Table 2. Clinical trials of biological agents for the treatment of polymyalgia rheumatica and giant cell arteritis Mechanism Publicat. Sample Study Durat. Main results Ref. of action type information size population Polymyalgia rheumatica Randomized, Did not achieve primary PMR, new 52 Salvarani Infliximab Full paper 51 and main secondary TNF- blocker untreated weeks 2007 130 double-blinded endpoints Randomized, Did not achieve primary PMR, new Kreiner Etanercept TNF- blocker Full paper single-centre, 22 14 days and main secondary untreated 2010 134 double-blinded endpoints Relapse-free remission off GCs at 6 months: 100% in TCZ vs. 0% in control group Not randomized, PMR, new IL-6 receptor 15 Cumulative GC dose: 1.1g Lally 2016 Tocilizumab Full paper single-centre 20 treated with blocker months in TCZ vs. 2.6g in control 135 GCs month ≤1 group (p=0.01) Duration of GC exposure: 3.9 in TCZ vs. 14.1 months in control (p=0.002) PMR <12mo, PMR-AS≤10 at 12weeks: Single group, IL-6 receptor GC-naive or 24 Tocilizumab Full paper multi-centre 20 100%, no flares blockade GCs<1mo + off weeks open-label Cumulative GC dose: 0.8g 2016 136 GCs 7 days AIN457 IL-17 blocker Final report 16 PMR, new 2 weeks Did not achieve primary Matteson Randomized, endpoint 2014 146 IL1 blocker Proof of ACZ885 Concept Study
Table 2. Clinical trials of biological agents for the treatment of polymyalgia rheumatica and giant cell arteritis Mechanism of action Publicat. type information Sample size Study population Durat. Main results Ref. Polymyalgia rheumatica Infliximab TNF- blocker Full paper Randomized, double-blinded 51 PMR, new untreated 52 weeks Did not achieve primary and main secondary endpoints Salvarani 2007 130 Etanercept TNF- blocker Full paper Randomized, single-centre, double-blinded 22 PMR, new untreated 14 days Did not achieve primary and main secondary endpoints Kreiner 2010 134 Tocilizumab IL-6 receptor blocker Full paper Not randomized, single-centre 20 PMR, new treated with GCs ≤1 month 15 months Relapse-free remission off GCs at 6 months: 100% in TCZ vs. 0% in control group Cumulative GC dose: 1.1g in TCZ vs. 2.6g in control group (p=0.01) Duration of GC exposure: 3.9 in TCZ vs. 14.1 months in control (p=0.002) Lally 2016 135 Tocilizumab IL-6 receptor blockade Full paper Single group, multi-centre open-label 20 PMR <12mo, GC-naive or GCs<1mo + off GCs 7 days 24 weeks PMR-AS≤10 at 12weeks: 100%, no flares Cumulative GC dose: 0.8g 2016 136 AIN457 ACZ885 IL-17 blocker IL1 blocker Final report Randomized, Proof of Concept Study 16 PMR, new 2 weeks Did not achieve primary endpoint Matteson 2014 146
170706%20Dasgupta_accepted.docx