Faculty Opinions recommendation of Fel d 1-derived peptide antigen desensitization shows a persistent treatment effect 1 year after the start of dosing: a randomized, placebo-controlled study.

3574 Background: VELOUR, a large, international, randomized, placebo (pbo)-controlled study, compared efficacy and safety of FOLFIRI with ziv-aflibercept (known as aflibercept outside the United States) or with pbo in 1,226 metastatic colorectal cancer patients who received prior oxaliplatin treatment. Ziv-aflibercept demonstrated statistically significant, clinically meaningful improvements in median overall survival (OS) (13.5 vs 12.06 mos; hazard ratio [HR]=0.817, P=0.0032), progression-free survival, and response rate. This analysis estimates treatment effect and safety over time course of the study. Methods: HRs by 6-mo time periods were estimated using piecewise Cox proportional hazard model. NCI-CTCAE v3.0 was used to grade adverse event (AE) severity. Results: HR improved over time (Table), consistent with survival curves that continue to separate past the median time point, indicating that the magnitude of ziv-aflibercept treatment effect continues to increase over time. Incidence of grade 3 AEs (45.1% vs 62.0%) was higher in the ziv-aflibercept/FOLFIRI arm; incidences of grade 4 AEs were 17.4% (pbo) vs 21.4% (ziv-aflibercept). More common AEs only occurred in a small proportion of ziv-aflibercept/FOLFIRI cycles (eg, grade ≥3 hypertension and diarrhea occurred in 3.6% and 2.8% of cycles, respectively). The majority of grade 3/4 AEs occurred in early treatment (first 3-4 cycles). Most patients experienced only a single episode of grade ≥3 AEs with ziv-aflibercept/FOLFIRI. Importantly, AEs in VELOUR did not impact patients’ ability to receive chemotherapy. Conclusions: Treatment with ziv-aflibercept/FOLFIRI showed continuous, consistent improvement in OS over time. While combined grade 3/4 AEs were higher with ziv-aflibercept, AEs occurred early in treatment in a small proportion of total cycles; the majority were single-episode in nature. Clinical trial information: NCT00561470. [Table: see text]

Download Full-text

Low-dose Infliximab (3 mg/kg) Significantly Reduces Spinal Inflammation on Magnetic Resonance Imaging in Patients with Ankylosing Spondylitis: A Randomized Placebo-controlled Study

The Journal of Rheumatology ◽

10.3899/jrheum.091043 ◽

2010 ◽

Vol 37 (8) ◽

pp. 1728-1734 ◽

Cited By ~ 40

Author(s):

WALTER P. MAKSYMOWYCH ◽

DAVID SALONEN ◽

ROBERT D. INMAN ◽

PROTON RAHMAN ◽

ROBERT G.W. LAMBERT

Keyword(s):

Magnetic Resonance Imaging ◽

Ankylosing Spondylitis ◽

Magnetic Resonance ◽

Treatment Effect ◽

Low Dose ◽

High Reliability ◽

Controlled Study ◽

Resonance Imaging ◽

Large Treatment Effect ◽

Spinal Inflammation

Objective.To evaluate the influence of low-dose infliximab (IFX) on spinal inflammation scored by magnetic resonance imaging (MRI). The dose recommended for rheumatoid arthritis (3 mg/kg) is also clinically effective for ankylosing spondylitis (AS), although effects on spinal inflammation as defined by MRI have yet to be described in a placebo-controlled trial.Methods.In a 12-week double-blind period, patients were randomized 1:1 to receive either IFX 3 mg/kg at 0, 2, and 6 weeks, or placebo. Spinal inflammation in discovertebral units (DVU) was measured by the Spondyloarthritis Research Consortium of Canada (SPARCC) MRI Index at baseline and 12 weeks by 3 readers blinded to timepoint and treatment allocation. We also compared reliability and discrimination of the SPARCC MRI index based on evaluation of the entire spine (23 DVU score) compared to assessment of only the 6 most severely affected DVU (6 DVU score).Results.At Week 12, patients treated with IFX experienced mean reductions of 55.1% and 57.2% in the 6 DVU and 23 DVU SPARCC scores, respectively, compared with a mean increase of 5.8% and decrease of 3.4% in 6 DVU and 23 DVU scores, respectively, for patients taking placebo (p < 0.001). A large treatment effect (Guyatt’s effect size ≥ 1.7) and high reliability was evident and comparable between 6 DVU and 23 DVU scoring methods.Conclusion.Treatment with low-dose IFX leads to a large treatment effect on spinal inflammation as measured by MRI. Scoring for inflammation of only the most severely affected regions of the spine by MRI is comparable to assessment of the entire spine.

Download Full-text

Persistent Treatment Effect Achieved at One Year After 4 Doses of Fel d 1-Derived Peptide Immunotherapy in an Environmental Exposure Chamber (EEC) Model of Cat Allergy

Journal of Allergy and Clinical Immunology ◽

10.1016/j.jaci.2011.12.485 ◽

2012 ◽

Vol 129 (2) ◽

pp. AB144

Author(s):

R.P. Hafner ◽

J. Efthimiou ◽

A. Salapatek ◽

D. Patel ◽

M. Larche

Keyword(s):

Environmental Exposure ◽

Treatment Effect ◽

Exposure Chamber ◽

Peptide Immunotherapy ◽

Cat Allergy ◽

Fel D 1 ◽

One Year ◽

Environmental Exposure Chamber

Download Full-text

1. Two Year Persistent Treatment Effect Achieved After 4 Doses of Cat-Peptide Antigen Desensitization (Cat-PAD) in an Environmental Exposure Chamber (EEC) Model of Cat Allergy

Journal of Allergy and Clinical Immunology ◽

10.1016/j.jaci.2012.12.1185 ◽

2013 ◽

Vol 131 (2) ◽

pp. AB147 ◽

Cited By ~ 5

Author(s):

Rod Hafner ◽

Peter Couroux ◽

Kristen Armstrong ◽

Deepen Patel ◽

Mark Larche

Keyword(s):

Environmental Exposure ◽

Treatment Effect ◽

Exposure Chamber ◽

Peptide Antigen ◽

Cat Allergy ◽

Environmental Exposure Chamber

Download Full-text

Clopidogrel as prophylactic treatment for migraine: A pilot randomised, controlled study

Cephalalgia ◽

10.1177/0333102414531156 ◽

2014 ◽

Vol 34 (14) ◽

pp. 1163-1168 ◽

Cited By ~ 7

Author(s):

John B Chambers ◽

Paul T Seed ◽

Leone Ridsdale

Keyword(s):

Treatment Effect ◽

Randomised Trial ◽

Placebo Treatment ◽

Controlled Study ◽

Atrial Septal Aneurysm ◽

Significant Treatment ◽

Headache Severity ◽

Randomised Controlled Study ◽

Headache Diary ◽

Randomised Controlled

Introduction Anecdotal reports suggest that clopidogrel may prevent migraine attacks. We undertook a pilot randomised trial. Method We randomised consecutive migraineurs with four to 15 headache days per 28-day month to receive clopidogrel 75 mg or placebo daily for three months. Headache was primarily assessed with a headache diary. Results There were no statistically significant treatment effects. The number of headache days fell by 1.9 on clopidogrel and 1.6 on placebo (adjusted difference 0.02, CI −2.07 to 2.12). Headache severity rose by 0.14 points (out of 10) on clopidogrel, and fell by 0.63 on placebo; treatment effect 0.7 points (CI −0.11 to 1.57). The main treatment effect did not depend on the presence or absence of migraine with aura at baseline, a patent foramen ovale (PFO) or atrial septal aneurysm. Discussion The evidence is inconclusive, but a multicentre trial would be feasible recruiting from primary care.

Download Full-text