[The efficacy and safety of tocilizumab combined with disease-modifying anti-rheumatoid drugs in the treatment of active rheumatoid arthritis: a multi-center, randomized, double-blinded, placebo-controlled trial].

OBJECTIVE: To evaluate the efficacy and safety of human anti-interleukin-6 (IL-6) receptor antibody (tocilizumab) in combination with disease-modifying anti-rheumatoid drugs (DMARDs) for the treatment of rheumatoid arthritis (RA) patients with moderate to severe activity and inadequate response to DMARDs. METHODS: The present study was a multi-center, randomized, double-blinded, placebo controlled trial. Eligible patients were randomized (tocilizumab:Placebo = 2:1) to one of two groups: tocilizumab 8 mg/kg group or placebo group. The drug was administered every 4 weeks by infusion along with stable dose of DMARDs. The primary analysis evaluated at week 24 included: the proportion of patients with American College of Rheumatology (ACR)20, ACR50 and ACR70 response; the average changes of ACR core components from baseline; the proportion of patients with disease activity score (DAS28) ≤ 3.2 and DAS28 < 2.6. Patients who completed double-blinded phase could choose to enter 24-week open-label therapy with tocilizumab 8 mg/kg infusion every 4 weeks. RESULTS: Totally 139 patients from tocilizumab group and 69 patients from placebo group completed the 24-week double-blinded period respectively with comparable baseline characteristics. The proportion of patients with ACR20, ACR50 and ACR70 in tocilizumab group was significantly higher than that in placebo group: 69.8% vs 24.6% (P < 0.05), 38.8% vs 10.1% (P < 0.05) and 12.9% vs 2.9% (P < 0.05) respectively. ACR core components change, proportion of patients with DAS28 ≤ 3.2 and DAS28 < 2.6 were all better in tocilizumab group than those in the placebo group. Decreased level of biomarkers C-terminal crosslinking telopeptide of type I collagen generated by matrix metalloproteinases (ICTP), matrix metalloproteinase 3 (MMP-3) and N-terminal propeptide of type IIA collagen (PIIANP) were observed in patients with tocilizumab treatment, indicating its positive effects on bone metabolism. A total of 202 patients received tocilizumab treatment in the study with the longest duration as 48 weeks, and all the indexes were improved further with the elongation of the treatment time. During the doubled blind phase, 42.4% of patients in the tocilizumab group had ≥ 1 adverse event (AE), compared with 27.9% of patients in the control group. The most common AE was infection, and most of the AEs were mild to moderate. Serious AEs occurred in 0.7% and 5.9% of patients in the tocilizumab and control groups, respectively. More patients in the tocilizumab group had higher percentage of increased alanine transaminase and aspartate transaminase (12.9% and 9.4%) compared to the placebo group (4.4% and 4.4%). Increase of total cholesterol, high density lipoprotein, low density lipoprotein, and triacylglycerol were observed in the tocilizumab group, but no increase of occurrence of cardiac events. No additional safety signals were found during the extension phase. CONCLUSION: The study showed that tocilizumab combined with DMARDs was safe and effective in reducing articular and systemic symptoms in patients with an inadequate response to DMARDs.

Effectiveness of a school-based AIDS education program among rural students in HIV high epidemic area of China.

PURPOSE: To evaluate the feasibility and effectiveness of a life-planning skills training program using participatory methods among rural senior high school students in Shangcai County, Henan Province, China. METHODS: The study was a quasi-experimental study conducted in three Shangcai County senior high schools with comparable socioculture-economic and demographic characteristics (two interventions and one control). The intervention, a life-planning skills program that uses participatory training methods, combining information education with effective skills building, was provided to all first-grade students (14-18 years old; 87% of them are between 15 and 17 years old) in the intervention group from October 2003 to December 2003. In total, 717 students from the intervention group, and 457 from the control enrolled at baseline, and over 91% of these were followed up at posttest. RESULTS: Group x time interaction effects in ordinal logistic regression analysis were found on HIV/AIDS-related knowledge (p < .0001), attitudes toward daily contact with HIV-positive persons (p < .0001), and subjects' protection self-efficacy (p < .0001), suggesting the intervention increased subjects' knowledge significantly, changed their attitudes positively, and improved their protection self-efficacy. The intervention also significantly improved subjects' communication with teachers and peers on HIV/AIDS issues (p < .0001). However, no significant change was observed on respondents' attitudes toward premarital sex or their communication with parents between the two surveys (p > .05). CONCLUSIONS: Three months of short-term HIV/AIDS education through life-planning skills training was welcomed by students and positively influenced HIV/AIDS-related knowledge, attitudes, protection self-efficacy, and communication among senior high school students in a rural area with high HIV prevalence.