scholarly journals Improvement of Signs and Symptoms of Nonradiographic Axial Spondyloarthritis in Patients Treated With Secukinumab: Primary Results of a Randomized, Placebo‐Controlled Phase III Study

2020 ◽  
Vol 73 (1) ◽  
pp. 110-120 ◽  
Author(s):  
Atul Deodhar ◽  
Ricardo Blanco ◽  
Eva Dokoupilová ◽  
Stephen Hall ◽  
Hideto Kameda ◽  
...  
Keyword(s):  
Axial Spondyloarthritis ◽  
Signs And Symptoms ◽  
Phase Iii ◽  
Phase Iii Study ◽  
Nonradiographic Axial Spondyloarthritis

scholarly journals Secukinumab in non-radiographic axial spondyloarthritis: subgroup analysis based on key baseline characteristics from a randomized phase III study, PREVENT

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Jürgen Braun ◽  
Ricardo Blanco ◽  
Helena Marzo-Ortega ◽  
Lianne S. Gensler ◽  
Filip van den Bosch ◽  
...  
Keyword(s):  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Human Leukocyte ◽  
Signs And Symptoms ◽  
Response Rates ◽  
Phase Iii ◽  
Inactive Disease ◽  
Hla B27 ◽  
Female Patients ◽  
Link Type

Abstract Background To investigate the efficacy of secukinumab in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) grouped by disease activity as assessed by C-reactive protein (CRP) levels and/or magnetic resonance imaging (MRI) scores, human leukocyte antigen (HLA)-B27 status, and sex. Methods The phase III PREVENT study randomized (1:1:1) 555 patients to receive subcutaneous secukinumab 150 mg with (LD) or without (NL) loading dose or placebo weekly, followed by every 4 weeks starting at week 4. Here, we report the results of a post hoc analysis reporting the efficacy outcomes (pooled secukinumab) to 16 weeks by CRP, MRI, HLA-B27, and sex. Results Efficacy differences between the secukinumab and the placebo groups were highest in the CRP+, MRI+, HLA-B27+, and male subgroups, particularly for Ankylosing Spondylitis Disease Activity Score-CRP inactive disease and Assessment of SpondyloArthritis international Society (ASAS) partial remission outcomes. ASAS40 response rates in the CRP+/MRI+ subgroup was 52.3% (secukinumab) versus 21.8% (placebo; P < 0.0001) at week 16. ASAS40 response rates (secukinumab versus placebo) were 43.9% versus 32.6% in HLA-B27+, 32.7% versus 16.4% in HLA-B27− subgroups, 51.2% versus 30.8% in male, and 31.7% versus 25.3% in female patients, respectively. Conclusions Secukinumab improved the signs and symptoms of nr-axSpA across patients grouped by CRP (+/−) and/or MRI (+/−) status, HLA-B27 (+/−) status, and sex. The highest treatment differences between secukinumab and placebo were observed in patients with both elevated CRP and evidence of sacroiliitis on MRI. Treatment difference was minimal between HLA-B27 (+) and (−) subgroups. Male patients had higher relative responses than female patients. Trial registration ClinicalTrials.gov, NCT02696031. Registered on 02 March 2016

Pasireotide treatment significantly improves clinical signs and symptoms in patients with Cushing's disease: results from a Phase III study

2014 ◽  
Vol 81 (3) ◽  
pp. 408-417 ◽  
Author(s):  
Rosario Pivonello ◽  
Stephan Petersenn ◽  
John Newell-Price ◽  
James W. Findling ◽  
Feng Gu ◽  
...  
Keyword(s):  
Cushing’S Disease ◽  
Clinical Signs ◽  
Signs And Symptoms ◽  
Phase Iii ◽  
Cushing's Disease ◽  
Phase Iii Study ◽  
Clinical Signs And Symptoms

scholarly journals Ixekizumab treatment of biologic-naïve patients with active psoriatic arthritis: 3-year results from a phase III clinical trial (SPIRIT-P1)

Rheumatology ◽  
2020 ◽  
Vol 59 (10) ◽  
pp. 2774-2784 ◽  
Author(s):  
Vinod Chandran ◽  
Désirée van der Heijde ◽  
Roy M Fleischmann ◽  
Eric Lespessailles ◽  
Philip S Helliwell ◽  
...  
Keyword(s):  
Radiographic Progression ◽  
Signs And Symptoms ◽  
Severity Index ◽  
Incidence Rates ◽  
Phase Iii ◽  
Biologic Treatment ◽  
Serious Adverse Events ◽  
Phase Iii Study ◽  
Modified Total Sharp Score ◽  
Inadequate Responders

Abstract Objective The aim was to assess the safety and efficacy of up to 156 weeks of ixekizumab (an IL-17A antagonist) treatment in PsA patients. Methods In a phase III study, patients naïve to biologic treatment were randomized to placebo, adalimumab 40 mg every 2 weeks (ADA; active reference) or ixekizumab 80 mg every 2 weeks (IXEQ2W) or every 4 weeks (IXEQ4W) after an initial dose of 160 mg. At week 24 (week 16 for inadequate responders), ADA (after 8-week washout) and placebo patients were re-randomized to IXEQ2W or IXEQ4W. Outcomes were evaluated using a modified non-responder imputation [linear extrapolation for radiographic progression (modified total Sharp score = 0)] during extended treatment until week 156. Results Of 417 patients, 381 entered the extension, and 243 of 381 (63.8%) completed the 156-week study. Incidence rates of treatment-emergent and serious adverse events, respectively, were 38.0 and 5.2 with IXEQ2W (n = 189) and 38.1 and 8.0 with IXEQ4W (n = 197). One death occurred (IXEQ4W). With IXEQ2W and IXEQ4W, respectively, the response rates persisted to week 156 as measured by the ACR response ≥20% (62.5 and 69.8%), ≥50% (56.1 and 51.8%) and ≥70% (43.8 and 33.4%), psoriasis area and severity index (PASI) 75 (69.1 and 63.5%), PASI 90 (64.5 and 51.2%) and PASI 100 (60.5 and 43.6%). Inhibition of radiographic progression also persisted to week 156 in 61% of IXEQ2W and 71% of IXEQ4W patients. Conclusion In this 156-week study of ixekizumab, the safety profile remained consistent with previous reports, and improvements in signs and symptoms of PsA were observed, including persistent low rates of radiographic progression. Trial registration ClinicalTrials.gov, http://clinicaltrials.gov, NCT01695239, EudraCT 2011-002326-49.

Phase III Study Makes Case for IV Chemoradiation

2007 ◽  
Vol 38 (1) ◽  
pp. 46-47
Author(s):  
BRUCE WILSON
Keyword(s):  
Phase Iii ◽  
Phase Iii Study

Treatment of Genotype 1 HCV Treatment-Naïve Patients: final results of phase III study ADVANCE

2011 ◽  
Vol 49 (01) ◽  
Author(s):  
T Berg ◽  
P Buggisch ◽  
P Malinski ◽  
H Diepolder ◽  
S Mauss ◽  
...  
Keyword(s):  
Phase Iii ◽  
Genotype 1 ◽  
Hcv Treatment ◽  
Treatment Naïve ◽  
Phase Iii Study
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