Feasibility of methotrexate discontinuation following tocilizumab and methotrexate combination therapy in patients with long-standing and advanced rheumatoid arthritis: a 3-year observational cohort study.

OBJECTIVES: Methotrexate (MTX) is associated with extensive side effects, including myelosuppression, interstitial pneumonia, and infection. It is, therefore, critical to establish whether its administration is required after achieving remission with tocilizumab (TCZ) and MTX combination therapy in patients with rheumatoid arthritis (RA). Therefore, the aim of this multicenter, observational, cohort study was to evaluate the feasibility of MTX discontinuation for the safety of these patients. METHODS: Patients with RA were administered TCZ, with or without MTX, for 3 years; those who received TCZ+MTX combination therapy were selected. After remission was achieved, MTX was discontinued without flare development in one group (discontinued [DISC] group, n = 33) and continued without flare development in another group (maintain [MAIN] group, n = 37). The clinical efficacy of TCZ+MTX therapy, patient background characteristics, and adverse events were compared between groups. RESULTS: The disease activity score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR) at 3, 6, and 9 months was significantly lower in the DISC group (P < .05, P < .01, and P < .01, respectively). Further, the DAS28-ESR remission rate at 6 and 9 months and Boolean remission rate at 6 months were significantly higher in the DISC group (P < .01 for all). Disease duration was significantly longer in the DISC group (P < .05). Furthermore, the number of patients with stage 4 RA was significantly higher in the DISC group (P < .01). CONCLUSIONS: Once remission was achieved, MTX was discontinued in patients who responded favorably to TCZ+MTX therapy, despite the prolonged disease duration and stage progression.

Clinical characteristics of early-stage lumbar spondylolysis detected by magnetic resonance imaging in male adolescent baseball players.

BACKGROUND: Many adolescent athletes experience low back pain; the most common cause is lumbar spondylolysis. Although early identification of lumbar spondylolysis in adolescent athletes is critical, few studies have focused on identifying the early stages of spondylolysis in baseball players. This study aimed to investigate the clinical characteristics of early-stage spondylolysis in male adolescent baseball players. METHODS: The participants comprised male junior and high school baseball players. Before magnetic resonance imaging, we recorded their demographic data, low back pain characteristics, and physical findings (lumbar flexion, extension, Kemp's test and the provocative tenderness of a spinous process). After the imaging evaluation, the association among low back pain characteristics, physical findings and the final diagnosis (early-stage spondylolysis or not) were investigated using univariate and multivariable analyses. RESULTS: A total of 171 players were included in this study. Univariate analyses indicated that the characteristics associated with early-stage spondylolysis were longer duration of low back pain (P = 0.0085), low back pain-related interference while running (P = 0.0022), low back pain starting with laterality (P = 0.0001), lumbar extension (P = 0.022), positive Kemp's test (P = 0.020), and the tenderness of a spinous process (P = 0.0003). After adjusting for confounding factors (age and position), we found that early-stage spondylolysis was significantly associated with low back pain duration ≥4 weeks (odds ratio 3.13, 95% confidence interval 1.42-6.92; P = 0.0048), low back pain-related interference while running (odds ratio 2.89, 95% confidence interval 1.30-6.46; P = 0.0094), low back pain starting with laterality (odds ratio 2.78, 95% confidence interval 1.24-6.27; P = 0.0133), and the tenderness of a spinous process (odds ratio 3.00, 95% confidence interval 1.36-6.57; P = 0.0062). CONCLUSIONS: Male adolescent baseball players with early-stage spondylolysis might have low back pain duration of more than four weeks, low back pain-related interference while running, and a history of low back pain starting with laterality. The tenderness of a spinous process might be helpful in the diagnosis of early-stage spondylolysis in male adolescent baseball players.

Clinical and structural remission rates increased annually and radiographic progression was continuously inhibited during a 3-year administration of tocilizumab in patients with rheumatoid arthritis: A multi-center, prospective cohort study by the Michinoku Tocilizumab Study Group.

OBJECTIVE: To evaluate the clinical and structural efficacy of tocilizumab (TCZ) during its long-term administration in patients with rheumatoid arthritis (RA). METHODS: In total, 693 patients with RA who started TCZ therapy were followed for 3 years. Clinical efficacy was evaluated by DAS28-ESR and Boolean remission rates in 544 patients. Joint damage was assessed by calculating the modified total Sharp score (mTSS) in 50 patients. RESULTS: When the reason for discontinuation was limited to inadequate response or adverse events, the 1-, 2-, and 3-year continuation rates were 84.0%, 76.8%, and 72.2%, respectively. The mean DAS28-ESR was initially 5.1 and decreased to 2.5 at 6 months and to 2.2 at 36 months. The Boolean remission rate was initially 0.9% and increased to 21.7% at 6 months and to 32.2% at 36 months. The structural remission rates (ΔmTSS/year ≤ 0.5) were 68.8%, 78.6%, and 88.9% within the first, second, and third years, respectively. The structural remission rate at 3 years (ΔmTSS ≤ 1.5) was 66.0%, and earlier achievement of swollen joint count (SJC) of 1 or less resulted in better outcomes. CONCLUSIONS: TCZ was highly efficacious, and bone destruction was strongly prevented. SJC was an easy-to-use indicator of joint destruction.