4 research outputs found
Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3)
Get PDFBackground:
The study aimed to assess 52-week efficacy and safety of secukinumab self-administration by autoinjector in patients with active psoriatic arthritis (PsA) in the FUTURE 3 study (ClinicalTrials.gov NCT01989468).
Methods:
Patients (≥ 18 years of age; N = 414) with active PsA were randomized 1:1:1 to subcutaneous (s.c.) secukinumab 300 mg, 150 mg, or placebo at baseline, weeks 1, 2, 3, and 4, and every 4 weeks thereafter. Per clinical response, placebo-treated patients were re-randomized to s.c. secukinumab 300 or 150 mg at week 16 (nonresponders) or week 24 (responders) and stratified at randomization by prior anti-tumor necrosis factor (TNF) therapy (anti-TNF-naïve, 68.1%; intolerant/inadequate response (anti-TNF-IR), 31.9%). The primary endpoint was the proportion of patients achieving at least 20% improvement in American College of Rheumatology response criteria (ACR20) at week 24. Autoinjector usability was evaluated by Self-Injection Assessment Questionnaire (SIAQ).
Results:
Overall, 92.1% (300 mg), 91.3% (150 mg), and 93.4% (placebo) of patients completed 24 weeks, and 84.9% (300 mg) and 79.7% (150 mg) completed 52 weeks. In the overall population (combined anti-TNF-naïve and anti-TNF-IR), ACR20 response rate at week 24 was significantly higher in secukinumab groups (300 mg, 48.2% (p < 0.0001); 150 mg, 42% (p < 0.0001); placebo, 16.1%) and was sustained through 52 weeks. SIAQ results showed that more than 93% of patients were satisfied/very satisfied with autoinjector usage. Secukinumab was well tolerated with no new or unexpected safety signals reported.
Conclusions:
Secukinumab provided sustained improvements in signs and symptoms in active PsA patients through 52 weeks. High acceptability of autoinjector was observed. The safety profile was consistent with that reported previously
Additional file 1: of Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3)
Get PDFFigure S1. Showing study design, Table S1. Presenting independent ethics committees (IECs) or institutional review boards (IRB) by study center, Table S2. Presenting a summary of observed efficacy data at week 52 among patients randomized to secukinumab at baseline, Table S3. Presenting patient-reported acceptability of the autoinjector, and Table S4. Presenting SAEs by SOC reported across the entire study period. (DOCX 438 kb
A Bibliography on the Social and Economic Phases of Dentistry and Other Health Services**This bibliography is the result of a cooperative effort on the part of Dr. L. E. Kurth, Mrs. Josephine Hunt, Librarian of the American Dental Association, and Dr. H. E. Phillips, and is sponsored by the Economics Committee of the American Dental Association of which Dr. E. H. Bruening is chairman. Other members of the Committee are Drs. John T. Hanks, R. H. Miller, H. W. Oppice and Leland R. Packwood. The Committee recognizing the need of such a bibliography had arranged that the work be done in the American Dental Association Library. When it was learned that Doctors Kurth and Phillips had already started such a bibliography, a joint effort in completing the work was agreed on. Much of this material is available from the American Dental Association Library Bureau.Such topics as would be included under the subject headings voluntary insurance, compulsory insurance, state dentistry, state medicine and socialized medicine are included in the bibliography.
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