TY - JOUR
T1 - Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial
AU - McInnes, Iain B.
AU - Mease, Philip J.
AU - Kirkham, Bruce
AU - Kavanaugh, Arthur
AU - Ritchlin, Christopher T.
AU - Rahman, Proton
AU - van der Heijde, Désirée
AU - Landewé, Robert
AU - Conaghan, Philip G.
AU - Gottlieb, Alice B.
AU - Richards, Hanno
AU - Pricop, Luminita
AU - Ligozio, Gregory
AU - Patekar, Manmath
AU - Mpofu, Shephard
AU - AUTHOR GROUP
AU - Bird, Paul
AU - Hall, Stephen
AU - Nash, Peter
AU - Zochling, Jane
AU - de Vlam, Kurt
AU - Langenaken, Christine
AU - Geusens, Piet
AU - Beaulieu, Andre
AU - Tremblay, Jean-Luc
AU - McCarthy, Tim
AU - Papp, Kim
AU - Poulin, Yves
AU - Cohen, Martin
AU - Galatikova, Dagmar
AU - Dokoupilova, Eva
AU - Dvorak, Zdenek
AU - Mann, Herman
AU - Sieper, Joachim
AU - Spieler, Wolfgang
AU - Kurthen, Reiner
AU - Braun, Juergen
AU - Wollenhaupt, Juergen
AU - Tony, Hans-Peter
AU - Schuch, Florian
AU - Schulze-Koops, Hendrik
AU - Rech, Juergen
AU - Leszczynski, Piotr
AU - Adamski, Zygmunt
AU - Szepietowski, Jacek
AU - Tlustochowicz, Witold
AU - Kaszuba, Andrzej
AU - Szymanska, Malgorzata
AU - Stanislav, Marina
AU - Nesmeyanova, Olga
AU - Vezikova, Natalia
PY - 2015
Y1 - 2015
N2 - Background Interleukin 17A is a proinflammatory cytokine that is implicated in the pathogenesis of psoriatic arthritis. We assessed the efficacy and safety of subcutaneous secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis. Methods In this phase 3, double-blind, placebo-controlled study undertaken at 76 centres in Asia, Australia, Canada, Europe, and the USA, adults (aged >= 18 years old) with active psoriatic arthritis were randomly allocated in a 1: 1: 1: 1 ratio with computer-generated blocks to receive subcutaneous placebo or secukinumab 300 mg, 150 mg, or 75 mg once a week from baseline and then every 4 weeks from week 4. Patients and investigators were masked to treatment assignment. The primary endpoint was the proportion of patients achieving at least 20% improvement in the American College of Rheumatology response criteria (ACR20) at week 24. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01752634. Findings Between April 14, and Nov 25, 2013, 397 patients were randomly assigned to receive secukinumab 300 mg (n=100), 150 mg (n=100), 75 mg (n=99), or placebo (n=98). A significantly higher proportion of patients achieved an ACR20 at week 24 with secukinumab 300 mg (54 [54%] patients; odds ratio versus placebo 6.81, 95% CI 3.42-13.56; p <0.0001), 150 mg (51 [51%] patients; 6.52, 3.25-13.08; p <0.0001), and 75 mg (29 [29%] patients; 2.32, 1.14-4.73; p=0.0399) versus placebo (15 [15%] patients). Up to week 16, the most common adverse events were upper respiratory tract infections (four [4%], eight [8%], ten [10%], and seven [7%] with secukinumab 300 mg, 150 mg, 75 mg, and placebo, respectively) and nasopharyngitis (six [6%], four [4%], six [6%], and eight [8%], respectively). Serious adverse events were reported by five (5%), one (1%), and four (4%) patients in the secukinumab 300 mg, 150 mg, and 75 mg groups, respectively, compared with two (2%) in the placebo group. No deaths were reported. Interpretation Subcutaneous secukinumab 300 mg and 150 mg improved the signs and symptoms of psoriatic arthritis, suggesting that secukinumab is a potential future treatment option for patients with this disorder
AB - Background Interleukin 17A is a proinflammatory cytokine that is implicated in the pathogenesis of psoriatic arthritis. We assessed the efficacy and safety of subcutaneous secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis. Methods In this phase 3, double-blind, placebo-controlled study undertaken at 76 centres in Asia, Australia, Canada, Europe, and the USA, adults (aged >= 18 years old) with active psoriatic arthritis were randomly allocated in a 1: 1: 1: 1 ratio with computer-generated blocks to receive subcutaneous placebo or secukinumab 300 mg, 150 mg, or 75 mg once a week from baseline and then every 4 weeks from week 4. Patients and investigators were masked to treatment assignment. The primary endpoint was the proportion of patients achieving at least 20% improvement in the American College of Rheumatology response criteria (ACR20) at week 24. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01752634. Findings Between April 14, and Nov 25, 2013, 397 patients were randomly assigned to receive secukinumab 300 mg (n=100), 150 mg (n=100), 75 mg (n=99), or placebo (n=98). A significantly higher proportion of patients achieved an ACR20 at week 24 with secukinumab 300 mg (54 [54%] patients; odds ratio versus placebo 6.81, 95% CI 3.42-13.56; p <0.0001), 150 mg (51 [51%] patients; 6.52, 3.25-13.08; p <0.0001), and 75 mg (29 [29%] patients; 2.32, 1.14-4.73; p=0.0399) versus placebo (15 [15%] patients). Up to week 16, the most common adverse events were upper respiratory tract infections (four [4%], eight [8%], ten [10%], and seven [7%] with secukinumab 300 mg, 150 mg, 75 mg, and placebo, respectively) and nasopharyngitis (six [6%], four [4%], six [6%], and eight [8%], respectively). Serious adverse events were reported by five (5%), one (1%), and four (4%) patients in the secukinumab 300 mg, 150 mg, and 75 mg groups, respectively, compared with two (2%) in the placebo group. No deaths were reported. Interpretation Subcutaneous secukinumab 300 mg and 150 mg improved the signs and symptoms of psoriatic arthritis, suggesting that secukinumab is a potential future treatment option for patients with this disorder
U2 - https://doi.org/10.1016/S0140-6736(15)61134-5
DO - https://doi.org/10.1016/S0140-6736(15)61134-5
M3 - Article
C2 - 26135703
SN - 0140-6736
VL - 386
SP - 1137
EP - 1146
JO - Lancet
JF - Lancet
IS - 9999
ER -