Correction: Baseline Serum Osteopontin Levels Predict the Clinical Effectiveness of Tocilizumab but Not Infliximab in Biologic-Naïve Patients with Rheumatoid Arthritis: A Single-Center Prospective Study at 1 Year (the Keio First-Bio Cohort Study)

<p>Correction: Baseline Serum Osteopontin Levels Predict the Clinical Effectiveness of Tocilizumab but Not Infliximab in Biologic-Naïve Patients with Rheumatoid Arthritis: A Single-Center Prospective Study at 1 Year (the Keio First-Bio Cohort Study)</p

Categorical changes in clinical indices.

<p>(A) Clinical Disease Activity Index (CDAI), (B) Simplified Disease Activity Index (SDAI), and (C) disease activity score with 28 joint counts, erythrocyte sedimentation rate (DAS28-ESR), over 1-year treatment of infliximab (IFX) or tocilizumab (TCZ). H, high disease activity; M, moderate disease activity; L, low disease activity; R, remission.</p

Predictive ability of osteopontin for clinical remission in patients with RA who received tocilizumab (TCZ) or infliximab (IFX).

<p>(A) Logistic regression analysis showing significant association of increasing baseline osteopontin (OPN) levels with decreasing predicted probability of achieving Clinical Disease Activity Index (CDAI) remission at 1 year in the TCZ (tocilizumab) group. (B) ROC curve showing a cut-off baseline OPN level of 17.3 ng/mL, discriminating between CDAI remission and non-remission at 1 year in the TCZ group, with a sensitivity of 66% and a specificity of 80%. (C) Logistic regression analysis showing no significant association of baseline OPN levels with predicted probability of achieving CDAI remission at 1 year in the IFX (infliximab) group. Categorical changes in clinical indices such as (D) CDAI, (E) Simplified Disease Activity Index (SDAI), and (F) disease activity score with 28 joint counts, erythrocyte sedimentation rate (DAS28-ESR) over 1-year treatment of TCZ or IFX, stratified by low or high baseline OPN levels (cut-off: 17.3 ng/mL). H, high disease activity; M, moderate disease activity; L, low disease activity; R, remission.</p

Efficacy and safety of tabalumab plus standard of care in Japanese patients with active systemic lupus erythematosus: Subgroup analyses of the ILLUMINATE-1 study

<p><i>Objective:</i> To assess the efficacy and safety of tabalumab, an anti-B cell activating factor (BAFF) antibody, in combination with standard of care (SoC) therapy in Japanese patients with active systemic lupus erythematosus (SLE).</p> <p><i>Methods:</i> A subgroup analysis was conducted in Japanese patients (<i>n</i> = 45) enrolled in ILLUMINATE-1, a phase III global trial in SLE patients (<i>N</i> = 1164). Patients received SoC plus tabalumab or placebo, starting with a loading dose (240 mg) at week 0, followed by 120 mg every 4 weeks (120 Q4W, <i>n</i> = 15), 120 mg every 2 weeks (120 Q2W, <i>n</i> = 15), or placebo Q2W (<i>n</i> = 15). The primary endpoint was proportion achieving SLE Responder Index-5 (SRI-5) improvement at week 52.</p> <p><i>Results:</i> A numerically greater SRI-5 response rate was achieved with 120 Q2W (46.7%; p = 0.059 vs. placebo) compared with 120 Q4W (20.0%) and placebo Q2W (13.3%). The proportion of patients with severe SLE flare was lower for 120 Q2W (0%) and 120 Q4W (6.7%) than for placebo (26.7%). The rates of serious adverse events (AEs) and treatment-emergent AEs were similar across treatments.</p> <p><i>Conclusion:</i> In Japanese SLE patients, tabalumab 120 Q2W improved SRI-5 response rate and reduced the frequency of severe flares compared with placebo. Safety profiles were similar with tabalumab and placebo.</p

Efficacy and safety of sirukumab in Japanese patients with moderate to severe rheumatoid arthritis inadequately controlled by disease modifying anti-rheumatic drugs: Subgroup analysis of a phase 3 study

<p><b>Objective:</b> To evaluate the efficacy and safety of sirukumab in Japanese patients with active rheumatoid arthritis (RA) uncontrolled by disease-modifying antirheumatic drugs.</p> <p><b>Methods:</b> This subgroup analysis based on a double-blind, placebo-controlled, 52-week phase 3 study (SIRROUND-D) assessed American College of Rheumatology (ACR) 20 response at week 16 and van der Heijde-modified Sharp score (vdH-S) at week 52 (coprimary endpoints).</p> <p><b>Results:</b> A total of 168 (Japanese)/1670 patients received sirukumab 50 mg/4 weeks (q4w, <i>n</i> = 58), 100 mg/every 2 weeks (q2w, <i>n</i> = 54), or placebo (<i>n</i> = 56) subcutaneously. Significantly more patients achieved ACR20 response at week 16 with sirukumab (50 mg q4w: 69.0%; 100mg q2w: 66.7%) vs. placebo (21.4%; <i>p</i> < .001). Median change from baseline in total vdH-S score at week 52 was significantly lower with sirukumab (50 mg q4w: 0.3, <i>p</i> = .024; 100 mg q2w: 0.0, <i>p</i> = .002) vs. placebo (1.3). Sirukumab consistently showed greater improvements in secondary endpoints at weeks 24 and 52. Nasopharyngitis, elevated liver enzymes, injection site erythema and upper respiratory tract infections were the common treatment-emergent adverse events (TEAEs). Incidences of TEAEs and serious AEs were consistent between sirukumab groups through week 52.</p> <p><b>Conclusion:</b> Sirukumab showed clinically meaningful improvements consistent with significant improvements in the global study. No new safety signals were observed.</p

Norsk Musik-Album

Erscheinungsjahr aus dem Pflichtexemplarsdatum der UB Graz ermittelt: X 1885Liedtexte norwegisch und englisch(VLID)220968

Additional file 1: Figure S1. of A new bioassay for measuring the strength of IL-6/STAT3 signal inhibition by tocilizumab in patients with rheumatoid arthritis

Transition in CDAI for each group of patients administered TCZ at different intervals. Transition in CDAI for the 3-week group (A), 4-week group (B) and 5-week group (C). TCZ tocilizumab, CDAI clinical disease activity index. (TIF 1404 kb

Efficacy and safety of sirukumab in Japanese patients with active rheumatoid arthritis who were refractory or intolerant to anti-tumor necrosis factor therapy: Subgroup analysis of a randomized, double-blind, multicenter, phase 3 study (SIRROUND-T)

<p><b>Objective:</b> To evaluate the efficacy and safety of sirukumab, a human anti-interleukin six monoclonal antibody, in Japanese patients with rheumatoid arthritis who were refractory to anti-tumor necrosis factor therapy.</p> <p><b>Methods:</b> This subgroup analysis, based on a double-blind, placebo-controlled, 52-week phase 3, global study (SIRROUND-T) assessed the American College of Rheumatology (ACR) 20 response at week 16 (primary endpoint). Secondary endpoints: ACR 50, Disease Activity Score in 28 joints-C reactive protein, Health Assessment Questionnaire-Disability Index and safety were assessed.</p> <p><b>Results</b> 116/878 patients received sirukumab 50 mg/4 weeks (q4w, <i>n</i> = 35), 100 mg/2 weeks (q2w, <i>n</i> = 44) or placebo (<i>n</i> = 37) subcutaneously. Significantly more patients achieved ACR 20 response at week 16 with sirukumab (50 mg q4w:20 [57.1%]; <i>p</i> < .001, 100 mg q2w:24 [54.5%]; <i>p</i> = .001) versus placebo (7 [18.9%]); consistent significant improvement in secondary endpoints at week 24 and 52 was observed. At week 24, incidence of treatment-emergent adverse events (TEAEs) was numerically higher with sirukumab groups (50 mg q4w:29 [82.9%]; 100 mg q2w:38 [86.4%] versus placebo (28 [75.7%]); however, at week 52, sirukumab combined groups had comparable incidence of TEAEs.</p> <p><b>Conclusion:</b> Efficacy findings through 52 weeks were comparable between sirukumab doses in Japanese patients and consistent with primary SIRROUND-T study results. No new safety signals were observed.</p

Safety and efficacy of CT-P13 in Japanese patients with rheumatoid arthritis in an extension phase or after switching from infliximab

<p><i>Objectives</i>: This study aimed to evaluate the safety of CT-P13 in patients with rheumatoid arthritis (RA) during long-term treatment or after switching from innovator infliximab (IFX).</p> <p><i>Methods</i>: Patients who completed 54 weeks of treatment in a phase I/II study (PI/II) received CT-P13 at an initial dose of 3 mg/kg at Week 62, with dose increases permitted up to 10 mg/kg. The primary endpoint was adverse event (AE) incidence.</p> <p><i>Results</i>: Thirty-four of 38 patients in the maintenance group and 29 of 33 in the switch group reported at least one AE. Safety profiles in both groups were similar to those in PI/II. Eleven of 28 patients who were positive for anti-drug antibodies (ADA) at Week 62 discontinued the study before Week 110. Forty-one of 43 ADA-negative patients remained negative, and 10 of 28 ADA-positive patients became negative during the study. The mean DAS28 (ESR) at Week 134 was 3.166 in the maintenance group and 3.955 in the switch group.</p> <p><i>Conclusions</i>: CT-P13 was well tolerated in patients who maintained the treatment after 54 weeks and in patients who switched to CT-P13 after 54 weeks of IFX treatment. The study also demonstrated a stable clinical efficacy of CT-P13 in RA patients.</p

Spearman's correlation coefficients and partial correlation coefficients of cartilage markers vesus RA disease markers.

*<p>Values are correlation coefficients calculated using Spearman's rank correlation. P values are expressed in parentheses. p<0.05 is considered as statistically significant.</p>**<p>Partial correlation coefficients were obtained after controlling CRP level for each marker pair.</p>¶<p>n.a., not applicable.</p>†<p>n.s., not significant.</p>‡<p>n.d., not determined.</p