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OverviewMechanism of ActionUsesBenfitsIndicationsWarnings and Precautions for usingAdverse ReactionsSide EffectsClinical Pharmacology Clinical StudiesAuthored by Reviewed by References
Quilizumab

Quilizumab

Indications, Uses, Dosage, Drugs Interactions, Side effects
Quilizumab
Medicine Type :
Allopathy
Prescription Type:
Prescription Required
Approval :
Investigational Drug

Quilizumab belongs to the Anti IgG1 Monoclonal Antibodies Pharmacological class.

Quilizumab is investigated for the treatment of severe asthma.

Quilizumab is a humanized IgG1 monoclonal antibody that targets the M1-prime segment of membrane-expressed IgE. This in turn leads to depletion of IgE-switched and memory B cells. In patients suffering from mild asthma, quilizumab reduced serum IgE and attenuated the early and late asthmatic reaction which was followed by the whole lung allergen challenge.

Quilizumab, hence leads to relief from mild to severe asthmatic conditions.

Quilizumab can be used in the treatment of:

• Mild to severe asthma

Quilizumab can help to relieve symptoms of Asthma.

Quilizumab is investigated for use in the following clinical indications:

• Mild to severe Asthma

Food Warning

No sufficient scientific evidence traceable regarding the use and safety of Quilizumab in concurrent use with any particular food.

Some tumor malignancy has been reported in the clinical studies.

• Pharyngitis

• Mid itching or burn at the site of injection

• Headache.

• Type I Hypersensitivity

Pharmacodynamics

Qualizumab reduces the mean serum total and allergen specific concentrations IgE levels, reaching a 30-40% in 36 weeks of 3 cohort studies. The intense decrease in the allergens levels was achieved in the 42nd week in the 300mg M treatment cohort study

No significant improvement was observed in the asthma patients at 36 weeks and no specific improvement in the lung problems was observed at weeks 12 and 36 weeks in Patients treated with Qualizumabs.

Pharmacokinetics

Quilizumab showed linear pharmacokinetics with a dose-proportional increase in exposure as it is proved by the increase in Cmax values between the 150 and 450 mg Quilizumab doses at Weeks 5 and 25. At treatment of Weeks 4, 12, and 24, the mean trough serum concentrations of Quilizumab of 150 mg dose was found to be 5.7 ± 2.3 μg/mL, 2.6 ± 2.0 μg/mL, and 1.3 ± 4.6 μg/mL, respectively; at doses of 450 mg mean trough serum concentrations was found t be 17.1 ± 7.0 μg/mL, 7.2 ± 3.8 μg/mL, and 2.3 ± 2.2 μg/mL, respectively. For the 150 mg , 450 mg and 300 mg M doses, the mean Cmax,observed values were found to be 18 ± 7.8 μg/mL, 51.6 ± 19.5 μg/mL, and 34 ± 12.6 μg/mL, which occurred at Tmax,observed values were found to be 36.4 ± 4.3 days, 36.2 ± 3.0 days, and 36.2 ± 3.5 days, respectively, which is approximately 7 days following the second doses. Based on non-compartmental analysis, the mean t1/2 values of quilizumab across the dose groups ranged between 16.4 to 18.7 days. This suggests that steady-state was attained by the time the final doses were administered for both monthly and quarterly regimens.

1) Wenzel SE. Asthma phenotypes: the evolution from clinical to molecular approaches. Nat Med. 2012;18:716–25.

2) Lötvall J, et al. Asthma endotypes: a new approach to classification of disease entities within the asthma syndrome. J Allergy Clin Immunol. 2011;127:355–60.

3) Agache I, et.al. Untangling asthma phenotypes and endotypes. Allergy. 2012;67:835–46.

4) Hekking PP, Bel EH. Developing and emerging clinical asthma phenotypes. J Allergy Clin Immunol Pract. 2014;2:671–80.

5) Agache I, et.al. The complex type 2 endotype in allergy and asthma: from laboratory to bedside. Curr Allergy Asthma Rep. 2015;15:29.

6) Woodruff PG, et al. T-helper type 2-driven inflammation defines major subphenotypes of asthma. Am J Respir Crit Care Med. 2009;180:388–95.

7) Gauthier M, Ray A, Wenzel SE. Evolving concepts of asthma. Am J Respir Crit Care Med. 2015;192:660–8.

8) Hanania NA, et al. Lebrikizumab in moderate-to-severe asthma: pooled data from two randomised placebo-controlled studies. Thorax. 2015;70(8):748–56.

9) Hanania NA, et al. Exploring the effects of omalizumab in allergic asthma: an analysis of biomarkers in the EXTRA study. Am J Respir Crit Care Med. 2013;187:804–11.

10) Brightbill HD, et al. Quilizumab is an afucosylated humanized anti-M1 prime therapeutic antibody. Clin Anti-Inflamm & Anti-Allergy Drugs. 2014;1:24–31.

11) Peng C, et.al. A new isoform of human membrane-bound IgE. J Immunol. 1992;148:129–36.

1.https://pubchem.ncbi.nlm.nih.gov/substance/310264776#section=Information-Sources

2.https://www.researchgate.net/publication/292373031_Efficacy_and_Safety_of_Quilizumab_in_Adults_with_Allergic_Asthma_Inadequately_Controlled_on_Inhaled_Corticosteroids_and_a_Second_Controller_COSTA_Study

3. https://respiratory-research.biomedcentral.com/articles/10.1186/s12931-016-0347-2

4. https://clinmedjournals.org/articles/jor/journal-of-otolaryngology-and-rhinology-jor-4-042.php?jid=jor

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Sonali R Muralidhar
I am Sonali R Muralidhar currently residing at Madurai.I have completed my Master’s in Pharmacy with my core subject as Pharmaceutics. I am interested in Pharmaceutical research , medical content writing, Biopharmaceutics , regulatory affairs , novel drug delivery, targeted drug delivery.
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Dr JUHI SINGLA
Dr JUHI SINGLA has completed her MBBS from Era’s Lucknow Medical college and done MD pharmacology from SGT UNIVERSITY Gurgaon. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751
Published on: 4 Oct 2022 8:54 AM GMT
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