Safety of baricitinib in Japanese patients with rheumatoid arthritis in clinical use: 3-year data of all-case post-marketing surveillance study.

OBJECTIVE: To assess safety of baricitinib in Japanese patients with rheumatoid arthritis in real-world clinical practice. METHODS: This all-case post-marketing surveillance study included patients initiating baricitinib for rheumatoid arthritis from September 2017 to April 2019. Treatment duration was recorded. Safety data were collected for up to 3 years from baricitinib initiation (up to 4 weeks post discontinuation in discontinuing patients). RESULTS: Safety analyses included 4720 patients; 2580 (54.7%) were ≥65 years old. Baricitinib persistence rate was 45.4% (3 year Kaplan-Meier analysis); the most common discontinuation reason was insufficient effectiveness (n = 1005, 21.3%). Serious adverse events occurred in 600 patients (incidence rate 10.42/100 patient-years; 95% confidence interval, 9.76-11.09). There were 39 deaths (incidence rate 0.43 [0.30-0.57]/100 patient-years). Incidence rate per 100 patient-years for adverse events of special interest were herpes zoster 4.68 (4.22-5.14), serious infection 3.05 (2.68-3.41), malignancy 1.09 (0.87-1.30), major adverse cardiovascular events 0.35 (0.23-0.48) and venous thromboembolism 0.25 (0.15-0.36). Incidence rates did not increase with prolonged exposure. CONCLUSIONS: No new safety concerns were identified during this 3 year post-marketing surveillance study of baricitinib in Japanese patients with rheumatoid arthritis. Patients and clinicians should be cognizant of herpes zoster and other serious infection risks during baricitinib treatment, especially in the first 6 months.

Quantitative Measurement of Rotation in Phalangeal Fracture Malunion Using Computed Tomography Imaging-"Linkage Simulation".

Malunion of thumb and finger fractures causes problems in the cosmetic and functional aspects of the hand. Malunion of phalangeal fractures usually manifests as a combination of rotational deformities in the coronal, sagittal, and transverse planes, and corrective osteotomy is performed on the planes that cause these problems. Quantification of the deformity is essential for precise osteotomy and is difficult to perform in the transverse plane, even with radiography or computed tomography. Thus, we developed a technique called linkage simulation for the quantitative measurement of rotational deformities for surgical planning. In this procedure, finger extension and flexion can be simulated based on the predicted rotational axis of the joint, which is useful for determining the appropriate correction. Furthermore, by performing a reduction simulation in the software, it is possible to simulate the surgery and predict the postoperative results. This paper reports the details of this technique.

Surgical treatment of fragility fractures of the pelvis: short-term outcomes of 42 patients.

PURPOSE: The present retrospective study aimed to analyze patient characteristics, perioperative complications, and short-term outcomes of surgery for fragility fractures of the pelvis (FFP). METHODS: We selected 42 patients who underwent surgery for FFP between October 2019 and October 2022 and could be followed for more than 6 months postoperatively, including one male patient and 41 female patients with an average age of 83.5 (65-96) years. The following demographic data were collected: Rommens classification, surgical method, reoperation rate, implant loosening, perioperative complications, interventional radiology (IVR) indication rate, perioperative blood transfusion indication rate, Parker Mobility Score (PMS) before surgery and at final follow-up, and numerical rating scale (NRS) score before surgery and on day 3 postoperatively. RESULTS: Rommens classification was as follows: type IIa (n = 2), type IIb (n = 13), type IIIa (n = 8), type IIIc (n = 3), type IVb (n = 13), and type IVc (n = 3). For surgical procedure, 35 patients (83.3%) were successfully stabilized with percutaneous screw fixation alone, and 7 patients further required open plate fixation. Implant loosening was observed in 16 patients (38.1%), including minor cases, and implant removal was required in 1 patient. Minor perforation of the screw was observed as an intraoperative complication in 6 patients; there were no patients with neurological symptoms. At the time of injury, IVR was indicated in 3 patients (7.1%) because of hemorrhage. Thirty patients (71.4%) had medical complications at the time of admission. One patient died due to postoperative pneumonia. Mean PMS before injury and at final follow-up were 6.51 points and 5.38 points, respectively. Mean NRS scores before surgery and on day 3 postoperatively were 5.26 and 3.49, respectively, showing a significant improvement (p < 0.01). CONCLUSION: We retrospectively reviewed 42 patients who required surgery for FFP. More than 80% of cases could be treated with percutaneous screw fixation, but it is always important to consider hemorrhagic shock at the time of injury and indications for IVR. Implant loosening was observed in 38.1% of patients, including minor cases, and was considered an issue to be improved on in the future, such as by using cement augmentation. A significant improvement in mean NRS score on day 3 postoperatively relative to the mean preoperative score was observed, suggesting that surgery may contribute to early mobilization.

Factors associated with discrepancies in disease activity as assessed by SDAI and RAPID3 in patients with rheumatoid arthritis: Data from a multicenter observational study (T-FLAG).

OBJECTIVES: The present study aimed to examine discrepancies between assessments based on Routine Assessment of Patient Index Data 3 (RAPID3) and Simple Disease Activity Index (SDAI) in RA patients with controlled disease activity. METHODS: Data from 464 RA patients in SDAI remission or low disease activity (REM/LDA) were analyzed. Patient-reported outcome (PRO) measures, including Health Assessment Questionnaire Disability Index (HAQ-DI), 25-question Geriatric Locomotive Function Scale (GLFS-25), and Kihon checklist (KCL), were assessed. Logistic regression models were used to identify factors associated with RAPID3 moderate or high disease activity (MDA/HDA). Cutoff values of RAPID3 MDA/HDA for each PRO evaluation item were determined using receiver operating characteristic curve analysis. RESULTS: Among RA patients in SDAI REM/LDA, 84.9% were in RAPID3 REM/LDA. Multivariable analysis revealed that HAQ-DI, GLFS-25, and KCL were independently associated with RAPID3 MDA/HDA. Subdomain analysis of KCL revealed that activities of daily living, physical function, cognitive function, and depressive mood were significantly associated with RAPID3 MDA/HDA. Cutoff values for HAQ-DI and KCL were 0.38 and 8, respectively. CONCLUSIONS: In RA patients with controlled disease activity, discrepancies between RAPID3 and SDAI assessments were observed, with factors such as HAQ-DI, GLFS-25, and KCL being independently associated with RAPID3 MDA/HDA.

Well-controlled disease activity with drug treatment will not improve the frailty status of RA patients to robust state: A multicenter observational study (T-FLAG).

OBJECTIVES: To investigate a plateau in treatment enhancement for improving the frailty status of rheumatoid arthritis (RA) patients. METHODS: A total of 345 RA patients who were not robust in 2021 were assigned to the improved ("robust 2022," n = 51) and non-improved ("pre-frailty/frailty 2022," n = 294) groups. Factors associated with "robust 2022" were examined by logistic regression analysis. Patients were assigned to the stable (Follow-up mean DAS28-ESR in 2020 and 2021 < 3.2, n = 225) and unstable (≥3.2, n = 120) groups, which were further divided into the non-improved (stable: n = 180, unstable: n = 114) and improved (stable: n = 45, unstable: n = 6) groups. Factors influencing Japanese Cardiovascular Health Study (J-CHS) score were examined by multiple regression analysis. Changes over 2 years were compared between the non-improved and improved groups of the stable group. RESULTS: The associated factor of "robust 2022" was the follow-up meanDAS28-ESR in 2020 and 2021 < 3.2 (i.e., stable state) (OR: 4.01). Follow-up mean DAS28-ESR in 2020 and 2021 was associated with J-CHS score (T = 2.536, p = .013) only in the unstable group. In the stable group, HAQ-DI was lower (2020: 0.32 vs. 0.16; 2021: 0.32 vs. 0.17; 2022: 0.32 vs. 0.21), and the proportion of J-CHS: Q4 (weakness) was lower (2020: 48.4 vs. 17.8%; 2021: 55.0 vs. 29.2%; 2022: 50.4 vs. 0%), in the improved group than in the non-improved group, whereas both groups maintained clinical and functional remission over 2 years. CONCLUSIONS: Drug treatment to maintain well-controlled disease activity alone is insufficient for improving patients' frailty status after achieving treat-to-target goals, suggesting the need for multifaceted approaches.

Associations of frailty with RA-ILD and poor control of disease activity in patients with rheumatoid arthritis: A multi-center retrospective observational study.

BACKGROUND: This study aimed to investigate factors associated with frailty in rheumatoid arthritis (RA) patients. METHODS: A total of 656 RA patients were evaluated using data from an observational study in 2022. Among these patients, 152 with frailty were assigned to the frailty group, and 504 without frailty were assigned to the non-frailty group. Patient characteristics were compared between the two groups by univariate analysis, and factors associated with frailty were assessed by logistic regression analysis. Patient characteristics were also compared between patients with RA-associated interstitial lung disease (RA-ILD) (n = 102) and those without RA-ILD (n = 554). RESULTS: The frailty group was older (mean: 73.6 vs. 66.8 years) and had a higher DAS28-ESR (3.67 vs. 2.66), a higher HAQ-DI (1.13 vs. 0.32), and a higher rate of RA-ILD (25.0 vs. 12.7 %) than the non-frailty group. Age (OR: 1.03, 95 % CI: 1.01-1.05), HAQ-DI (3.22, 2.28-4.56), DAS28-ESR (1.44, 1.19-1.75), and RA-ILD (2.21, 1.24-3.94) were associated with frailty. RA patients with RA-ILD were older (73.3 vs. 67.5 years) and had a higher DAS28-ESR (3.30 vs. 2.80), a higher HAQ-DI (1.19 vs. 0.32), a higher proportion of frail patients (37.3 vs. 20.6 %), lower MTX use (26.5 vs. 62.9 %), and higher steroid use (44.1 vs. 26.8 %) than those without RA-ILD. CONCLUSIONS: Maintaining reasonable control of disease activity is necessary for RA patients, including those with RA-ILD, to recover from frailty.

Associations between Degenerative Lumbar Scoliosis Structures and Pain Distribution in Adults with Chronic Low Back Pain.

BACKGROUND: This study aimed to investigate the location and distribution of pain in adults with chronic low back pain (LBP) with degenerative lumbar scoliosis (DLS) according to coronal deformities. METHODS: We enrolled 100 adults with chronic LBP and DLS, dividing them into two groups, a right-convex DLS group (n = 50) and a left-convex DLS group (n = 50). Dominant pain location was analyzed by dividing it into three parts-left side, right side, and center-and pain areas were identified using the pain drawing method; then, a heat map was created for each group. An association between pain location and convex side was analyzed as the primary outcome. Additionally, we assessed pain characteristics and radiological parameters, such as the curve structure and degree of degeneration. We used the Mann-Whitney U test or the chi-squared test to compare the clinical characteristics of the two groups, and generalized linear models were utilized to determine which variables were associated with pain severity or pain area. RESULTS: The results indicated that there was no significant difference between the two groups in terms of the association between the curve structure, pain severity and location. In multivariate analysis, although we did not find any variables associated with pain severity, we observed that age and a left-convex DLS were negatively correlated with pain area among all participants. The heat map demonstrated that individuals with chronic LBP frequently experienced pain in the central lumbar region, regardless of the coronal curve structure. CONCLUSIONS: Our findings suggest that degenerative coronal lumbar deformities may not have a specific pain pattern associated with a curved structure.

Choice of and response to treatment in patients with early-diagnosed rheumatoid arthritis: Real-world data from an inception cohort in Japan (NICER-J).

OBJECTIVE: Various guidelines recommend that patients with early rheumatoid arthritis (RA) try to achieve clinical remission within 6 months, and early therapeutic intervention is important to this end. This study aimed to investigate short-term treatment outcomes of patients with early-diagnosed RA in clinical practice and to examine predictive factors for achieving remission. METHODS: Of the 210 patients enrolled in the multicenter RA inception cohort, 172 patients who were followed up to 6 months after treatment initiation (baseline) were included. Logistic regression analysis was used to examine the impact of baseline characteristics on achievement of Boolean remission at 6 months. RESULTS: Participants (mean age, 62 years) initiated treatment after a mean of 19 days from RA diagnosis. At baseline and 3 and 6 months after treatment initiation, proportions of patients using methotrexate (MTX) were 87.8%, 89.0%, and 88.3%, respectively, and rates of Boolean remission were 1.8%, 27.8%, and 34.5%, respectively. Multivariate analysis revealed that physician global assessment (PhGA) (Odds ratio (OR): 0.84, 95% confidence interval (CI): 0.71-0.99) and glucocorticoid use (OR: 0.26, 95% CI: 0.10-0.65) at baseline were independent factors that predicted Boolean remission at 6 months. CONCLUSION: After a diagnosis of RA, satisfactory therapeutic effects were achieved at 6 months after the initiation of treatment centered on MTX according to the treat to target strategy. PhGA and glucocorticoid use at treatment initiation are useful for predicting the achievement of treatment goals.

Usefulness of the FilmArray blood culture identification panel for identifying causative pathogens of bone and joint infections.

As bone and joint infections (BJIs) require long-term treatment, identifying their causative pathogens is vital. However, the detection rate of conventional culturing remains inadequate. This study aimed to evaluate the usefulness of the FilmArray blood culture identification (BCID) panel for identifying causative pathogens in patients with BJIs. We tested a BCID panel using collected samples, in addition to conventional cultures. The primary outcome was to evaluate the diagnostic performance of the BCID panel, calculated using conventional culturing methods. A total of 44 patients who underwent BJI-related specimen collection were enrolled. Of the 44 patients, 22 were diagnosed with a BJI. Conventional culture identified 15 of 22 organisms (68.2%), whereas the BCID panel identified 14 of 22 organisms (63.4%). The overall sensitivity and specificity of the BCID panel were 73.3% and 57.1%, respectively, compared to those of the conventional culture. However, the sensitivity reached 100% when only pathogens included in the BCID panel were considered. In seven culture-negative cases, the BCID panel identified three organisms (42.9%). The BCID panel also indicated the appropriate therapy against a BJI caused by methicillin-resistant Staphylococcus aureus by detecting the mecA gene. This study demonstrated that the BCID panel has the potential for early and accurate diagnosis of the causative organism of BJI using specimens such as joint fluid and bone tissue. Our results suggest that BCID panels, in addition to routine culture, may improve our ability to diagnose the causative microorganisms of BJI in clinical practice, thereby contributing to the selection of appropriate antimicrobial agents.

Patient-Specific Femoral Guide with 3-Dimensional Support Software in Anterolateral Supine Approach of Total Hip Arthroplasty: A Single-Arm Trial.

Currently, there is no surgical assistance system that can perform a three-dimensional (3D) planned total hip arthroplasty (THA) by methods other than surgical assistance navigation or robots. However, they are expensive, cumbersome, and subject to additional invasiveness, so there is a need for a simpler and less expensive 3D surgical support system. In this study, THA was performed using the anterolateral approach (Watson-Jones) in the supine position in 23 subjects to examine the efficacy and safety of a patient-specific femoral guide linked to 3D surgery support software. In 48% of the subjects, the difference in anterior torsion angle from the preoperative plan was within ±5 degrees, while in 83% of the subjects, the difference was within ±10 degrees. The 95% confidence interval (4.61-8.70) of the absolute difference did not fall below the pre-defined threshold of 7.2 degrees (p = 0.293). No adverse events were observed other than 2 cases (8.7%) of hemorrhage that required a blood transfusion. We confirmed the efficacy and safety of the patient-specific femoral guide in anterolateral supine approach THA.

Periprosthetic humeral fracture revision using a massive allograft in a patient with rheumatoid arthritis: A case report.

Total elbow arthroplasty (TEA) is a surgical option for patients with rheumatoid arthritis (RA). Periprosthetic fractures during and after TEA are one of the most common causes of reoperation. Fractures around the stem of a loose prosthesis with associated bone loss are the most technically challenging to treat. Previous reports have demonstrated that the use of massive allografts is a reasonable alternative in salvage situations. Here, we report the case of a 78-year-old woman with RA who underwent revision TEA using massive allografts with modifications to the methods described in previous reports. She suffered a right periprosthetic humeral fracture 5 years after primary TEA, with a fracture in the proximal humeral diaphysis and a long spiral fracture in the diaphysis. The fracture around the stem of a loose prosthesis was associated with bone loss. We performed revision TEA using an allograft of the proximal femoral diaphysis. In contrast to previous reports, we preserved part of the humeral diaphysis, which was thin due to osteolysis, without removal. The advantage of this approach was that it preserved attachments, such as the deltoid and brachioradialis muscles. The patient had good elbow function and minimal pain without adverse events at 1 year postoperatively. Our findings suggest that preserving part of a thinned humeral diaphysis is a reasonable option in revision TEA with a massive composite allograft.

Factors associated with frailty in rheumatoid arthritis patients with decreased renal function.

OBJECTIVES: To investigate factors associated with frailty in rheumatoid arthritis (RA) patients with decreased renal function. METHODS: RA patients who visited outpatient clinics from June to August 2021 were included (N = 625). Patients with estimated glomerular filtration rate <60 ml/min/1.73 m2 were defined as having decreased renal function (N = 221) and divided into the non-frailty (N = 153) and frailty (N = 58) groups. Patient characteristics were compared between the two groups by univariate analysis. Significant factors in univariate analysis were assessed by logistic regression analysis to determine their association with frailty in patients with decreased renal function. RESULTS: Patients in the frailty group were older (74.0 vs.79.0 years) and had a longer duration of disease (11.1 vs. 17.8 years), higher Disease Activity Score erythrocyte sedimentation rate (DAS28-ESR; 2.99 vs. 3.80), higher Health Assessment Questionnaire Disability Index (0.42 vs. 1.43), and a lower rate of methotrexate (MTX) use (46.4% vs. 25.9) compared to those in the non-frailty group. Factors associated with frailty in patients with decreased renal function were age (odds ratio: 1.07), duration of disease (1.06), DAS28-ESR (1.85), and MTX use (0.42). CONCLUSIONS: Among factors associated with frailty in RA patients with decreased renal function, improving DAS28-ESR is likely to be the most feasible approach to promote recovery from frailty (200/200 words).

Predictive factors for achievement of treatment goals in patients with postmenopausal osteoporosis treated with denosumab.

OBJECTIVES: To investigate efficacy of long-term treatment with denosumab and predictive factors for achievement of treatment goals in patients with postmenopausal osteoporosis (PMO). METHODS: We enrolled 111 PMO patients who had T-scores ≤-2.5 either at the lumbar spine (L-) or femoral neck (FN-), who had never been treated for osteoporosis, and who could be followed for at least 3 years. We first evaluated changes in bone mineral density (BMD) for up to 7 years. We next defined the treatment goal as the achievement of a T-score >-2.5 at month 36 and performed multivariate analysis to identify predictive factors for achievement of the goal. RESULTS: Lumbar spine- and femoral neck bone-mineral density increased yearly for 7 years. Among 87 patients with baseline L-T-scores ≤-2.5, better baseline L-T-scores predicted achievement of L-T-scores >-2.5 at month 36. The cut-off value for baseline L-T-score was -3.4. Among 76 patients with baseline FN-T-scores ≤-2.5, better baseline FN-T-scores predicted achievement of FN-T-scores >-2.5 at month 36. The cut-off value for baseline FN-T-scores was -2.8. CONCLUSIONS: Long-term treatment with denosumab was effective in PMO patients. As better baseline T-score predicted achievement of T-scores >-2.5, early initiation of treatment will contribute to better outcome.

Increased prevalence of Staphylococcus aureus nasal carriage in rheumatoid arthritis patients with moderate/high disease activity.

BACKGROUND: Staphylococcus aureus (S. aureus) nasal carriage is a well-known risk factor for surgical site infection (SSI) after total joint arthroplasty. This study aimed to compare the prevalence of S. aureus nasal carriage between patients with osteoarthritis (OA), a degenerative joint disease, and those with rheumatoid arthritis (RA), a chronic autoimmune inflammatory disease, who underwent total joint arthroplasty, and to investigate the influence of RA disease activity on nasal carriage rate. METHODS: This retrospective study targeted 508 OA and 107 RA patients who underwent S. aureus nasal screening prior to primary total knee and/or hip arthroplasty. RA patients were divided into two groups based on disease activity: the remission/low disease activity (REM/LDA) group and the moderate/high disease activity (MDA/HDA) group. Factors associated with S. aureus nasal carriage were assessed with multivariate logistic regression models. RESULTS: Of all 615 patients, 155 (25%) carried S. aureus in their nares. Compared to OA patients, RA patients had a significantly higher rate of S. aureus nasal carriage (24% vs. 33%, p = 0.049). Compared to the REM/LDA group (n = 39), the MDA/HDA group (n = 58) had a significantly higher rate of S. aureus nasal carriage (21% vs. 41%, p = 0.032). Multivariate analysis revealed that the MDA/HDA group, but not the REM/LDA group, had a significantly higher odds of S. aureus nasal carriage compared to the OA group (odds ratio: 2.76, 95% confidence interval: 1.07-7.12). CONCLUSION: Preoperative nasal screening for S. aureus is beneficial, especially in RA patients with moderate/high disease activity.

Effectiveness of tacrolimus concomitant with biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis.

OBJECTIVES: The study aimed to investigate the effectiveness and tolerance of biological disease-modifying antirheumatic drugs (bDMARDs) therapy administered concomitantly with tacrolimus (TAC) treatment in patients with rheumatoid arthritis. METHODS: 2792 patients who underwent therapy with five bDMARDs (etanercept: ETN, adalimumab, golimumab, tocilizumab, and abatacept: ABT) were enrolled. Among the study subjects, 1582 were concomitant methotrexate (MTX group), 147 were concomitant TAC (TAC group), and 1063 were non-concomitant MTX and TAC (non-MTX/TAC group). The primary outcome was the incident rate of discontinuation of bDMARDs by adverse events (AEs) or loss of efficacy. RESULTS: Concerning the analysis for each reasons of discontinuation, including AEs and loss of efficacy, the hazards ratio (HR) was significantly lower in the TAC group than in non-MTX/TAC groups (AEs: HR = 0.39, 95% confidence interval, 0.23-0.68, loss of efficacy: HR = 0.49, 95% confidence interval, 0.30-0.78). The loss of efficacy with the use of ETN and ABT was lower in the TAC group than in non-MTX/TAC groups. Concomitant TAC did not induce elevated risk for discontinuation of AEs in all bDMARD analyses. CONCLUSIONS: Concomitant TAC with ABT or ETN showed higher retention rates than bDMARDs therapy without TAC or MTX. AEs did not increase over long-term observation.

A case of synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome with isolated lesions of the thoracic spine.

We report a case of isolated lesions of the thoracic spine attributed to synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome. A 55-year-old woman who suffered from 6 months of back pain had vertebral osteomyelitis on magnetic resonance imaging (MRI). There were no laboratory findings suggestive of infection, malignancy, or autoimmune disease. Radiography, computed tomography (CT), and MRI of the thoracic spine showed mixed lesions of sclerosis and erosion, whereas bone scintigraphy did not show accumulation at any site except the thoracic spine. No lesions in the anterior chest wall or sacroiliac joints were apparent from CT and MRI. No lesions other than at the thoracic spine were observed. As the isolated lesions of the thoracic spine were considered not to have resulted from infection, malignancy, or autoimmune disease, the patient was referred to our department for differential diagnosis. Given that isolated sterile hyperostosis/osteitis among adults is included in the modified diagnostic criteria for SAPHO syndrome, we suspected that the mixed lesions of sclerosis and erosion of the thoracic spine in this case may reflect SAPHO syndrome with chronic non-bacterial osteitis (CNO) of the thoracic spine. Treatment with non-steroidal anti-inflammatory drugs (NSAIDs) was initiated and led to alleviation of her back pain, although the thoracic spine lesions remained on the 6-month MRI. Based on the CNO of the thoracic spine and the rapid response to NSAIDs, the final diagnosis was SAPHO syndrome with isolated lesions of the thoracic spine.

Risk factors for denosumab discontinuation in patients with postmenopausal osteoporosis.

OBJECTIVES: Persistence with treatment is key to achieving successful treatment outcomes in patients with osteoporosis. We investigated risk factors for denosumab discontinuation in patients with postmenopausal osteoporosis (PMO). METHODS: A total of 333 patients with PMO who had never received osteoporosis treatment were included in this study. Baseline demographics and retention rate of denosumab were evaluated in all patients. Univariate analysis was performed in patients divided into two groups according to whether they had continued or discontinued denosumab. A Cox proportional hazards model was used to determine risk factors for denosumab discontinuation. RESULTS: The mean age was 80.7 years, the body mass index (BMI) was 21.5 kg/m2, and T-scores for the lumbar spine and femoral neck were -2.7 and -2.8, respectively. The retention rate of denosumab at 36 months was 50.3%. Patients who continued denosumab were younger and had higher BMI, serum albumin (Alb) levels, lumbar spine bone mineral density, and fewer vertebral fractures (VFs), compared with those who discontinued denosumab. The Cox proportional hazards model revealed that a low BMI, low serum Alb levels, and a high number of VFs are independent risk factors for denosumab discontinuation. CONCLUSIONS: A low BMI, low serum Alb levels, and a high number of VFs were associated with denosumab discontinuation in patients with PMO.

Age and symptoms at onset of ankylosing spondylitis in Japanese patients.

OBJECTIVES: To examine the age at onset and initial symptoms as clinical features of ankylosing spondylitis in Japanese patients. METHODS: This retrospective study included 60 Japanese patients diagnosed with ankylosing spondylitis at our institute between January 2004 and June 2021. Initial symptoms were considered pain in axial joints and/or extra-axial joints. If a patient had initial symptoms at multiple sites, each site was counted. We assessed trends for the number of patients and sites of initial symptoms according to age at onset. RESULTS: Mean age (± standard deviation) at onset was 28.9 (± 14.3) years. Approximately one-third of patients experienced onset before age 20. The back was the most common site of initial symptoms (36.7%), followed by the hip (26.7%), knee (15%), buttocks (15%), neck (10%), finger (6.7%), shoulder (3.3%), and others (including overlapping sites). Thirty-two (53.3%) and 25 (41.7%) patients had initial symptoms only in axial joints and only in extra-axial joints, respectively. The proportion of patients with initial symptoms only in extra-axial joints significantly decreased with increasing age (p = .024). CONCLUSIONS: Sites of initial symptoms were frequently the back, hip, knee, and buttocks, and 41.7% had initial symptoms only in extra-axial joints. Younger onset patients frequently had extra-axial involvement.

Safety and effectiveness of baricitinib for rheumatoid arthritis in Japanese clinical practice: 24-week results of all-case post-marketing surveillance.

OBJECTIVES: To assess the safety and effectiveness of baricitinib treatment for rheumatoid arthritis (RA) in real-world clinical practice. METHODS: This ongoing all-case post-marketing surveillance study (starting September 2017) includes all patients with RA treated with baricitinib in Japan. Safety and effectiveness (disease activity) were assessed for 24 weeks. RESULTS: Safety analyses to February 2021 included 4731 patients (initial baricitinib dose: 4 mg/day, n = 3058; 2 mg/day, n = 1661; other, n = 12); 1059 (22.38%) were ≥75 years and 3362 (71.06%) previously received biologic therapy. The overall observational period was 1863.14 patient-years; 1174 (24.82%) patients discontinued baricitinib before Week 24, mostly for lack of effectiveness (n = 478; 10.10%). Adverse events occurred in 1271 (26.87%) patients [serious: 203 (4.29%); death: 18 (0.38%)]. The incidence of herpes zoster, hepatic function disorder, and serious infection was 3.09%, 2.77%, and 1.90%, respectively. Malignancy occurred in 17 patients (0.36%) and major adverse cardiovascular events in seven patients (0.15%). Among patients with effectiveness data, at least 26.57% (Boolean) achieved remission at Week 24. CONCLUSIONS: This large nationwide surveillance study evaluated the safety and effectiveness of 24 weeks of baricitinib for RA in real-world clinical practice. Continued surveillance of long-term safety is ongoing.

Reasons and risk factors for discontinuation of treatment with any biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis: A long-term observational study.

OBJECTIVES: Patients with rheumatoid arthritis (RA) usually switch to a second biological disease-modifying antirheumatic drugs (bDMARDs) when the first has proven to be ineffective, although some may discontinue bDMARDs treatment altogether. We investigated the total rate of bDMARDs retention and the risk of bDMARDs discontinuation in patients with RA. METHODS: The study included 564 patients with RA who started bDMARDs treatment before 2008 (<65 years old, n = 413; ≥65, n = 151). The primary outcome was the incidence of bDMARDs discontinuation due to adverse events (AEs). Risk factors were examined using Fine and Gray regression models. RESULTS: Among 564 patients, 74 had discontinued bDMARDs treatment due to AEs. Male sex and Steinbrocker class 3-4 were more frequent, while rheumatoid factor and concomitant methotrexate treatment were less frequent, in those aged ≥65 years than in those aged <65 years, respectively. The subdistribution hazard ratio for discontinuation was significantly higher in the ≥65 group than in the <65 years group (hazard ratio = 3.53, 95% confidence interval = 2.07-6.03). Lack of concomitant treatment with MTX was risk factor for discontinuation in patients ≥65 years. Advanced Steinbrocker class was a risk factor in patients <65 years. CONCLUSIONS: Older patients are at higher risk of discontinuing bDMARDs treatment due to AEs than younger patients.