectively) (p < 0.01). Recurrence of synovitis was obvious in 20/67 elbows. 12 cases had a...

Since biologic agents were introduced to treat rheumatoid arthritis (RA) in 2003, the number of orthopedic surgical procedures under treatment with biologic agents has been increasing in Japan. However, whether biologic agents cause an increase in the prevalence of postoperative complications is as yet unknown. The Committee on Arthritis of the Japanese Orthopedic Association investigated the prevalence of postoperative complications in patients with RA in teaching hospitals in Japan.Between January 2004 and November 2008, surveillance forms about medications and surgical procedures in patients with RA were sent to 2,019 teaching hospitals. Data were analyzed by the Rheumatoid Arthritis Committee.Biologic agents were administered to RA patients in 632 of 1,245 hospitals (50.8%); 430 of the 1,245 hospitals (34.5%) used surgical intervention under treatment with biologic agents. The number of surgical procedures under treatment with biologic agents was 3,468, and the prevalence of infection was 1.3% (46 cases). The prevalence of infection was 1.0% (567 procedures) in 56,339 procedures under treatment with nonbiologic disease-modifying anti-rheumatic drugs. There were no significant differences between biological and nonbiological treatment groups with respect to the prevalence of infection. In the joint arthroplasty group, the number of procedures under biological and nonbiological treatment was 1,626 and 29,903, and the prevalence of infection was 2.1% (34 procedures) and 1.0% (298 procedures), respectively. There was a significant difference between groups. The odds ratio was 2.12 (95% confidence interval 1.48-3.03, P0.0001).The chance of having biological treatment with joint arthroplasty was more than twofold greater in patients with surgical-site infections compared with those treated with nonbiologic agents. Caution is required for surgical procedure, perioperative course, and obtaining consent for joint arthroplasty for patients with RA undergoing surgery under biological agents.

Background The mobile bearing knee system was introduced to lessen contact stress on the articular bearing surface and reduce polyethylene wear. The purpose of the current study was to investigate the mid-term results of patients undergoing total knee arthroplasties (TKAs) using Scorpio Plus Mobile Bearing Knee System (Stryker, Mahwah, NJ), and compare the outcomes between patients with osteoarthritis and osteonecrosis (OA·ON group) and patients with rheumatoid arthritis (RA group). Methods Eight males and 58 females were followed up for a period of 4.4- 7.6 years from June 1, 2003 to December 31, 2005. There were 53 knees with osteoarthritis, 17 knees with rheumatoid arthritis, and 6 knees with osteonecrosis. Clinical and radiographic follow- up was done using The Japanese Orthopedic Association knee rating score (JOA score) and Knee Society Total Knee Arthroplasty Roentgenographic Evaluation and Scoring System. Results With regard to the JOA score, there was significant improvement in both groups. The postoperative range of motion was between 0.8°and 116.8° in OA·ON group, and between 0.0° and 113.7° in RA group. There were no significant differences with the radiographic evaluation between two groups. Spontaneous dislocation of a polyethylene insert occurred in one patient, and deep infection was occurred in one patient. Conclusion There was significant improvement with regard to the clinical and radiographic results of patients undergoing TKAs using the model. The risk of polyethylene insert dislocation related to the mobile bearing TKA is a cause for concern.