Efficacy of tocilizumab in patients with hand osteoarthritis: double blind, randomised, placebo-controlled, multicentre trial.

OBJECTIVE: To evaluate the efficacy of tocilizumab, an antibody against IL-6 receptor, in patients with hand osteoarthritis. METHODS: This was a multicentre, 12-week, randomised, double-blind, placebo-controlled study from November 2015 to October 2018. Patients with symptomatic hand osteoarthritis (pain ≥40 on a 0-100 mm visual analogue scale (VAS) despite analgesics and non-steroidal anti-inflammatory drugs; at least three painful joints, Kellgren-Lawrence grade ≥2) were randomised to receive two infusions 4 weeks apart (weeks 0 and 4) of tocilizumab (8 mg/kg intravenous) or placebo. The primary endpoint was changed in VAS pain at week 6. Secondary outcomes included the number of painful and swollen joints, duration of morning stiffness, patients' and physicians' global assessment and function scores. RESULTS: Of 104 patients screened, 91 (45 to tocilizumab and 46 to placebo; 82% women; mean age 64.4 (SD 8.7) years) were randomly assigned and 79 completed the 12-week study visit. The mean change between baseline and week 6 on the VAS for pain (primary outcome) was -7.9 (SD 19.4) and -9.9 (SD 20.1) in the tocilizumab and placebo groups (p=0.7). The groups did not differ for any secondary outcomes at weeks 4, 6, 8 or 12. Overall, adverse events were slightly more frequent in the tocilizumab than placebo group. CONCLUSION: Tocilizumab was no more effective than placebo for pain relief in patients with hand osteoarthritis.

Tocilizumab in treatment-naïve patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labeled trial.

OBJECTIVES: To assess long-term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK). METHODS: Prospective open-labeled trial in naïve patients with TAK who received steroids at the dose of 0.7 mg/kg/day and 7 infusions of 8 mg/kg/month of tocilizumab. The primary endpoint was the number of patients who discontinued steroids after 7 infusions of tocilizumab. Secondary endpoints included disease activity and the number of relapses during 18-month follow-up. RESULTS: Thirteen patients with TAK were included, with a median age of 32 years [19-45] and 12 (92%) females. Six (54%) patients met the primary end-point. A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3, 4] at baseline, versus 1 [0-2] after 6 months; p < 0.001), ITAS-2010 score (5 [2-7] versus 3 [0-8]; p = 0.002), and ITAS-A score (7 [4-10] versus 4 [1-15]; p = 0.0001)]. During the 12-month follow-up after tocilizumab discontinuation, a relapse occurred among 5 patients (45%) out of 11 in which achieved remission after 6 months of tocilizumab. CONCLUSION: Tocilizumab seems an effective steroid sparing therapy in TAK, but maintenance therapy is necessary. TRIAL REGISTRATION: ClinicalTrials.gov NCT02101333 . Registered on 02 April 2014.

Effect of brain-dead donor resuscitation on delayed graft function: results of a monocentric analysis.

BACKGROUND: We have previously shown that a delayed graft function (DGF) longer than 6 days was a crucial threshold for long-term graft outcome. The aim of this study was to analyze the correlation of DGF >or=6 days with brain-dead donor variables, including those related to resuscitation, in a population of 262 consecutive brain-dead donors from 1990 to 2003. METHODS: We used a marginal logistic model in which DGF was considered as a binary variable with a cutoff of 6 days. RESULTS: Monovariate analysis of donor parameters showed that male, age above 35 years, primary history of hypertension, hydroxyethyl starch (HES) fluid greater than 1500 mL or epinephrine infusion during resuscitation were risk factors for prolonged DGF. The multivariate logistic regression model showed that epinephrine use during donor resuscitation (P<0.001, odds ratio [OR]=4.35), cold ischemia time (CIT) >or=16 hr (P=0.01, OR=2.16), and recipient age >55 years (P=0.003, OR=2.75), were associated with a risk of prolonged DGF. A long stay (>40 hr) in intensive care and a large volume of colloids (>1250 mL, except HES) correlated with a lower risk of DGF. CONCLUSION: Our study shows an impact for only a limited number of brain dead donor resuscitation parameters on DGF duration. We also show that CIT has a much lower threshold (<16 hr) for DGF risk than previously described. Importantly, we show that recipient age is clearly a major independent risk factor for prolonged DGF, whereas donor age seems to act mostly as a dependent risk factor.