McInnes, I. B. et al. (2015) Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet, 386(9999), pp. 1137Lancet, 386(9999), pp. -1146 This is the accepted version.

BackgroundSince the publication of the European League Against Rheumatism recommendations for the pharmacological treatment of psoriatic arthritis (PsA) in 2012, new evidence and new therapeutic agents have emerged. The objective was to update these recommendations.MethodsA systematic literature review was performed regarding pharmacological treatment in PsA. Subsequently, recommendations were formulated based on the evidence and the expert opinion of the 34 Task Force members. Levels of evidence and strengths of recommendations were allocated.ResultsThe updated recommendations comprise 5 overarching principles and 10 recommendations, covering pharmacological therapies for PsA from non-steroidal anti-inflammatory drugs (NSAIDs), to conventional synthetic (csDMARD) and biological (bDMARD) disease-modifying antirheumatic drugs, whatever their mode of action, taking articular and extra-articular manifestations of PsA into account, but focusing on musculoskeletal involvement. The overarching principles address the need for shared decision-making and treatment objectives. The recommendations address csDMARDs as an initial therapy after failure of NSAIDs and local therapy for active disease, followed, if necessary, by a bDMARD or a targeted synthetic DMARD (tsDMARD). The first bDMARD would usually be a tumour necrosis factor (TNF) inhibitor. bDMARDs targeting interleukin (IL)12/23 (ustekinumab) or IL-17 pathways (secukinumab) may be used in patients for whom TNF inhibitors are inappropriate and a tsDMARD such as a phosphodiesterase 4-inhibitor (apremilast) if bDMARDs are inappropriate. If the first bDMARD strategy fails, any other bDMARD or tsDMARD may be used.ConclusionsThese recommendations provide stakeholders with an updated consensus on the pharmacological treatment of PsA and strategies to reach optimal outcomes in PsA, based on a combination of evidence and expert opinion.

A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active psoriatic arthritis List of tables List of figures Glossary of termsAssessment A procedure used to generate data required by the study Control drug A study drug used as a comparator to reduce assessment bias, preserve blinding of investigational drug, assess internal study validity, and/or evaluate comparative effects of the investigational drug Enrollment Point/time of patient entry into the study; the point at which informed consent must be obtained (i.e. prior to starting any of the procedures described in the protocol)Inadequate response to TNFα Active disease despite stable treatment with anti-TNFa for at least 3 months at a stable dose or for at least one dose in the case of lack of tolerance Investigational drugThe study drug whose properties are being tested in the study; this definition is consistent with US CFR 21 Section 312.3 and is synonymous with "investigational new drug."Medication number A unique identifier on the label of each study drug package in studies that dispense study drug using an IVR systemPatient number A number assigned to each patient who enrolls in the study. When combined with the center number, a unique identifier is created for each patient in the study. PeriodA minor subdivision of the study timeline; divides phases into smaller functional segments such as screening, baseline, titration, washout, etc.Phase A major subdivision of the study timeline; begins and ends with major study milestones such as enrollment, randomization, completion of treatment, etc.Premature patient withdrawal Point/time when the patient exits from the study prior to the planned completion of all study drug administration and assessments; at this time all study drug administration is discontinued and no further assessments are plannedRandomization number A unique identifier assigned to each randomized patient, corresponding to a specific treatment arm assignment Stop study participation Point/time at which the patient came in for a final evaluation visit or when study drug was discontinued whichever is later Study drug Any drug administered to the patient as part of the required study procedures; includes investigational drug and any control drugs Study drug discontinuation Point/time when patient permanently stops taking study drug for any reason; may or may not also be the point/time of premature patient withdrawal Variable Information used in the data analysis; derived directly or indirectly from data collected using specified assessments at specified timepointsThis document (090095a88362b521 in docbase CREDI_BS) has been digitally signed with external signatures using Entrust PKI. Protocol synopsisTitle of study: A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and...