Objective: The aging of modern Japanese society has progressed rapidly, and increased life expectancies resulting from the contributions of medical science has increased the proportion of the elderly among rheumatoid arthritis (RA) patients. Based on this observation, we investigated that the characteristic of quality of Life (QOL) for elderly RA patients.
    Method: 59 RA patients aged sixty five and over which had not contracted dementia were included in the study. They completed Arthritis Impact Measurement Scales version 2 (AIMS2) health status questionnaires. Various fields of QOL scores were compared.
    Results: The patients had high scores for “Walking and bending” and “Social activities”, but had low scores for “Support from family”. In each family structure, the scores for “Self care” and “Household tasks” were significantly higher for patients in large families than for patients living alone.
    Conclusion: Elderly RA patients assessed themselves highly for “Self care” and “Household tasks” when living alone. Aged RA patients can often establish their own lifestyles, and the patient’s lifestyle, equipment for making their environment easier to live in, and rethinking of consideration for them are required especially fron their families.

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    The methotrexate scored tablet, Metolate^® tablet 2 mg (MTL), was developed for use by patients with rheumatoid arthritis (RA) in Japan as a generic version of the methotrexate capsule, Rheumatrex^® capsule 2 mg (brand-name drug). Therefore, MTL had no clinical evidence for use with RA patients until we conducted a post-marketing observational study to collect clinical data concerning the safety and efficacy of the drug. On the other hand, we conducted another post-marketing observational study of switchover to MTL in stable RA patients previously on long term brand-name drug therapy to confirm the therapeutic equivalence of the two formulations and the patient satisfaction with the MTL substitution. As a result, no significant differences were seen in the duration of morning stiffness, CRP and ESR levels, grip strength, tender and joint counts, DAS28(3)-CRP, or DAS28(3)-ESR three months before and after MTL substitution. For safety, the incidence of adverse drug reactions (ADR) was 6.2% (22/357) after MTL substitution and most ADR were common in brand-name drug therapy as well. Patient satisfaction with the MTL substitution was assessed by investigators asking the patient to compare it with the brand-name drug. Most patients were satisfied that the MTL substitution had caused “no change” and more patients believed their situation had “improved” than “worsened”. In conclusion, MTL was considered to be the therapeutically equivalent to the brandname drug.

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    To analyze drug-free remission cases after treatment with infliximab, we investigated 21 remission cases out of 135 patients with established RA who had discontinued use of infliximab. Infliximab was discontinued when a negative CRP and negative MMP-3, below 2.6 points of DAS28, were continuously obtained for more than 6 months. Out of 135 patients, 40%(54/135) were in remission, 38.8%(21/54) stopped infliximab for remission, and 19%(4/21) showed drug-free remission among the patients stopped infliximab by remission. Drug-free remission which does not need all medical drugs including biologics, MTX, PSL, DMARDS and NSAIDS is different from clinical remission in terms of the definition. The continuous rate of remission after stopping infliximab was 66% at1years, by the Kaplan-Meier method. Of the four cases, no case showed increased CRP levels 18 months after discontinuing infliximab showing drug-free remission. Average disease duration of drug-free cases was 21.25 months. The MMP-3 levels and RAPA showed low level before and after drug-free remission. Therefore, the patients of early RA can accomplish drug-free remission by using infliximab before increasing MMP-3 and RAPA.

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    The aim of this study is to investigate the course of treatment by anti-tumor necrosis factor agents (infliximab and etanercept) in patients with rheumatoid arthritis (RA) and to compare results with each other. 150 patients with RA treated in our institute from November in 2003 to May in 2008 were included. Drug survival rates and severe adverse events were investigated. Analysis of drug survival rates was performed using Kaplan-Meyer’s method and the Log-Rank test. Drug survival rates of both agents when used as both primary and secondary biologics were 79.4% at 12 months, 70.0% at 24 months, 52.5% at 36 months in the case of infliximab and 85.3% at 12 months,83.6% at 24 months, 79.4% at 36 months in the case of etanercept. Mean continuation periods were 26.4 months in the infliximab group and 30.7 months in the etanercept group and the difference was statistically significant (P＝0.04). However, there was no significant difference between two groups when analyzed using data on agents used as primary agents (26.2 months in infliximab group and 29.9 months in etanercept group). There was also no significant difference between the two groups when analyzed using data of agents used after etanercept was commercially available (27.9 months in infliximab group and 30.7 months in etanercept group). 2 cases treated with infliximab developed tuberculosis. 1 case treated with infliximab and 3 cases treated with etanercept died. This study suggested that results of drug survival rates were influenced by baseline characteristics of patients, time when agents were commercially available, dosage used in clinical practice and human anti-chimeric antibody to infliximab.

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    Objective: To evaluate the impact of etanercept therapy on the employment status of patients with rheumatoid arthritis (RA).
    Methods: There were totally 79 RA patients treated with etanercept in Tokyo Hakujuji Hospital and Yoshino memorial clinic.
    We focused on 20 patients, who had job with difficulty or got laid off at the time when the treatment was started. These patients background were as follows: male were 11, female were 9.
    Average age in this treatment was 52.1 years old (from 24 to 73). Average suffering period Was 75.1 months (from 12 to 240). Average follow up period was 19.1 (from 13 to 38 months). Their occupation ranged from self-employed 6, office worker 4, civil servant 3, taxi driver 1, shop assistant1, to welfare worker 2.
    Results: almost all patients’ job performance improved, especially 9 patients normalized after treatment. However, 3 patients were difficult to continue working. The reason was that1male had bad complications and the 2 other female could not work due to labor regulations. The average DAS28-ESR was 3.70 (from 3.25 to 4.86) before treatment and 2.41 (from 1.5 to 2.76) after treatment in the patients.
    This showed a very significant improvement(P＜0.01).
    In conclusion, etanercept is very effective for RA and makes it possible for patients to continue working. In addition, it is generally believed that both the indication and the decision to start the use of biological agents have a great impact on the employment status.

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Introduction
    Biologics have remarkable curative effects on rheumatoid arthritis (RA).
    Tocilizmab was approved on April 16, 2008, and the administration of the preparation began at our clinic in May.
    The clinical progress of tocilizmab has not been examined. We would like to report observations of cases of RA with tocilizmab made by physical therapists.
Object
    Two male and seven female patients (mean age of nine cases: 61.2 years).
Method
    The transition of numerical values of CRP and DAS28 was examined for 12 weeks immediately after tocilizmab was administered. The measurement of swelling of joints numerical values of VAS and measurement of joint motion were examined for the same period.
Clinical results
    The tocilizmab improved the numerical value of CRP remarkably in a week.
    It improved DAS28 gradually.
    Eight weeks later than the change in CRP and DAS28, swelling of joints was improved.
    12 weeks later than the change in CRP, VAS was improved.
    ROM was not improved.
Consideration and conclusion
    The curative effects of tocilizmab include remarkable improvement of the numerical value of CRP in a week, slow improvement of measurement of swelling of joints and VAS.ROM was not improved.
    Therefore, the clinical progress of tocilizmab seems to be different from other biologics.
    We conclude that satisfaction of the patient is obtained12weeks after administration of tocilizmab.

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    In order to clarify the effects of biologic disease modifying anti-rheumatic drugs (biologic DMARDs) and rehabilitation for patients with rheumatoid arthritis, we investigated disease activity, grip strength, upper limb disorder and Activities of Daily Living (ADL) classifying each of 30 patients who did not use biologic DMARDs and 28 patients who used biologic DMARDs into two groups of not having rehabilitative intervention and having rehabilitative intervention, respectively. The measurements were done before and one, three and six months after the intervention. The rehabilitation was set as “intensive training” having dual tracks of individual training that was performed five times in two weeks and self training, and “home training” to be performed at home after the program. Regardless of whether the biologic DMARDs was used, disease activity and upper limb disorder were significantly improved by the intervention with rehabilitation after one, three and six months. Also, improvement of grip strength for the group that used biologic DMARDs was maintained in a similar manner one month after the rehabilitation. On the other hand, no items were improved for the group that did not use biologic DMARDs and rehabilitation.
    The intervention of rehabilitation for the patients of rheumatoid arthritis was effective and its effectiveness seemed to contribute to better improvement when it was combined with use of biologic DMARDs.

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    Back ground: As patients with RA and metatarsalgia often have complications such as ankle joint instability, some patients complain of ankle joint pain when wearing a shoe inserted arch pad (the inserted arch pad). We developed a novel arch pad with an ankle sprain supporter regulated ankle joint instability (the strapped arch pad). In our previous study, the remission score of the severity index significantly improved in the participants wearing the strapped arch pad compared with that found in the group wearing the inserted arch pad. In follow-up, we assessed for the biomechanical effect of strapped arch pad on postural sway in this study.
    Methods: The twenty-nine outpatients with metatarsalgia of RA were enrolled. The posturographic variables including the envelopment area tracing by the movement of the center of pressure (E AREA) and distance of the movement of the center of pressure per second (LNG/TIME) was assessed for each subject while barefoot, when wearing a strapped arch pad, with an inserted arch pad and when wearing a medial wedged insert with ankle strapping (the strapped medial wedge).
    Results: The average E AREA with use of the strapped arch pad was significantly lower than those with use of the inserted arch pad or strapped medial wedge. The LNG/TIME when wearing a strapped arch pad was significantly reduced compared that with an inserted arch pad.
    Conclusion: The biomechnical balance improvement by strapped arch pad was agreeable to the clinical effect of the arch pad.

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    Fibromyalgia (FM) is a condition characterized by chronic and disabling pain. Since pain is commonly evaluated by a subjective assessment, it is difficult to evaluate the treatment effect objectively. In this report, the treatment outcome was evaluated by an objective assessment of pain in FM patients.
    Eight FM patients who fulfilled the American College of Rheumatology criteria for the classification of fibromyalgia participated. The severity of FM was assessed with the Japanese version of the Fibromyalgia Impact Questionnaire (JFIQ). The pain level was evaluated by pain degree, i.e., the magnitude of pain which was quantitatively measured with Pain Vision PS-2100^TM, and by visual analog scale (VAS). The treatment procedure involved the injection of a local anesthetic into bilateral lateral pterygoid muscles followed by the insertion of an oral device which restricted horizontal mandibular movements. In three cases, the treatment procedure was repeated and a clinical course was observed for 3-6 months.
    Pain degree and VAS were significantly reduced after the monotherapy. There was a significant correlation between pain degree and VAS. Pain degree, VAS and JFIQ were reduced in three cases in the follow-up period, although some fluctuations were observed.
    The pain relief procedure for lateral pterygoid muscles exhibited a significant effect on the reduction of systemic pain for temporomandibular disorder patients who fulfilled the classification criteria of FM, and could be considered as a treatment option for FM. It was also suggested that a quantitative measurement method for the magnitude of pain could be valuable for the evaluation of treatments for FM.

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    We had three cases of rheumatoid arthritis in whom we administered a biological agent with some, but insufficient, effects, who showed a response after a dose of tacrolimus was also given.
    Infriximab was used in two cases, etanercept in one. Since the effects of the biological agent were insufficient in each case, tacrolimus was additionally dosed. In all three cases, the condition went into remission, and we were able to further decrease the steroid dosage.
    Although, unlike MTX, an inhibitory effect on cell proliferation was not observed with tacrolimus, which has an inhibitory effect on the production of inflammatory cytokines such as TNFα. Therefore, when some (but insufficient) effects were observed after administration of the anti-TNFα agent, those effects of the biological agent could be recovered and enhanced by reducing the TNFα production with the additional dosage of tacrolimus. Tacrolimus also had an inhibitory effect on extracellular steroid excretion by competitively binding with P-glycoproteinon the lymphocyte surface. As a result, the intracellular steroid concentration increased, which led to the reduction of the steroid dosage.

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    Adult-onset Still’s disease (AOSD) is an inflammatory disease of unknown etiology. AOSD is typically characterized by a spiking fever, arthritis, rashes, leukocytosis, and involvement of various organs.
    We report a case of a 59-year-old Japanese male presenting rapid and progressive polyarthritis. He complained of bilateral knee joint pain and swelling of 3 months duration which was accompanied by a fever over 39°C for one month. On admission, he showed arthritis on bilateral MP, PIP, wrist, knee, and foot joints. X-ray study revealed distinct erosion of bilateral wrist joints and PIP joints even a few months after the disease onset. Laboratory tests showed CRP 8.95 mg/dl, FDP 14.0 μg/ml, and ferritin1 143 nm/ml. Rheumatoid factor, anti-CCP antibody or anti-nuclear antibody was negative. The patients’ disease was diagnosed as AOSD because his clinical manifestation fulfilled the diagnostic criteria proposed by Cush et al. He was treated successfully with prednisolone and Methotrexate. Recently, anti-cytokine therapy was reported to be introduced for AOSD; i.e. anti-interleukin (IL)-6 receptor antibody or anti-IL-1 antibody, and serum IL-6 level was increased in this patient.
    We discussed the early progression of arthritic joint destruction in the wrists in a patient with AOSD. We propose that early intervention of arthritis may be useful for such conditions.

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    Polymyalgia rheumatica (PMR) is a common disease in the elderly population. The diagnosis is based upon recognition of clinical symptoms, consisting of pain and stiffness in the shoulder and pelvic girdle, muscle tenderness of the upper and lower limbs and nonspecific somatic complaints. We are presenting two patients with PMR and severe dementia, who were not able to complain their symptoms. Patient1; an 84-year-old woman was referred to us for the bilateral swelling of hands and feet. She did not complain of any symptoms, however, her activities of daily living (ADL) had gradually decreased. A diagnosis of PMR was made by elevated ESR/CRP and the findings observed by nursery-home staff members. Treatment with 10 mg/day of prednisolone (PSL) was started with a dramatic response. Patient 2; an 80-year-old woman had repeated intermittent fever for six months. She was referred to us because her son wanted to know the cause of her fever. She did not complain of any pain and was not able to answer any questions. A diagnosis of PMR was made and PSL was started at 10 mg/day after the investigations of malignancy. In both patients, the observations by nursery-home staff members and family members were insufficient, but very important. Comprehensive geriatric assessment (GCA) is, which is a multidisciplinary evaluation for older people who have multiple problems, should be given greater emphasis, as a screening and follow-up tool.

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    The patient was an18-year-old female who first showed high CPK levels in August 2000 (when she was 12years old). Muscle biopsy confirmed dermatomyositis. Together with skin rash, she was diagnosed with juvenile dermatomyositis. She was treated with oral prednisolone (PSL) at a daily dose of 60 mg (≒2 mg/kg). Cyclosporine A (140 mg daily) was added for complicating interstitial pneumonia. However, her disease frequently relapsed when she had the common cold or other triggering factors. Various second-line treatments, such as intravenous immunoglobulin (IVIg) (45 g; 2 sessions), monthly IVCY (700 mg/body; 22 sessions), pulse methylprednisolone (1 g; 9 sessions), azathioprine (AZP, 50 mg daily), methotrexate (MTX, 16 mg weekly) and mycophenolate mofetil (3 g daily), were attempted for relapses. However, her flare never placed under good control. On the first visit to our clinic at the age of 18 years (February 2007), she showed a significantly increased level of serum CPK. Despite the combination of oral PSL (20 mg daily), AZP (150 mg daily) and MTX (16 mg weekly), her CPK reached8, 154 IU/L. Thus, AZP and MTX were substituted with tacrolimus (TAC), which had never been used, and pulse therapy with methylprednisolone (m-PSL) followed by oral m-PSL (48 mg daily). Her serum levels of myogenic enzymes were normalized after this treatment and no relapse has been observed for a year.
    Recently, there have been domestic and overseas studies describing the effectiveness of TAC on myositis. This is another case demonstrating the efficacy of the combination therapy of steroid hormone and TAC on dermatomyositis resistant to various immunosuppressants.

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    Behçet’s disease (BD) is a systemic disease presenting oral and genital ulceration, other skin lesions, uveitis and manifestations affecting the blood vessels. Among those, entero-Behçet’s disease is characterized by bowel inflammation with round and oval ulcers associated with gastro-entero-intestinal symptoms. BD is frequent in the Middle and Far East but is rare in the Europe and Western world, suggesting the contribution of a racial or genetic factor. Indeed, Human leukocyte antigen (HLA)-B 51 is a well-known genetic factor associated with BD.
    We report a case of a 25-year-old man with a 3-year history of entero-Behçet’s disease having surgical treatment three times after the disease onset. This patient was introduced to our hospital presenting with melena and lower abdominal pain, while he has been treated with prednisone, colchicine, mesalazine and infliximab for 3 years. Laboratory test results on admission were as follows; WBC 14000/ml, Hb 9.8 g/ml, CRP 0.55 mg/dl, AST 30 U/ml, ALT 75 U/ml, total protein 5.2 g/dl and albumin 2.6 g/dl. After entering our hospital, despite an additional treatment of neutrophil apheresis (G-CAP) for 5 times, he underwent surgery twice owing to massive hematochezia and sature-failure due to long-term steroid usage.
    The efficacy and indication of steroid, biologics, neutrophil apheresis and surgical therapy for entero-Behçet’s disease were discussed.

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