scholarly journals Impact of Galcanezumab on Total Pain Burden: Findings From Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies in Patients with Episodic or Chronic Migraine (EVOLVE-1, EVOLVE-2, and REGAIN Trials)

2020 ◽  
Author(s):  
Jessica Ailani ◽  
J Scott Andrews ◽  
Mallikarjuna Rettiganti ◽  
Robert A Nicholson
Keyword(s):  
Chronic Migraine ◽  
Repeated Measures ◽  
Migraine Headache ◽  
Pain Severity ◽  
Life Questionnaire ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Total Pain ◽  
Maximum Pain ◽  
The Impact

Abstract BACKGROUND: Focus on the frequency of migraine pain may undervalue the total burden of migraine as pain duration and severity may present unique, additive burden. A composite measure of total pain burden (TPB; frequency, severity, and duration) may provide a more comprehensive characterization of pain burden and treatment response in patients with episodic migraine (EM) or chronic migraine (CM). The impact of galcanezumab versus placebo on TPB among patients with EM or CM was analyzed.METHODS: Patients from randomized, double-blind, placebo-controlled episodic (two 6‑month studies pooled) and chronic migraine (3-month) studies received once-monthly subcutaneous injection of galcanezumab 120 mg or placebo. A post hoc analysis of TPB for a given month was calculated as severity-weighted duration by multiplying duration (hours) and maximum pain severity (0=none, 1=mild, 2=moderate, 3=severe) of migraine for each day and summing these over the days in a month. Least square mean change from baseline in monthly TPB across Months 1-6 (EM, N=444 galcanezumab, N=894 placebo) and Months 1‑3 (CM, N=278 galcanezumab, N=558 placebo) were compared using a mixed-model repeated measures model. Correlation of the Migraine Specific Quality of Life Questionnaire (MSQ) and Migraine Disability Assessment Scale (MIDAS) to TPB at baseline was assessed.RESULTS: At baseline, the duration of migraine on a given migraine headache day accounted for the greatest unique proportion of variability (EM, 57.4% and CM, 61.1%) to TPB after adjusting for frequency of migraine headache days and maximum pain severity. The decrease from baseline in monthly TPB was greater with galcanezumab than placebo for patients with EM (68.6 versus 36.2) and CM (102.6 versus 44.4). The average percent reduction of TPB from baseline was significantly greater with galcanezumab compared with placebo in patients with EM (50.8% versus 17.2%) and CM (29.7% versus 11.0%). In patients with EM and CM, TPB correlated with MSQ total score (r=‑0.35 and r=‑0.37) and MIDAS (r=0.34 and r=0.32).CONCLUSIONS: Greater reduction in TPB was seen in patients with EM and CM treated with galcanezumab 120 mg once-monthly injection relative to placebo. Discussing TPB supports patient-centric conversations regarding treatment expectations when clinicians are evaluating options for migraine prevention.TRIAL REGISTRATION: ClinicalTrials.gov: #NCT02614183 (I5Q-MC-CGAG; EVOLVE-1), #NCT02614196 (I5Q‑MC‑CGAH; EVOLVE-2), and #NCT02614261 (I5Q-MC-CGAI; REGAIN) – all 3 trials were registered on 23 November 2015.

scholarly journals Impact of galcanezumab on total pain burden: findings from phase 3 randomized, double-blind, placebo-controlled studies in patients with episodic or chronic migraine (EVOLVE-1, EVOLVE-2, and REGAIN trials)

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Jessica Ailani ◽  
J. Scott Andrews ◽  
Mallikarjuna Rettiganti ◽  
Robert A. Nicholson
Keyword(s):  
Chronic Migraine ◽  
Migraine Headache ◽  
Pain Severity ◽  
Life Questionnaire ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Link Type ◽  
Total Pain ◽  
Maximum Pain ◽  
The Impact

Abstract Background Focus on the frequency of migraine pain may undervalue the total burden of migraine as pain duration and severity may present unique, additive burden. A composite measure of total pain burden (TPB; frequency, severity, and duration) may provide a more comprehensive characterization of pain burden and treatment response in patients with episodic migraine (EM) or chronic migraine (CM). The impact of galcanezumab versus placebo on TPB among patients with EM or CM was analyzed. Methods Patients from randomized, double-blind, placebo-controlled episodic (two 6-month studies pooled) and chronic migraine (3-month) studies received once-monthly subcutaneous injection of galcanezumab 120 mg or placebo. A post hoc analysis of TPB for a given month was calculated as severity-weighted duration by multiplying duration (hours) and maximum pain severity (0 = none, 1 = mild, 2 = moderate, 3 = severe) of migraine for each day and summing these over the days in a month. Least square mean change from baseline in monthly TPB across Months 1–6 (EM, N = 444 galcanezumab, N = 894 placebo) and Months 1–3 (CM, N = 278 galcanezumab, N = 558 placebo) were compared using a mixed-model repeated measures model. Correlation of the Migraine Specific Quality of Life Questionnaire (MSQ) and Migraine Disability Assessment Scale (MIDAS) to TPB at baseline was assessed. Results At baseline, the duration of migraine on a given migraine headache day accounted for the greatest unique proportion of variability (EM, 57.4% and CM, 61.1%) to TPB after adjusting for frequency of migraine headache days and maximum pain severity. The decrease from baseline in monthly TPB was greater with galcanezumab than placebo for patients with EM (68.6 versus 36.2) and CM (102.6 versus 44.4). The average percent reduction of TPB from baseline was significantly greater with galcanezumab compared with placebo in patients with EM (50.8% versus 17.2%) and CM (29.7% versus 11.0%). In patients with EM and CM, TPB correlated with MSQ total score (r = − 0.35 and r = − 0.37) and MIDAS (r = 0.34 and r = 0.32). Conclusions Greater reduction in TPB was seen in patients with EM and CM treated with galcanezumab 120 mg once-monthly injection relative to placebo. Discussing TPB supports patient-centric conversations regarding treatment expectations when clinicians are evaluating options for migraine prevention. Trial registration ClinicalTrials.gov: #NCT02614183 (I5Q-MC-CGAG; EVOLVE-1), #NCT02614196 (I5Q-MC-CGAH; EVOLVE-2), and #NCT02614261 (I5Q-MC-CGAI; REGAIN) – all 3 trials were registered on 23 November 2015.

scholarly journals Impact of Galcanezumab on Total Pain Burden: Findings From Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies in Patients with Episodic or Chronic Migraine (EVOLVE-1, EVOLVE-2, and REGAIN Trials)

2020 ◽  
Author(s):  
Jessica Ailani ◽  
J Scott Andrews ◽  
Mallikarjuna Rettiganti ◽  
Robert A Nicholson
Keyword(s):  
Chronic Migraine ◽  
Migraine Headache ◽  
Pain Severity ◽  
Life Questionnaire ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Total Pain ◽  
Monthly Injection ◽  
Maximum Pain ◽  
The Impact

Abstract BACKGROUND Focus on the frequency of migraine pain may undervalue the total burden of migraine as pain duration and severity may present unique, additive burden. A composite measure of total pain burden (TPB; frequency, severity, and duration) of migraine may provide a more comprehensive characterization of pain burden and treatment response in patients with episodic migraine (EM) or chronic migraine (CM). The impact of galcanezumab 120 mg once-monthly injection versus placebo on TPB among patients with EM or CM was analyzed. METHODS Patients from randomized, double-blind, placebo-controlled episodic (6-month) and chronic migraine (3-month) studies received once-monthly subcutaneous injection of galcanezumab 120 mg once-monthly or placebo. Total pain burden for a given month was calculated as severity-weighted duration by multiplying duration (hours) and maximum pain severity (0 = none, 1 = mild, 2 = moderate, 3 = severe) of migraine for each day and summing these over the days in a month. Least square (LS) mean change from baseline in monthly TPB across Months 1–6 (EM) and Months 13 (CM) were compared post hoc using a mixed-model repeated measures model. Correlation of the Migraine Specific Quality of Life Questionnaire (MSQ) and Migraine Disability Assessment Scale (MIDAS) to TPB at baseline was assessed. RESULTS At baseline, the duration of migraine on a given migraine headache day accounted for the greatest unique proportion of variability (EM, 57.4% and CM, 61.1%) to the TPB after adjusting for frequency of migraine headache days and maximum pain severity. The LS mean decreases from baseline in monthly TPB across months were greater with galcanezumab than placebo for patients with EM (68.6 versus 36.2) and CM (102.6 versus 44.4). The average percent reduction of TPB from baseline was significantly greater with galcanezumab compared with placebo in patients with EM (50.8% versus 17.2%) and CM (29.7% versus 11.0%). Total pain burden in patients with EM and CM correlated with MSQ total score (r = 0.35 and r=-0.37) and MIDAS (r = 0.34 and r = 0.32). CONCLUSIONS Greater reduction in TPB was seen in patients with EM and CM treated with galcanezumab 120 mg once-monthly injection relative to placebo. Discussing TPB supports patient-centric conversations regarding treatment expectations when clinicians are evaluating options for migraine prevention. TRIAL REGISTRATION: ClinicalTrials.gov: #NCT02614183 (I5Q-MC-CGAG; EVOLVE-1), #NCT02614196 (I5QMCCGAH; EVOLVE-2), and #NCT02614261 (I5Q-MC-CGAI; REGAIN) – all 3 trials were registered on 23 November 2015.

scholarly journals Changes in patient functioning and disability: results from a phase 3, double-blind, randomized, placebo-controlled clinical trial evaluating galcanezumab for chronic migraine prevention (REGAIN)

2020 ◽  
Author(s):  
Janet Ford ◽  
Cristina Tassorelli ◽  
Elizabeth Leroux ◽  
Shufang Wang ◽  
David Ayer ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Repeated Measures ◽  
Mixed Model ◽  
Analysis Of Covariance ◽  
Controlled Clinical Trial ◽  
Life Questionnaire ◽  
Open Label ◽  
Double Blind ◽  
Patient Functioning ◽  
The Impact

Abstract Purpose To evaluate secondary outcomes including changes in functioning and disability associated with galcanezumab, a humanized monoclonal antibody to calcitonin gene-related peptide, in patients with chronic migraine. Methods Patients randomly received galcanezumab (120 mg n = 278, 240 mg n = 277) or placebo (n = 558) during 3 months of double-blind treatment, followed by a 9-month open-label extension. The Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQv2.1) measured the impact of migraine on patient functioning. The Migraine Disability Assessment (MIDAS) quantified headache-related disability. Changes from baseline were analyzed with mixed model repeated measures or analysis of covariance. Results Total MSQ score at baseline was 44.88 ± 18.02 (mean ± SD), indicating significant functional impairment. At Month 3, least squares (LS) mean change ± SE in total MSQ for galcanezumab-treated patients were 20.51 ± 1.49 (120 mg) and 20.49 ± 1.49 (240 mg), both statistically significantly greater vs placebo-treated patients (14.55 ± 1.21; both P < 0.001). Total MIDAS score at baseline was 67.24 ± 57.31 (mean ± SD). At Month 3, LS mean change ± SE from baseline in total MIDAS for galcanezumab-treated patients was statistically significantly greater than placebo for 120 mg group (placebo: − 11.53 ± 3.38 vs 120 mg: − 20.27 ± 4.07; P < 0.05) but not for 240 mg group (− 17.02 ± 4.05). At Month 12, within-group mean changes from baseline for total MSQ (28.56 ± 1.19 previous placebo; 29.53 ± 1.51 previous 120 mg; 25.83 ± 1.49 previous 240 mg) and MIDAS scores (− 28.47 ± 2.95 previous placebo; − 31.47 ± 3.69 previous 120 mg; − 31.13 ± 3.62 previous 240 mg) were statistically significant (P < 0.001) for the open-label treatment population regardless of previous double-blind treatment assignment. Conclusions Galcanezumab-treated patients with chronic migraine reported statistically significant improvements in functioning and disability, representing a clinically significant change. Trial registration ClinicalTrials.gov registry: NCT02614261. Registered 25 November 2015.

Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure

Cephalalgia ◽  
2019 ◽  
Vol 39 (8) ◽  
pp. 931-944 ◽  
Author(s):  
Dustin D Ruff ◽  
Janet H Ford ◽  
Antje Tockhorn-Heidenreich ◽  
Matthew Sexson ◽  
Sriram Govindan ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Migraine Headache ◽  
Medication Use ◽  
Domain Score ◽  
Controlled Study ◽  
Life Questionnaire ◽  
Phase 3 ◽  
Double Blind ◽  
Acute Medication ◽  
R Domain

Background Efficacy of galcanezumab in chronic migraine has been demonstrated in a pivotal Phase 3 study. Here, we assess efficacy in patients who have failed ≥2 and ≥1 prior migraine preventives for efficacy and/or safety reasons, and in those who never failed. Study design/methods REGAIN (NCT02614261) was a Phase 3, randomized, double-blind, placebo-controlled study in patients with chronic migraine. Patients were randomized 2:1:1 to receive placebo, galcanezumab 120 mg/240 mg once monthly during a double-blind treatment period lasting three months. Subgroup analyses were conducted among patients who failed ≥2 and ≥1 prior preventives and who never failed previously. Outcomes assessed were change from baseline in number of monthly migraine headache days, proportion of patients with ≥50% and ≥75% response (reduction in monthly migraine headache days), change in number of monthly migraine headache days with acute medication use and change in patient functioning per Migraine-Specific Quality of Life Questionnaire Role Function Restrictive (MSQ RF-R) domain score. Results Treatment with galcanezumab versus placebo resulted in significant improvements ( p < 0.01) in overall reduction (Months 1–3) from baseline in the number of monthly migraine headache days in patients with prior failures (LS mean change [SE]: ≥2 prior failures: galcanezumab 120 mg: −5.35 (0.71); galcanezumab 240 mg: −2.77 (0.66); placebo: −1.01 (0.54); ≥1 prior failures: galcanezumab 120 mg: −5.53 (0.60), galcanezumab 240 mg: −3.53 (0.59); placebo: −2.02 (0.49). Similarly, significant results were seen with galcanezumab versus placebo for ≥50% and ≥75% response rates, reductions in acute medication use and improvements in MSQ RF-R domain score. In the subgroup with no prior preventive failures, results were statistically significant for the 240 mg galcanezumab group versus placebo on all outcome measures, and for the 120 mg group on the reduction in migraine headache days with acute medication use. There was also a higher placebo response observed in the patients with no prior preventive failures. Conclusion Galcanezumab is consistently efficacious versus placebo in reducing monthly migraine headache days and several other key outcomes in patients with chronic migraine who have failed ≥2 or ≥1 preventives previously. In the subgroup with no prior failures, greater numerical differences were seen with galcanezumab, but statistical separation from placebo varied by dose and outcome. Clinicaltrials.gov identifier number NCT02614261.

Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine

Cephalalgia ◽  
2020 ◽  
pp. 033310242096665
Author(s):  
David W Dodick ◽  
Erin G Doty ◽  
Sheena K Aurora ◽  
Dustin D Ruff ◽  
Virginia L Stauffer ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Subgroup Analysis ◽  
Repeated Measures ◽  
Migraine Headache ◽  
Medication Overuse ◽  
Preventive Treatment ◽  
Episodic Migraine ◽  
Phase 3 ◽  
Double Blind ◽  
Acute Medication

Introduction Acute medication overuse is prevalent in patients with migraine. Methods In three phase 3, double-blind, randomized, placebo-controlled studies, patients with episodic migraine (EVOLVE-1 and EVOLVE-2) or chronic migraine (REGAIN) were randomized 2:1:1 to monthly subcutaneous injections of placebo or galcanezumab 120 or 240 mg for 3 or 6 months. This subgroup analysis evaluated mean changes in the number of monthly migraine headache days in each treatment among patients with versus without baseline acute medication overuse via mixing modelling with repeated measures. Results The percentages of patients with baseline medication overuse in placebo, galcanezumab 120-mg and 240-mg groups, respectively, were 19.4%, 17.3%, and 19.3% for EVOLVE-1/-2 (pooled; post hoc), and 63.4%, 64.3%, and 64.1% for REGAIN ( a priori). Both galcanezumab doses demonstrated significant improvement compared with placebo for overall least squares mean change in monthly migraine headache days in patients with baseline medication overuse in both the episodic and chronic migraine studies ( p ≤ 0.001). Furthermore, both galcanezumab doses reduced average monthly medication overuse rates compared to placebo ( p < 0.001) in both patient populations with medication overuse at baseline. Conclusions Galcanezumab appears to be effective for the preventive treatment of episodic and chronic migraine in patients who overuse acute medications. Trial registration: ClinicalTrials.gov Identifiers: NCT02614183, NCT02614196, and NCT02614261

scholarly journals Efficacy of galcanezumab in patients with migraine who did not benefit from commonly prescribed preventive treatments

BMC Neurology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Dulanji K. Kuruppu ◽  
Joshua Tobin ◽  
Yan Dong ◽  
Sheena K. Aurora ◽  
Laura Yunes-Medina ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Migraine Headache ◽  
Mixed Model ◽  
Preventive Treatment ◽  
Response Rates ◽  
Toxin A ◽  
Double Blind ◽  
Preventive Medication ◽  
Onabotulinum Toxin A ◽  
Post Hoc

Abstract Background Galcanezumab is a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) indicated for the preventive treatment of migraine. While galcanezumab has demonstrated efficacy in patients who did not respond to prior preventive medications in general, its efficacy in patients who did not benefit from individual, commonly prescribed preventive treatments due to inadequate efficacy or safety/tolerability remains unknown. Methods CONQUER was a 3-month, randomized, double-blind, placebo-controlled, phase 3b study that enrolled patients with episodic or chronic migraine who had 2 to 4 migraine preventive medication category failures in the past 10 years. Patients were randomly assigned 1:1 to receive placebo (N = 230) or galcanezumab 120 mg/month (240 mg loading dose; N = 232). Post hoc analyses were conducted to determine the efficacy of galcanezumab in patients who had not benefited from six of the most commonly prescribed migraine preventive medications. The mean change from baseline in monthly migraine headache days and ≥ 50 % response rates were assessed over months 1–3. Improvement in Migraine-Specific Questionnaire Role Function-Restrictive (MSQ-RFR) scores were assessed at month 3. The endpoints were estimated via mixed model with repeated measures. Results The most common treatment failures due to inadequate efficacy or safety/tolerability, which at least 20 % of patients reported trying without benefit, included topiramate, amitriptyline, propranolol, valproate or divalproex, onabotulinum toxin A, and metoprolol. Patients who had not previously benefited from these treatments had a greater mean reduction in monthly migraine headache days across months 1–3 in the galcanezumab group compared to placebo (all p < 0.01). More patients treated with galcanezumab experienced a ≥ 50 % reduction from baseline in monthly migraine headache days across months 1–3 compared to placebo (all p < 0.05). Galcanezumab-treated patients had a greater improvement in mean MSQ-RFR scores at month 3 compared to placebo (all p < 0.01). Conclusions In this population, galcanezumab was effective in reducing monthly migraine headache days, improving response rates, and enhancing quality of life in patients who had not previously benefited from topiramate, amitriptyline, propranolol, valproate or divalproex, onabotulinum toxin A, and/or metoprolol due to inadequate efficacy or safety/tolerability. Trial registration ClinicalTrials.gov NCT03559257 (CONQUER).

scholarly journals Effect of galcanezumab on severity and symptoms of migraine in phase 3 trials in patients with episodic or chronic migraine

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Michael Ament ◽  
Kathleen Day ◽  
Virginia L Stauffer ◽  
Vladimir Skljarevski ◽  
Mallikarjuna Rettiganti ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Migraine Headache ◽  
Randomized Clinical Trials ◽  
Episodic Migraine ◽  
Double Blind Study ◽  
Double Blind ◽  
Prodromal Symptoms ◽  
Link Type ◽  
Associated Symptoms ◽  
Severe Migraine

Abstract Background Galcanezumab, a humanized monoclonal antibody that binds calcitonin gene-related peptide, has demonstrated a significant reduction in monthly migraine headache days compared with placebo. Here, we analyze data from 3 randomized clinical trials (2 episodic trials [EVOLVE-1, EVOLVE-2] and 1 chronic trial [REGAIN]), to examine if galcanezumab also alleviates the severity and symptoms of migraine. Methods The episodic migraine trials were 6-month, double-blind studies in patients with episodic migraine (4–14 monthly migraine headache days). The chronic migraine trial was a 3-month, double-blind study in patients with chronic migraine (≥ 15 headache days per month, where ≥ 8 met criteria for migraine). Patients (18–65 years) were randomized to placebo or galcanezumab 120 mg with a 240-mg loading dose or 240 mg. Patients recorded headache characteristics, duration, severity, and presence of associated symptoms with each headache. The outcomes analyzed were changes from baseline in number of monthly migraine headache days with nausea and/or vomiting, photophobia and phonophobia, aura, and prodromal symptoms other than aura. Additional outcomes analyzed included the number of moderate-to-severe monthly migraine headache days, number of severe migraine headache days, and mean severity of remaining migraine headache days. Change from baseline in the proportion of days with nausea and/or vomiting and the proportion of days with photophobia and phonophobia among the remaining monthly migraine headache days were also analyzed. Results Galcanezumab was superior to placebo in reducing the frequency of migraine headache days with associated symptoms of migraine such as nausea and/or vomiting, photophobia and phonophobia, and prodromal symptoms. Galcanezumab reduced the frequency of migraine headache days with aura in the episodic migraine studies. There was a significant reduction in the proportion of remaining migraine headache days with nausea and/or vomiting for the episodic and chronic migraine studies, and with photophobia and phonophobia for the episodic migraine studies. Galcanezumab was superior to placebo in reducing the number of monthly moderate-to-severe migraine headache days and the overall and monthly severe migraine headache days. Conclusions Galcanezumab reduces the frequency of migraine headache days and can alleviate potentially disabling non-pain symptoms on days when migraine is present in patients with episodic or chronic migraine. Trial registration NCT, NCT02614183 (EVOLVE-1), registered 25 November 2015; NCT, NCT02614196, (EVOLVE-2), registered 25 November 2015; NCT, NCT02614261 (REGAIN), registered 25 November 2015.

scholarly journals Intralymphatic immunotherapy with tyrosine-adsorbed allergens: a double-blind, placebo-controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Hye Jung Park ◽  
Sae-Hoon Kim ◽  
Yoo Seob Shin ◽  
Chul Hwan Park ◽  
Eun-Suk Cho ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Injection Site ◽  
Symptom Score ◽  
Therapeutic Efficacy ◽  
Controlled Trial ◽  
Life Questionnaire ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Medication Score ◽  
Allergen Extracts

Abstract Background Most previous studies used aluminum hydroxide-absorbed allergen extracts in evaluating the potential therapeutic roles of intralymphatic allergen-specific immunotherapy (ILAIT). In this study, we evaluated the therapeutic efficacy and safety of ILAIT with L-tyrosine-adsorbed allergen extracts of Dermatophagoides farinae, D. pteronyssinus, cat, dog, or mixtures thereof, in patients with allergic rhinitis induced by these allergens. Methods In this randomized, double-blind, placebo-controlled trial, study subjects received three intralymphatic injections of L-tyrosine-adsorbed allergen extracts (active group) or saline (placebo group) at 4-week intervals. Results Although ILAIT reduced daily medication use and skin reactivity to HDM and cat allergens at 4 months after treatment, overall symptom score on a visual analog scale (VAS), sinonasal outcome test-20 (SNOT-20), rhinoconjunctivitis quality of life questionnaire (RQLQ), daily symptom score (dSS), daily medication score (dMS), daily symptom medication score (dSMS), nasal reactivity to HDM allergen, and basophil activity to HDM, cat, and dog allergens at 4 months and 1 year after treatment were similar between the treatment and control groups. Intralymphatic injection was more painful than a venous puncture, and pain at the injection site was the most frequent local adverse event (12.8%); dyspnea and wheezing were the most common systemic adverse events (5.3%). Conclusions ILAIT with L-tyrosine-adsorbed allergen extracts does not exhibit profound therapeutic efficacy in allergic rhinitis and can provoke moderate-to-severe systemic reactions and cause pain at the injection site. Trial registration: clinicaltrials.gov: NCT02665754; date of registration: 28 January 2016

scholarly journals Impact of maternal supplementation with probiotics during pregnancy on atopic eczema in childhood – a meta-analysis

2011 ◽  
Vol 107 (1) ◽  
pp. 1-6 ◽  
Author(s):  
Katja Doege ◽  
Donata Grajecki ◽  
Birgit-Christiane Zyriax ◽  
Elena Detinkina ◽  
Christine zu Eulenburg ◽  
...  
Keyword(s):  
Atopic Eczema ◽  
Data Extraction ◽  
Meta Analysis ◽  
Significant Risk ◽  
Controlled Trials ◽  
Bacterial Strains ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Study Selection ◽  
The Impact

In the present study, we sought to conduct a literature review of randomised, double-blind, placebo-controlled trials, which assessed the impact of probiotics intake during pregnancy on the development of eczema in children. A meta-analysis was conducted for comparison of the development of atopic eczema in children whose mothers took probiotics during pregnancyv.placebo. Study selection, quality appraisal and data extraction were performed independently and in duplicate. The studies were rated according to their size in order to calculate the influence of individual studies on the meta-analysis. A total of seven randomised, double-blind, placebo-controlled trials, published between 2001 and 2009, were selected from the PubMed and Ovid databases for the meta-analysis. The meta-analysis was performed with statistical software Stata/SE11.0. The completed meta-analysis of the seven studies shows a significant risk reduction for atopic eczema in children aged 2–7 years by the administration of probiotics during pregnancy (reduction 5·7 %;P = 0·022). However, this effect was only significant for lactobacilli (reduction 10·6 %;P = 0·045), but not for a mixture of various bacterial strains as probiotics (difference 3·06 %,P = 0·204). In conclusion, the meta-analysis shows that the administration of lactobacilli during pregnancy prevents atopic eczema in children aged from 2 to 7 years. However, a mixture of various bacterial strains does not affect the development of atopic eczema, independent of whether they contain lactobacilli or not.

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