Extension of mepolizumab injection intervals as potential of saving costs in well controlled patients with severe eosinophilic asthma

Bölke, Georg; Tong, Xunliang; Zuberbier, Torsten; Bousquet, Jean; Bergmann, Karl‐Christian

doi:10.1016/j.waojou.2022.100703

Cited by 6 publications

(4 citation statements)

References 20 publications

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“…This effect is closely related to the mepolizumab-mediated improvement in asthma control. The results of our study are consistent with those of other studies [16][17][18][19][20]. In this study, we found that mepolizumab did not change IgE levels, which is in agreeance with the results of other studies [21,22].…”

Section: Discussionsupporting

confidence: 93%

Clinical Remission Criteria and Serum Levels of Type 2 Inflammation Mediators during 24 Weeks of Treatment with the Anti-IL-5 Drug Mepolizumab in Patients with T2-High Severe Asthma

Palacionyte,

Januskevicius,

Vasyle

et al. 2024

Diagnostics

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Anti-interleukin (IL) 5 is an effective treatment modality for inhibiting eosinophilic inflammation in patients with T2-high severe asthma. The aim of this study was to determine the clinical efficacy and serum levels of type 2 inflammatory mediators during 24 weeks of mepolizumab treatment in patients with T2-high severe asthma. Eighteen patients with T2-high severe asthma were enrolled in this study. All patients received 100 mg of mepolizumab subcutaneously every 4 weeks and were retested at 4, 12, and 24 weeks. A clinical examination, asthma control test (ACT), and spirometry were performed; fractional exhaled nitric oxide (FeNO) levels were evaluated; and blood samples were drawn at every visit. Type 2 inflammation mediator levels were measured using enzyme-linked immunosorbent assay (ELISA). The blood eosinophil level significantly decreased, the ACT score and FEV1 increased after 4 weeks of mepolizumab treatment with the same tendency after 12 and 24 weeks (p < 0.05), and the FeNO level did not change (p > 0.05). A total of 27.8% of patients reached clinical remission criteria after 24 weeks of mepolizumab treatment. IL-33 and eotaxin significantly increased (p < 0.05) while IL-5, IL-13, thymic stromal lymphopoietin (TSLP), soluble IL-5 receptor subunit alpha (sIL-5Rα), and soluble high-affinity immunoglobulin E receptor (sFcεRI) decreased, with the same tendency after 12 and 24 weeks (p < 0.05). The serum levels of immunoglobulin (Ig) E and IL-4 and IL-25 levels did not change during mepolizumab treatment compared to baseline (p > 0.05). In conclusion, treatment with mepolizumab over 24 weeks improved lung function and asthma control in T2-high severe asthma patients, with nearly one-third achieving clinical remission criteria, and affected the balance of type 2 inflammatory mediators.

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Section: Discussionsupporting

confidence: 93%

Clinical Remission Criteria and Serum Levels of Type 2 Inflammation Mediators during 24 Weeks of Treatment with the Anti-IL-5 Drug Mepolizumab in Patients with T2-High Severe Asthma

Palacionyte,

Januskevicius,

Vasyle

et al. 2024

Diagnostics

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“…Im Fall einer Kontrolle der CRSwNP wäre eine Verlängerung der Biologikaintervalle medizinisch möglich, wird aber wegen der nicht zugelassenen Applikationsintervalle, daher potenziellem Off-Label-Use [ 7 ], nicht empfohlen [ 10 ]. Für das Asthma und die atopische Dermatitis wurde gezeigt, dass eine gute Kontrolle unter der Biologikatherapie mit verlängerten Therapieintervallen erhalten werden kann [ 3 , 4 , 11 ]. Hier stellt sich die Frage, ob die Kontrolle der CRSwNP im Sinne einer weitestgehenden Rückbildung der Polypen und Beschwerden unter Dupilumab erhalten werden kann, wenn die Dupilumab-Intervalle personalisiert auf 4 Wochen, ggf.…”

Section: Empfehlungen Zur Biologikatherapieunclassified

Chronische Rhinosinusitis mit nasalen Polypen – Verlängerung der Dupilumab-Therapieintervalle

Appel,

Lochbaum,

Hoffmann

et al. 2024

HNO

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Zusammenfassung Hintergrund Eine schwere, nicht kontrollierte chronische Rhinosinusitis mit nasalen Polypen (CRSwNP) kann sich unter Dupilumab 300 mg 2‑wöchentlich komplett zurückbilden. Spätestens dann folgt die Frage der Patienten nach einer möglichen Therapiedeeskalation. Eine Beendigung der Antikörpertherapie nach 24 Wochen führte zum Rezidiv, hingegen blieb unter reduzierter Dupilumab-Dosis durch Streckung des Intervalls auf 4 Wochen die Kontrolle erhalten. Eine vom Zulassungstext abweichende Verlängerung der Therapieintervalle wird jedoch aktuell nicht empfohlen. Methoden Es erfolgte eine retrospektive Untersuchung des Verlaufs von 29 Patienten mit schwerer CRSwNP, mit Typ-2-Inflammation assoziierten Komorbiditäten und bestehender Indikation zur Biologikatherapie. Nach Rückbildung der CRSwNP und der Beschwerden unter Dupilumab 300 mg 2‑wöchentlich war das Applikationsintervall individuell zunächst auf 4 Wochen, danach ggf. auf 6 Wochen verlängert worden. Erfasst wurden u. a. die Lebensqualität (Sinonasal Outcome Test, SNOT-22), der nasale Polypenscore (NPS) und das Riechvermögen (Sniffinʼ Sticks, Fa. Burghart Messtechnik, Holm, Deutschland). Ergebnisse Alle Patienten zeigten innerhalb der ersten 3 Monate ein sehr gutes Therapieansprechen. Eine Verlängerung des Dupilumab-Intervalls auf 4 Wochen erfolgte nach 7–31 Monaten (median 13 Monate), auf 6 Wochen (n = 9) nach 17–35 Monaten (median 23 Monate). Im Verlauf traten bei keinem Patienten ein Rezidiv, eine Verschlechterung der Lebensqualität oder des Riechens auf. Schlussfolgerung Eine Verlängerung der Dupilumab-Injektionsintervalle auf 4 evtl. auch 6 Wochen ist individuell nach weitestgehender Rückbildung der Polypen und Beschwerden ohne klinische Verschlechterung möglich. Weitere Studien zur Deeskalation bzw. Beendigung der Biologikatherapie bei erzielter CRSwNP-Kontrolle sind unabdingbar.

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“…Therefore, initial gradual reduction of ICS to the lowest possible ICS dose before discontinuation of LABA is recommended[ 175 ] If the patient is on a combination of ICS and LABA, LTRA, or other controllers; start by tapering ICS to the lowest possible dose (Evidence B). [ 176 177 ] If control is achieved, LTRA may be discontinued first (Evidence D)[ 176 ] For significant oral side effects occur, consider a change in therapy, reduction in the dose or frequency of ICS (if possible), advise vigorous mouth washing after inhalation, use of spacer (concomitant with MDI devices), and/or use of appropriate local antifungal therapy for severe oral thrush[ 178 ] For patients with well-controlled eosinophilic asthma treated with mepolizumab for at least 18 months, extending the dosage intervals gradually between the injections up to 6–8 weeks bears the potential to save costs for the health care system without compromising asthma control[ 179 ] For patients with well-controlled asthma treated with omalizumab for at least 18 months, extending the dosage intervals gradually between the injections up to 3–4 weeks bears the potential to save costs for the health care system without compromising asthma control[ 180 ] Patients should be informed that asthma control may deteriorate if treatment is completely discontinued. [ 174 ] …”

Section: Section 6: Pharmacological Management In Adults and Adolescentsmentioning

confidence: 99%

“…For patients with well-controlled eosinophilic asthma treated with mepolizumab for at least 18 months, extending the dosage intervals gradually between the injections up to 6–8 weeks bears the potential to save costs for the health care system without compromising asthma control[ 179 ]…”

Section: Section 6: Pharmacological Management In Adults and Adolescentsmentioning

confidence: 99%

The Saudi initiative for asthma – 2024 update: Guidelines for the diagnosis and management of asthma in adults and children

Al-Moamary,

Alhaider,

Allehebi

et al. 2023

Annals of Thoracic Medicine

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The Saudi Initiative for Asthma 2024 (SINA-2024) is the sixth version of asthma guidelines for the diagnosis and management of asthma for adults and children that was developed by the SINA group, a subsidiary of the Saudi Thoracic Society. The main objective of the SINA is to have guidelines that are up-to-date, simple to understand, and easy to use by healthcare workers dealing with asthma patients. To facilitate achieving the goals of asthma management, the SINA Panel approach is mainly based on the assessment of symptom control and risk for both adults and children. The approach to asthma management is aligned for age groups: adults, adolescents, children aged 5–12 years, and children aged <5 years. SINA guidelines have focused more on personalized approaches reflecting a better understanding of disease heterogeneity with the integration of recommendations related to biologic agents, evidence-based updates on treatment, and the role of immunotherapy in management. The medication appendix has also been updated with the addition of recent evidence, new indications for existing medication, and new medications. The guidelines are constructed based on the available evidence, local literature, and the current situation at national and regional levels. There is also an emphasis on patient–doctor partnership in the management that also includes a self-management plan.

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Extension of mepolizumab injection intervals as potential of saving costs in well controlled patients with severe eosinophilic asthma

Cited by 6 publications

References 20 publications

Clinical Remission Criteria and Serum Levels of Type 2 Inflammation Mediators during 24 Weeks of Treatment with the Anti-IL-5 Drug Mepolizumab in Patients with T2-High Severe Asthma

Clinical Remission Criteria and Serum Levels of Type 2 Inflammation Mediators during 24 Weeks of Treatment with the Anti-IL-5 Drug Mepolizumab in Patients with T2-High Severe Asthma

Chronische Rhinosinusitis mit nasalen Polypen – Verlängerung der Dupilumab-Therapieintervalle

The Saudi initiative for asthma – 2024 update: Guidelines for the diagnosis and management of asthma in adults and children

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