Open AccessUse of the interleukin-17A inhibitor secukinumab in psoriatic arthritis: a subanalysis of the Russian population in the international randomized clinical trials FUTURE 1 and FUTURE 2
Author(s) -
Т. В. Коротаева,
Е. Г. Зоткин,
О. Б. Несмеянова,
Н. Н. Везикова,
О. Б. Ершова,
Н. В. Измозжерова,
М. С. Петрова,
А. А. Кастанян,
С. П. Якупова,
Alina S. Agaf'ina,
Marina Stanislav,
Е. А. Новодережкина,
Е. Л. Насонов,
Philip J Mease
Publication year - 2017
Publication title -
naučno-praktičeskaâ revmatologiâ
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.137
H-Index - 9
eISSN - 1995-4492
pISSN - 1995-4484
DOI - 10.14412/1995-4484-2017-151-158
Subject(s) - medicine , secukinumab , psoriatic arthritis , incidence (geometry) , concomitant , placebo , population , methotrexate , gastroenterology , clinical trial , randomized controlled trial , psoriasis , oncology , rheumatoid arthritis , surgery , dermatology , pathology , physics , alternative medicine , environmental health , optics
The investigators carried out an analysis of the efficacy and safety of secukinumab (SEC) in the randomized placebocontrolled trials (RPCTs) FUTURE 1 and FUTURE 2, as well as a subanalysis of the data obtained in the Russian population of patients with active psoriatic arthritis (PsA). The FUTURE 1 and FUTURE 2 trials enrolled a total of 1003 patients with active PsA. They received SEC (n = 703) or placebo (PL) (n = 300). The use of SEC 300 or 150 mg without previous intravenous (IV) loading dose or either 150 or 75 mg with the IV loading dose led to a significant improvement in patients with PsA. The positive changes in the main clinical manifestations of PsA at 24 weeks persisted until 52 weeks of therapy. SEC was effective in both the patients who had not previously received tumor necrosis factor-α inhibitors and those who had previously taken these drugs, and the result of therapy did not depend on concomitant methotrexate use. The incidence of cancer was low and comparable in the SEC and PL groups. Analysis of the combined data on the safety of the two RPCTs showed that the treatment duration-adjusted incidence of malignant neoplasms was 0.5 per 100 patient-years in the SEC groups and 0.9 in the PL groups. The safety profile of SEC in these RPCTs corresponds to that in the previous studies of the drug. The data from the pooled analysis of the Russian subpopulation of patients with PsA fully agree with the results obtained in the evaluation of all the patients included in FUTURE 1 and FUTURE 2 and confirm the most important role of IL-17А in the pathogenesis of PsA.