Administration of subcutaneous interferon beta 1a in the evening: data from RELIEF study

Patti, Francesco; Zimatore, Giovanni Bosco; Morra, Vincenzo Brescia; Aguglia, Umberto; Bossio, Roberto Bruno; Marziolo, R.; Valentino, Paola; Chisari, Clara Grazia; Capacchione, Antonio; Zappia, Mario

doi:10.1007/s00415-020-09771-x

Cited by 5 publications

(2 citation statements)

References 27 publications

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“…Furthermore, there were no reported effects of time of day of dosing on sleep quality, fatigue severity, or circulating leptin, resistin, and adiponectin after 12 weeks of IFN-β1a therapy. 166 Limited and conflicting data make it impossible to determine maximal effectiveness of IFN-β1a therapy based on time of day of dosing (Table 3). To our knowledge, no other disease modifying treatments (such as glatiramer acetate, dimethyl fumarate, teriflunomide, siponimod, mitoxantrone, natalizumab, fingolimod, etc.)…”

Section: Rheumatoid Arthritismentioning

confidence: 99%

“…Conversely, a recent randomized controlled parallel‐group trial in 200 patients with relapsing MS comparing morning and evening dosing of IFN‐β1a across 12 weeks of treatment reported that the morning administration group reported more intense flu‐like symptoms at weeks 4 and 8, however, by week 12, there were no differences in symptoms between groups. Furthermore, there were no reported effects of time of day of dosing on sleep quality, fatigue severity, or circulating leptin, resistin, and adiponectin after 12 weeks of IFN‐β1a therapy 166 . Limited and conflicting data make it impossible to determine maximal effectiveness of IFN‐β1a therapy based on time of day of dosing ( Table 3 ).…”

Section: Immune Systemmentioning

confidence: 99%

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Circadian Variation in Efficacy of Medications

Walton

Walker

Bumgarner

et al. 2020

Clin Pharma and Therapeutics

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Although much has been learned about circadian clocks and rhythms over the past few decades, translation of this foundational science underlying the temporal regulation of physiology and behavior to clinical applications has been slow. Indeed, acceptance of the modern study of circadian rhythms has been blunted because the phenomenology of cyclic changes had to counteract the 20th century dogma of homeostasis in the biological sciences and medicine. We are providing this review of clinical data to highlight the emerging awareness of circadian variation in efficacy of medications for physicians, clinicians, and pharmacists. We are suggesting that gold‐standard double‐blind clinical studies should be conducted to determine the best time of day for optimal effectiveness of medications; also, we suggest that time of day should be tracked and reported as an important biological variable in ongoing clinical studies hereafter. Furthermore, we emphasize that time of day is, and should be considered, a key biological variable in research design similar to sex. In common with biomedical research data that have been historically strongly skewed toward the male sex, most pharmaceutical data have been skewed toward morning dosing without strong evidence that this is the optimal time of efficacy.

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Section: Rheumatoid Arthritismentioning

confidence: 99%

Section: Immune Systemmentioning

confidence: 99%

Circadian Variation in Efficacy of Medications

Walton

Walker

Bumgarner

et al. 2020

Clin Pharma and Therapeutics

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Clinical trial evidence of quality-of-life effects of disease-modifying therapies for multiple sclerosis: a systematic analysis

Hirt,

Dembowska,

Woelfle

et al. 2024

J Neurol

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Background Increasingly, patients, clinicians, and regulators call for more evidence on the impact of innovative medicines on quality of life (QoL). We assessed the effects of disease-modifying therapies (DMTs) on QoL in people with multiple sclerosis (PwMS). Methods Randomized trials assessing approved DMTs in PwMS with results for at least one outcome referred to as “quality of life” were searched in PubMed and ClinicalTrials.gov. Results We identified 38 trials published between 1999 and 2023 with a median of 531 participants (interquartile range (IQR) 202 to 941; total 23,225). The evaluated DMTs were mostly interferon-beta (n = 10; 26%), fingolimod (n = 7; 18%), natalizumab (n = 5; 13%), and glatiramer acetate (n = 4; 11%). The 38 trials used 18 different QoL instruments, with up to 11 QoL subscale measures per trial (median 2; IQR 1–3). QoL was never the single primary outcome. We identified quantitative QoL results in 24 trials (63%), and narrative statements in 15 trials (39%). In 16 trials (42%), at least one of the multiple QoL results was statistically significant. The effect sizes of the significant quantitative QoL results were large (median Cohen’s d 1.02; IQR 0.3–1.7; median Hedges’ g 1.01; IQR 0.3–1.69) and ranged between d 0.14 and 2.91. Conclusions Certain DMTs have the potential to positively impact QoL of PwMS, and the assessment and reporting of QoL is suboptimal with a multitude of diverse instruments being used. There is an urgent need that design and reporting of clinical trials reflect the critical importance of QoL for PwMS.

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Factors Associated with Medicine Timing Effects: A Meta-analysis

Ruben

Francey

et al. 2021

Preprint

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Importance Clinical evidence suggests that the time of day of treatment can affect outcomes in many different diseases, but this information is dispersed, imprecise, and heterogeneous. Consequently, practice guidelines and clinical care recommendations seldom specify intervention time. Objective To understand the sources of variability and summarize clinical findings on the time of day effects of medicine. Data Sources A systematic search of Pubmed, Google Scholar, and ClinicalTrials.gov for chronotherapy OR time of administration. Study Selection Any clinical study since 2000, randomized or observational, that compared the effects of treatment at different times of day. We included pharmacologic or surgical interventions having at least one continuous outcome. Data Extraction and Synthesis For selected studies, we extracted the mean and variance of each time-of-day treatment group. From these, we computed the standardized mean difference (SMD) as the measure of timing effect. Where a study reported multiple outcomes, we selected a single outcome based on a defined order of priority. Main Outcomes and Measures We estimated overall pooled effect size and heterogeneity by a random effects model, followed by outlier detection and subgroup analyses to evaluate how study factors, including drug, design, outcome, and source, associate with timing effect. Results 78 studies met the inclusion criteria, comprising 48 distinct interventions over many therapeutic areas. We found an overall effect of time on clinical outcomes but with substantial heterogeneity between studies. Predicted effects range from none to large depending on the study context. Study size, registration status, and source are associated with the magnitude of effect. Larger trials and those that were pre-registered have markedly smaller effects, suggesting that the published record overstates the effects of the timing of medicine on clinical outcomes. In particular, the notion that antihypertensives are more effective if taken at bedtime draws disproportionately from one source in the field, which consistently detects larger effects than the community average. Lastly, among the most highly studied drug timing relationships, the aspirin anti-clotting effect stands out, consistently favoring evening over morning dosing. Conclusions and Relevance While accounts of drug timing effects have focused on yes/no, appreciating the range of probable effects may help clarify where circadian medicine meets the threshold for clinical benefit.

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Administration of subcutaneous interferon beta 1a in the evening: data from RELIEF study

Cited by 5 publications

References 27 publications

Circadian Variation in Efficacy of Medications

Circadian Variation in Efficacy of Medications

Clinical trial evidence of quality-of-life effects of disease-modifying therapies for multiple sclerosis: a systematic analysis

Factors Associated with Medicine Timing Effects: A Meta-analysis

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