Modern Rheumatology最新文献

Objectives: Systemic sclerosis is characterised by ischaemic skin ulcers on the fingertips, and low-energy shock wave therapy is suggested as a novel treatment for ischaemic lesions with angiogenic effects. We aimed to investigate the efficacy and safety of shock wave therapy for skin ulcers in patients with systemic sclerosis.

Methods: In this phase 3 pivotal study, we analysed 60 systemic sclerosis patients with digital ulcers that did not disappear after >4 weeks of existing treatment: 30 patients were treated with extracorporeal shock wave therapy and 30 with conventional treatment. The ulcer count reduction observed after an 8-week treatment period was compared between the shock wave therapy and conventional treatment groups.

Results: After an 8-week treatment period, the mean reduction in the number of ulcers was 0.83 (standard deviation [SD] 2.79) in the conventional treatment group compared to a more pronounced reduction of 4.47 (SD 2.65) in the shock wave therapy group.

Conclusions: The study findings indicate the efficacy of extracorporeal shock wave therapy for refractory digital ulcers associated with systemic sclerosis, which has limited therapeutic options. This therapy is non-invasive and safe and can be used without restriction in combination with other therapies, thus serving as a novel therapeutic method.

Objectives: We studied the current state and factors associated with the acceptance or hesitancy of booster doses of the coronavirus disease 2019 (COVID-19) vaccine among patients with autoimmune and rheumatic diseases (ARDs) in Japan.

Methods: A single-center cross-sectional survey was conducted among outpatients with ARDs who visited the Immuno-Rheumatology Center at St. Luke's International Hospital from 1 October to 30 November in 2023. We investigated patient characteristics, COVID-19 vaccination-related status, decision-making preferences, health-related status and independent factors associated with the acceptance or hesitancy of booster doses of the COVID-19 vaccine.

Results: A total of 241 patients were included in the analyses, and 198 patients (82.2%) received booster doses while 43 (17.8%) did not. Older age (adjusted odds ratio [aOR] = 0.43, 95% CI: 0.19, 0.95, P = 0.037), having rheumatoid arthritis (RA) (aOR = 0.41, 95% CI: 0.19, 0.92, P = 0.030) and having a physician recommend receiving the vaccine (aOR = 0.47, 95% CI: 0.23, 0.95, P = 0.035) were independently associated with receiving booster doses. The main reasons for hesitancy regarding booster doses were concerns about adverse reactions and long-term safety.

Conclusion: Our findings could help physicians counsel patients with ARDs regarding their acceptance of COVID-19 vaccine booster doses to promote appropriate decision-making.

Objectives: This study determined whether alkaline phosphatase can be used to distinguish giant cell arthritis complications in patients with polymyalgia rheumatica.

Methods: This retrospective study included patients diagnosed with polymyalgia rheumatica between January 2014 and October 2023 at our hospital. The predictive accuracy of biomarkers for diagnosing giant cell arthritis was evaluated. Logistic regression was performed to identify factors predicting giant cell arthritis complications.

Results: In total, 128 participants were included in this study and divided into two groups: isolated polymyalgia rheumatica (n = 111) and polymyalgia rheumatica with giant cell arthritis (n = 17). The median alkaline phosphatase level of polymyalgia rheumatica with giant cell arthritis group was significantly higher than that of the isolated polymyalgia rheumatica group (242.0 [interquartile range, 221.0-595.0] vs. 187.0 [interquartile range 97.5-254.5] U/L, P < 0.001). Setting a cut-off value of 214 U/L for alkaline phosphatase yielded a sensitivity and specificity of 0.88 and 0.55, respectively, for diagnosing giant cell arteritis. Multivariate analysis revealed that alkaline phosphatase was a significant independent variable in the complications of giant cell arteritis (odds ratio, 25.2; P = 0.032).

Conclusions: Alkaline phosphatase can help distinguish giant cell arthritis complications in patients with polymyalgia rheumatica.

Objectives: Some patients with sarcoidosis achieve spontaneous remission, whereas others repeatedly experience relapse. We examined differences in the clinical course of active sarcoidosis according to peripheral blood immunophenotypes before treatment.

Methods: This retrospective study compared peripheral blood immunophenotypes between patients with active sarcoidosis (n=28) and healthy control subjects (n=10). Patients with sarcoidosis were divided into the spontaneous remission group without treatment (n=9), the non-relapsed group after treatment (n=13), and the relapsed group after treatment (n=6) and were compared for peripheral blood immunophenotypes and background characteristics at baseline.

Results: Patients with sarcoidosis showed increases in activated T helper (Th) 1 cells, activated Th17 cells, and regulatory T (Treg) cell subsets. The proportion of effector Treg cells was highest in the spontaneous remission group, and the proportion of non-suppressive Treg cells was highest in the relapsed group. No differences were observed in the proportions of other CD4+ T cell subsets. The cut-off values for predicting spontaneous remission and relapse were calculated for the effector Treg/non-suppressive Treg ratio. As a result, A ratio ≥1.469 predicted spontaneous remission (75%), while ≤0.722 predicted relapse (66.7%).

Conclusion: Effector and non-suppressive Treg cell proportions before treatment may predict spontaneous remission and relapse in active sarcoidosis.

Objective: To evaluate immunoglobulin A vasculitis (IgAV) patients with gastrointestinal (GI) tract involvement and to reveal the relationship between the location and extent of the affected intestinal segment detected on the initial abdominal ultrasound (US) and GI tract bleeding.

Methods: This medical record review study was conducted on 117 IgAV patients with GI tract involvement between January 2016- June 2023. Patients were divided into two groups as those with (n=28) and without (n=89) GI tract bleeding. Predictors of GI tract bleeding were investigated by comparing demographic, clinical characteristics and laboratory findings.

Results: Gender, age at diagnosis, symptoms at admission, rash distribution, GI tract complaints, and the elapsed time until the development of GI tract symptoms were similar in both groups. There was no difference between small intestinal, large intestinal or small+large intestinal involvement (p=0.89). The ileum was the most commonly affected intestinal segment in patients with and without GI tract bleeding (p=0.37). Jejunal wall thickening (p=0.04) and the number of affected intestinal segments (p=0.008) were higher in patients with GI tract bleeding.

Conclusion: In IgAV patients, jejunum involvement and affected multiple intestinal segments shown by abdominal US are associated with GI tract bleeding.

Objectives: To describe safety and efficacy of filgotinib 200 or 100 mg (FIL200/FIL100) in Japanese patients with rheumatoid arthritis in a long-term extension (LTE; NCT03025308).

Methods: Patients who completed any of three parent studies (NCT02889796: inadequate response [IR] to methotrexate [MTX]; NCT02873936: IR to biologic disease-modifying antirheumatic drugs; NCT02886728: MTX-naïve) without rescue therapy could enter the LTE; patients taking FIL continued their dosage, and those who received comparators were rerandomised to FIL200 or FIL100. This analysis includes week 156 interim results.

Results: Among Japanese patients, 110 received FIL200, and 97 received FIL100. Mean (SD) FIL200 and FIL100 exposure was 157.0 (51.49) and 156.0 (52.45) weeks. The exposure-adjusted incidence rates (95% CI) for FIL200/FIL100 were 2.7 (1.4, 5.2)/2.4 (1.2, 5.1) for herpes zoster, 0.9 (0.3, 2.8)/1.0 (0.3, 3.2) for malignancy (excluding nonmelanoma skin cancer), and 0.6 (0.2, 2.4)/0.3 (0.0, 2.4) for major adverse cardiovascular events. More patients receiving FIL200 with prior FIL200 exposure achieved clinical remission vs other groups (including Clinical Disease Activity Index remission in 40% vs 27% or less at week 156).

Conclusions: FIL200 and FIL100 were generally well tolerated by Japanese patients, without new, unexpected adverse events.

Objectives: To provide long-term, real-world safety and effectiveness data for mepolizumab treatment in eosinophilic granulomatosis with polyangiitis in Japan.

Methods: MARS (NCT04551989) was a real-world, observational study of patients who had previously completed the PMS study (NCT03557060; ≥96 weeks of mepolizumab treatment before study entry [baseline]) and continued receiving four-weekly mepolizumab 300 mg subcutaneously for a further 96 weeks. Safety outcomes were assessed from baseline to Week 96 (observation period); clinical outcomes were assessed pre-mepolizumab initiation (retrospective period) and during the observation period.

Results: Of 118 patients enrolled in the study, 58% (69/118) experienced adverse events and 22% (26/118) experienced serious adverse events over the observation period; none were mepolizumab-related. Over the study (pre-mepolizumab period; baseline; end of observation period) the proportion of patients with no clinical symptoms increased (6%, to 27%, to 32%, respectively), median oral glucocorticoid dose decreased (6.9, to 3.0, to 2.0 mg/day, respectively) and the proportion of oral glucocorticoid-free patients increased (8%, to 31%, to 36%, respectively).

Conclusions: Long-term MARS study data are consistent with the known safety profile of mepolizumab. Over 192 weeks (pre-mepolizumab-observation), mepolizumab was well tolerated, with improvements in eosinophilic granulomatosis with polyangiitis disease control and reductions in oral glucocorticoid use.

Objective: To elucidate the therapeutic effect of orthopedic surgical intervention (OSI) in difficult-to-treat rheumatoid arthritis (D2T RA) compared with non-D2T RA.

Methods: A total of 534 recent surgeries were analyzed only in patients who had undergone OSI since 2016 and for whom a 12-month post-operative follow-up was available. D2T RA was determined according to the EULAR definition, and patients with D2T RA were matched to patients with non-D2T RA using propensity scores calculated by a logistic regression analysis. The Health Assessment Questionnaire-Disability Index (HAQ-DI), Disease Activity Index 28 (DAS28), face scale, and patient's assessment of general health (GH) were measured repeatedly at baseline and 6 and 12 months and were compared using a two-way analysis of variance.

Results: The HAQ-DI, DAS28, face scale, and GH showed significant post-operative improvements, and there were significant differences in the HAQ-DI and face scale scores between D2T RA and non-D2T RA. An additional analysis with DAS28 as a covariate showed no significant interaction for either, suggesting that these improvements in clinical assessment were due to OSI rather than improved disease activity.

Conclusions: In the absence of an effective pharmacological treatment strategy, OSI may be an effective treatment modality for the management of D2T RA.

Objectives: For the diagnosis of IgG4-related dacryoadenitis and sialadenitis, either revised comprehensive diagnostic criteria or organ-specific diagnostic criteria for IgG4-related dacryoadenitis and sialadenitis in 2008 were applied; however, the collected knowledge for IgG4-related dacryoadenitis and sialadenitis required us to revise the criteria for IgG4-related dacryoadenitis and sialadenitis.

Methods: The board member of Japanese Study Group for IgG4-related Dacryoadenitis and Sialadenitis revised the diagnostic criteria for IgG4-related dacryoadenitis and sialadenitis. We collected the clinical questions to be revised and performed a review of the literature. When the data were insufficient, additional data collection was performed. After the revision, public comments were collected.

Results: The three major points were revised. 1. Asymmetric or under two pairs of dacryoadenitis and sialoadenitis were included as IgG4-related dacryoadenitis and sialadenitis. 2. The thresholds of IgG4-positive cell infiltration were adjusted to an IgG4+/IgG+ ratio >0.4 and IgG4+ cells >10 per high power field. 3. The labial salivary gland biopsy was allowed to diagnose IgG4-related dacryoadenitis and sialadenitis.

Conclusions: The revised diagnostic criteria for IgG4-related dacryoadenitis and sialadenitis solved several issues with the previous criteria. It will improve the early diagnosis of IgG4-related dacryoadenitis and sialadenitis, especially in situations without enough resources for a biopsy.

Objectives: This study was conducted to investigate factors involved in anaphylaxis related to diclofenac etalhyaluronate (DEH) [product name: Joyclu® (JCL)] (containing DEH and macrogol 400), which is used to treat patients with osteoarthritis.

Methods: Patients with osteoarthritis were divided into two groups that had (experienced patients) or had not experienced anaphylactic symptoms after JCL administration (non-experienced patients). Five tests performed to assess factors related to anaphylaxis consisted of a skin prick test (SPT) as the primary endpoint and the other tests including basophil activation test, allergen-specific IgE (sIgE) tests using enzyme-linked immunosorbent assay or immunochromatographic kits, and genetic study were secondary endpoints.

Results: The SPT showed 4 (wheal)/7 (erythema) of 15 experienced patients and 0/3 of 19 non-experienced patients were positive for any of the test reagents containing DEH. The basophil activation test showed two experienced patients were positive for test reagents containing DEH. DEH- and diclofenac-sIgE were detected in 3 and 1 of 12 experienced patients, respectively. No clear results were shown in the other tests.

Conclusions: DEH may be the main factor involved in the development of anaphylaxis. The SPT was more sensitive than the basophil activation and allergen-sIgE tests for identifying factors associated with anaphylaxis.