Real-world safety and efficacy of omalizumab in patients with severe allergic asthma: A long-term post-marketing study in Japan

Adachi, Mitsuru; Kozawa, Masanari; Yoshisue, Hajime; Milligan, Ki Lee; Nagasaki, Makoto; Sasajima, Takayoshi; Miyamoto, Terumasa; Ohta, Ken

doi:10.1016/j.rmed.2018.06.021

Cited by 68 publications

(50 citation statements)

References 71 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…17,20,22,23 Real-world studies also reported a reduction in the need for oral corticosteroid (OCS) therapy with omalizumab treatment in patients with moderate to severe allergic asthma. [17][18][19][20][21]24,25,27 A systematic review of 24 realworld studies (N=4117) conducted across 32 countries on the short-and long-term effects of omalizumab in the treatment of severe allergic asthma confirms the abovementioned benefits. 28 To date, there is limited real-world evidence on Canadian asthma patients receiving omalizumab.…”

Section: Introductionmentioning

confidence: 72%

“…The authors also noted that treatment with omalizumab versus placebo improved asthma symptom scores and quality of life in both steroid-stable and steroid-reduction phases. 2 The results of real-world studies conducted in patients with moderate to severe allergic asthma in Canada, 17 Japan, 18 Israel, 19 and Europe [20][21][22][23][24][25][26][27] corroborate the favorable findings of clinical trials and confirm the effectiveness of omalizumab in reducing exacerbations, 17,18,20,[22][23][24][25][26][27] emergency room visits, 19,23 hospitalizations 24 and improving asthma symptoms and control, 17,22,23,25,26 and quality of life. 17,20,22,23 Real-world studies also reported a reduction in the need for oral corticosteroid (OCS) therapy with omalizumab treatment in patients with moderate to severe allergic asthma.…”

Section: Introductionmentioning

confidence: 80%

See 1 more Smart Citation

<p>Real-World Observational Study on the Characteristics and Treatment Patterns of Allergic Asthma Patients Receiving Omalizumab in Canada</p>

Lee¹,

Amin²,

Erdmann³

et al. 2020

PPA

View full text Add to dashboard Cite

Background: Omalizumab is a treatment option for pediatric and adult patients with moderate to severe allergic asthma poorly controlled with standard inhaled therapies. Clinical trials and observational studies have demonstrated the efficacy of omalizumab. There is limited real-world evidence on the characteristics and treatment patterns of Canadian asthma patients receiving omalizumab. Objective: We profiled Canadian omalizumab users to estimate time to omalizumab discontinuation and to assess changes in concurrent medication usage before, during, and after therapy. Methods: This was a retrospective, observational, cohort study that analyzed data from Canadian prescription claims databases. An algorithm was used to select naïve users of omalizumab with an inferred diagnosis of GINA 5-asthma who made a claim for omalizumab from February 1, 2007, to June 2, 2015. Demographic and baseline characteristics were assessed at index. Outcomes examined over the analysis period included (i) daily omalizumab dose per patient and per claim; (ii) omalizumab discontinuation (defined as ≥100-day gap in making omalizumab claims) and its potential predictors (ie, age, sex, province of residence, drug insurer; assessed by Cox Proportional Hazards Model); and (iii) for patients who discontinued omalizumab, changes in concurrent medication usage before, during, and 6 months after omalizumab usage. Results: The final study cohort consisted of 1160 patients (mean age: 45.8 ± 15.2 years; 64.7% female). During the first year of omalizumab therapy, 29.5% of patients discontinued treatment. The singular characteristic that predicted omalizumab discontinuation with statistical significance was age group (20-34 years vs 12-19 years; hazard ratio 1.75, 95% confidence interval 1.11-2.76; P<0.05). There were significant reductions in the use of some concurrent inhaled and oral asthma medications during and/or after omalizumab use (P<0.05). Conclusion: Nearly one-third of patients who initiated omalizumab in Canada for refractory, moderate to severe allergic asthma discontinued treatment during the first year.

show abstract

Section: Introductionmentioning

confidence: 72%

Section: Introductionmentioning

confidence: 80%

<p>Real-World Observational Study on the Characteristics and Treatment Patterns of Allergic Asthma Patients Receiving Omalizumab in Canada</p>

Lee¹,

Amin²,

Erdmann³

et al. 2020

PPA

View full text Add to dashboard Cite

show abstract

“…However, the population demographics of that study differed with respect to age and gender: elevated mean age (59.3 years) with 44% of patients aged >65 years, and more female patients (64.5%). 23 A comprehensive look at asthma control (which was out of scope for this analysis) considers reducing symptoms, airflow limitation, and exacerbation risks by optimizing inhaler techniques, trigger avoidance, adherence, perception of disease, and appropriateness of therapy versus need for escalation. 24 In the current study, due to its retrospective design using the secondary database, data on above clinical outcomes (e.g., symptoms, lung function) could not be collected, and therefore step-up in therapy offers a reasonable, though incomplete, surrogate measure for loss of disease control in patients in the non-severe asthma cohort.…”

Section: Discussionmentioning

confidence: 99%

A retrospective cohort study evaluating healthcare resource utilization in patients with asthma in Japan

Inoue

Kozawa

Milligan

et al. 2019

npj Prim. Care Respir. Med.

Self Cite

View full text Add to dashboard Cite

Although the global economic burden of asthma is well described, detailed data regarding Asia, particularly for Japan, are relatively scarce. This retrospective study aims to fill this evidence gap by evaluating asthma-associated healthcare resource utilization (HCRU) and economic burden in Japanese patients aged ≥16 years, identified using anonymized patient data from the Japan Medical Data Center (JMDC) database from April 2009 to March 2015. Asthma severity was classified according to asthma treatment guidelines from the Japanese Society of Allergology. HCRU was calculated based on hospitalizations, emergency room visits, outpatient visits, and prescriptions. Incidence rate ratios (IRRs) for HCRU and per-patient-per-year direct costs were reported. In addition, differences across HCRU and cost variables for severe versus non-severe asthma patients were also compared. Of 541,434 asthma cases identified from the JMDC database during the study period, 54,433 patients who met the inclusion criteria were included in this analysis. HCRU and costs were heavily concentrated within severe asthma, a subgroup comprising 12.7% of total study population. Moreover, patients with severe asthma had significantly higher all-cause hospitalizations, outpatient visits, outpatient prescriptions (IRR [95% CI], 1.60 [1.46–1.76]; 1.43 [1.41–1.45]; 1.24 [1.22–1.25], respectively), and total medical costs (mean ± SD costs, US$ 4345 ± 11,104 versus US$ 1528 ± 3989, P < 0.001 ( t -test); US$ 1 = 110 JPY) compared with those with non-severe asthma. The burden of asthma is significantly and disproportionately concentrated in Japanese severe asthma patients, suggesting clinical failure to achieve adequate disease control. This study highlights the unmet needs for severe asthma in Japan and provides a catalyst for important dialogues in advancing public health.

show abstract

“…To minimize bias, non-significant results reported in the original publication were included in our pooled estimates. Table 1 summarizes the 42 studies stratified by 30 adult-only studies [24,26,27,[30][31][32][33][34][35][36][37][40][41][42][43][44][45][46][47][58][59][60][61][62][63][64][65][66][67][68] (n = 3558) and 12 adult/ adolescent studies [25,38,39,56,57,[69][70][71][72][73][74][75][76][77] (n = 5819). These 42 studies comprised a total of 9377 patients from 35 countries: 25 in Europe (incl.…”

Section: Other Methodological Considerationsmentioning

confidence: 99%

Short- and long-term real-world effectiveness of omalizumab in severe allergic asthma: systematic review of 42 studies published 2008-2018

MacDonald

Kavati

Ortiz

et al. 2019

Expert Review of Clinical Immunology

View full text Add to dashboard Cite

Introduction: Omalizumab is a recombinant monoclonal anti-IgE antibody approved in the US as add-on treatment in moderate-to-severe allergic asthma (in severe allergic asthma [SAA] in Europe). A 2016 review of 24 real-world effectiveness studies in SAA published between 2008-2015 concluded that omalizumab was associated with significant improvements in objective and subjective outcomes with benefits extending beyond 2 years. Several new real-world studies have been published since, bringing the total to 42 studies. Areas covered: This systematic review of 42 studies published since 2008 updates and extends the 2016 review on the real-word evidence on omalizumab in SAA. It offers greater granularity as to time windows within which outcomes are reported and includes studies extending well beyond 4 years post omalizumab initiation. Expert commentary: This review firmly establishes the short-term effectiveness of omalizumab in adolescent and adult patients with SAA at 1 year, and provides strong evidence of long-term effectiveness up to 4 years and emergent evidence of effectiveness beyond 4 years. In the aggregate, these 42 studies underscore the long-term effectiveness of omalizumab in terms of: reducing exacerbations and symptoms, achieving asthma control, improving lung function, enhancing quality of life, decreasing emergency department visits and hospitalizations, and promoting concomitant medication-sparing. ARTICLE HISTORY

show abstract

Real-world safety and efficacy of omalizumab in patients with severe allergic asthma: A long-term post-marketing study in Japan

Abstract: This post-marketing study confirmed the clinically meaningful benefits of omalizumab in a majority of patients from Japan, and showed safety and efficacy in a real-life clinical setting to be consistent with previous reports.

Cited by 68 publications

References 71 publications

<p>Real-World Observational Study on the Characteristics and Treatment Patterns of Allergic Asthma Patients Receiving Omalizumab in Canada</p>

<p>Real-World Observational Study on the Characteristics and Treatment Patterns of Allergic Asthma Patients Receiving Omalizumab in Canada</p>

A retrospective cohort study evaluating healthcare resource utilization in patients with asthma in Japan

Short- and long-term real-world effectiveness of omalizumab in severe allergic asthma: systematic review of 42 studies published 2008-2018

Contact Info

Product

Resources

About