25385 Secukinumab demonstrates high and sustained efficacy in nail psoriasis: Post hoc analyses from phase III studies in psoriasis and psoriatic arthritis (PsA)

2021 ◽  
Vol 85 (3) ◽  
pp. AB56
Author(s):  
Kristian Reich ◽  
Xenofon Baraliakos ◽  
Laura C. Coates ◽  
Alice B. Gottlieb ◽  
Boni Elewski ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Phase Iii ◽  
Nail Psoriasis ◽  
Sustained Efficacy ◽  
Post Hoc ◽  
Phase Iii Studies

Efficacy and safety of ustekinumab in psoriatic arthritis patients with peripheral arthritis and physician-reported spondylitis: post-hoc analyses from two phase III, multicentre, double-blind, placebo-controlled studies (PSUMMIT-1/PSUMMIT-2)

2016 ◽  
Vol 75 (11) ◽  
pp. 1984-1988 ◽  
Author(s):  
Arthur Kavanaugh ◽  
Lluis Puig ◽  
Alice B Gottlieb ◽  
Christopher Ritchlin ◽  
Yin You ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Activity Index ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Peripheral Arthritis ◽  
Link Type ◽  
Study Results ◽  
Post Hoc

ObjectiveTo evaluate ustekinumab efficacy and safety in psoriatic arthritis (PsA) patients with peripheral arthritis and physician-reported spondylitis (termed the ‘spondylitis subset’).MethodsAdults with active PsA (PSUMMIT-1/PSUMMIT-2, n=615/312) were randomised to ustekinumab 45 mg, 90 mg or placebo at week 0/week 4/q12 week. At week 16, patients with <5% improvement in tender and swollen joints entered blinded early escape. A subset of patients with physician-identified spondylitis was evaluated with spondylitis-specific assessments, including Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score employing C reactive protein (ASDAS-CRP), through week 24.Results256/927 (27.6%) PSUMMIT-1/PSUMMIT-2 patients (placebo/ustekinumab, n=92/164) comprised the evaluable spondylitis subset. At week 24, in this analysis subset, significantly more patients achieved BASDAI20/50/70 responses (54.8%/29.3%/15.3% vs 32.9%/11.4%/0%; p≤0.002), improvement in BASDAI question 2 concerning axial pain (1.85 vs 0.24; p<0.001) and mean per cent ASDAS-CRP improvements (27.8% vs 3.9%; p<0.001) for ustekinumab versus placebo recipients, respectively. Comparable to the overall study population, significant improvements were also achieved in psoriasis, peripheral arthritis, enthesitis, dactylitis, physical function and peripheral joint radiographs in the spondylitis subset.ConclusionsIn this post-hoc analysis of PsA patients with baseline peripheral arthritis and physician-reported spondylitis, ustekinumab-treated patients demonstrated significant improvements in axial signs and symptoms through week 24.Trial registration numberPSUMMIT-1 (NCT01009086, EudraCT 2009-012264-14) and PSUMMIT-2 (NCT01077362, EudraCT 2009-012265-60); post-study results.

Off- and on-time responder post-HOC analyses of pooled opicapone phase III studies

2017 ◽  
Vol 381 ◽  
pp. 725
Author(s):  
A. Lees ◽  
J. Ferreira ◽  
W. Poewe ◽  
O. Rascol ◽  
A. Santos ◽  
...  
Keyword(s):  
Phase Iii ◽  
Post Hoc ◽  
Phase Iii Studies

scholarly journals Safety and efficacy of naldemedine in cancer patients with opioid-induced constipation: a pooled, subgroup analysis of two randomised controlled studies

ESMO Open ◽  
2019 ◽  
Vol 4 (4) ◽  
pp. e000527 ◽  
Author(s):  
Iwao Osaka ◽  
Hiroto Ishiki ◽  
Takaaki Yokota ◽  
Yukio Tada ◽  
Hiroki Sato ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Phase Iii ◽  
Spontaneous Bowel Movement ◽  
Numerical Rating ◽  
Baseline Characteristics ◽  
Randomised Controlled ◽  
Post Hoc ◽  
Phase Iii Studies

ObjectiveThis post hoc, pooled, subgroup analysis of two randomised studies evaluated baseline characteristics that may influence the efficacy and safety of naldemedine in patients with opioid-induced constipation (OIC) and cancer.MethodsData for patients who received 0.2 mg naldemedine or placebo were pooled from randomised, placebo-controlled, phase IIb and phase III studies. Proportions of spontaneous bowel movement (SBM) responders and patients with diarrhoea were assessed for each treatment group. For the patient subgroups with or without possible blood–brain barrier (BBB) disruptions, changes in Numerical Rating Scale (NRS) and Clinical Opioid Withdrawal Scale (COWS) scores were assessed.ResultsA total of 307 patients were included in this analysis (naldemedine: n=155; placebo: n=152). The pooled proportion of SBM responders was 73.5% with naldemedine versus 35.5% with placebo. There was a significant increase in the proportion of SBM responders with naldemedine versus placebo (38.0% (95% CI 27.6% to 48.4%); p<0.0001). Greater proportions of SBM responders and patients who experienced diarrhoea were observed with naldemedine versus placebo in all subgroups. Changes from baseline in NRS and COWS scores were similar with naldemedine or placebo in patients with or without brain metastases.ConclusionsAlthough not powered to detect statistically significant differences in treatment effect among subgroups, this study demonstrated that naldemedine appeared to benefit patients with OIC and cancer, irrespective of baseline characteristics, and did not seem to affect analgesia or withdrawal–even in patients with potential BBB disruptions. Baseline characteristics did not appear to affect the incidence of diarrhoea in patients who received naldemedine.Trial registration numbersJapicCTI-111510 and JapicCTI-132340.

scholarly journals Efficacy and safety of ceftobiprole in patients aged 65 years or older: a post hoc analysis of three Phase III studies

2021 ◽  
Author(s):  
Tobias Welte ◽  
Thomas WL Scheeren ◽  
J Scott Overcash ◽  
Mikael Saulay ◽  
Marc Engelhardt ◽  
...  
Keyword(s):  
Community Acquired Pneumonia ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Skin Structure ◽  
Treatment Groups ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
Hospital Acquired ◽  
Phase Iii Studies

Aim: To evaluate the efficacy and safety of ceftobiprole in patients aged ≥65 years. Materials & methods: We conducted a post hoc analysis of three randomized, double-blind, Phase III studies in patients with acute bacterial skin and skin structure infections, community-acquired pneumonia and hospital-acquired pneumonia. Results: Findings for patients aged ≥65 years (n = 633) were consistent with those for the overall study populations, although a trend toward improved outcomes was reported in some subgroups, for example, patients aged ≥75 years with community-acquired pneumonia were more likely to achieve an early clinical response with ceftobiprole than comparator (treatment difference 16.3% [95% CI:1.8–30.8]). The safety profile was similar between treatment groups in all studies. Conclusion: This analysis further supports the efficacy and safety of ceftobiprole in older patients with acute bacterial skin and skin structure infections or pneumonia. Clinicaltrials.gov trial identifiers: NCT03137173 , NCT00326287 , NCT00210964 , NCT00229008

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