Off-Label Benralizumab in Severe Non-Necrotizing Eosinophilic Vasculitis following Critical COVID-19 Disease and in DRESS
Abstract
:1. Introduction
2. Compassionate Use of a Single Dose of Off-Label Benralizumab in Severe Non-Necrotizing Vasculitis following Critical COVID-19 Disease
3. Off-Label Benralizumab in DRESS to Allopurinol
4. Discussions
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
- Laviolette, M.; Gossage, D.L.; Gauvreau, G.; Leigh, R.; Olivenstein, R.; Katial, R.; Busse, W.W.; Wenzel, S.; Wu, Y.; Datta, V.; et al. Effects of benralizumab on airway eosinophils in asthmatic patients with sputum eosinophilia. J. Allergy Clin. Immunol. 2013, 132, 1086–1096.e5. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Ghazi, A.; Trikha, A.; Calhoun, W.J. Benralizumab—A humanized mAb to IL-5Ralpha with enhanced antibody-dependent cell-mediated cytotoxicity--a novel approach for the treatment of asthma. Expert Opin. Biol. Ther. 2012, 12, 113–118. [Google Scholar] [CrossRef] [PubMed]
- Dávila González, I.; Moreno Benítez, F.; Quirce, S. Benralizumab: A New Approach for the Treatment of Severe Eosinophilic Asthma. J. Investig. Allergol. Clin. Immunol. 2019, 29, 84–93. [Google Scholar] [CrossRef] [PubMed]
- Bagnasco, D.; Ferrando, M.; Varricchi, G.; Puggioni, F.; Passalacqua, G.; Canonica, G.W. Anti-Interleukin 5 (IL-5) and IL-5Ra Biological Drugs: Efficacy, Safety, and Future Perspectives in Severe Eosinophilic Asthma. Front. Med. 2017, 4, 135. [Google Scholar] [CrossRef] [PubMed]
- Bleecker, E.R.; FitzGerald, J.M.; Chanez, P.; Papi, A.; Weinstein, S.F.; Barker, P.; SIROCCO Study Investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): A randomised, multicentre, placebo-controlled phase 3 trial. Lancet 2016, 388, 2115–2127. [Google Scholar] [CrossRef]
- FitzGerald, J.M.; Bleecker, E.R.; Nair, P.; Korn, S.; Ohta, K.; Lommatzsch, M.; CALIMA Study Investigators. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): A randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2016, 388, 2128–2141. [Google Scholar] [CrossRef]
- Kuang, F.L.; Legrand, F.; Makiya, M.; Ware, J.; Wetzler, L.; Brown, T.; Magee, T.; Piligian, B.; Yoon, P.; Ellis, J.H.; et al. Benralizumab for PDGFRA-Negative Hypereosinophilic Syndrome. N. Engl. J. Med. 2019, 380, 1336–1346. [Google Scholar] [CrossRef]
- Criner, G.J.; Celli, B.R.; Brightling, C.E.; Agusti, A.; Papi, A.; Singh, D.; Sin, D.D.; Vogelmeier, C.F.; Sciurba, F.C.; Bafadhel, M.; et al. Benralizumab for the Prevention of COPD Exacerbations. N. Engl. J. Med. 2019, 381, 1023–1034. [Google Scholar] [CrossRef] [Green Version]
- Tversky, J.; Lane, A.P.; Azar, A. Benralizumab effect on severe chronic rhinosinusitis with nasal polyps (CRSwNP): A randomized double-blind placebo-controlled trial. Clin. Exp. Allergy 2021, 51, 836–844. [Google Scholar] [CrossRef]
- Maurer, M.; Khan, D.A.; Elieh Ali Komi, D.; Kaplan, A.P. Biologics for the Use in Chronic Spontaneous Urticaria: When and Which. J. Allergy Clin. Immunol. Pract. 2021, 9, 1067–1078. [Google Scholar] [CrossRef] [PubMed]
- Kolkhir, P.; Altrichter, S.; Munoz, M.; Hawro, T.; Maurer, M. New treatments for chronic urticaria. Ann. Allergy Asthma Immunol. 2020, 124, 2–12. [Google Scholar] [CrossRef]
- Guntur, V.P.; Manka, L.A.; Denson, J.L.; Dunn, R.M.; Dollin, Y.T.; Gill, M.; Kolakowski, C.; Strand, M.J.; Wechsler, M.E. Benralizumab as a Steroid-Sparing Treatment Option in Eosinophilic Granulomatosis with Polyangiitis. J. Allergy Clin. Immunol. Pract. 2021, 9, 1186–1193.e1. [Google Scholar] [CrossRef]
- Miyata, Y.; Inoue, H.; Homma, T.; Tanaka, A.; Sagara, H. Efficacy of Benralizumab and Clinical Course of IgG4 in Eosinophilic Granulomatosis With Polyangiitis. J. Investig. Allergol. Clin. Immunol. 2021, 31, 346–348. [Google Scholar] [CrossRef]
- Shamriz, O.; Hershko, A.Y.; Talmon, A.; Ribak, Y.; Elazary, A.S.; Horev, L.; NaserEddin, A.; Neuman, T.; Shabat, S.; Zlotogorski, A.; et al. The efficacy of off-label IL-5-modulating treatment in rare eosinophil-mediated diseases. Allergol. Int. 2021, 70, 266–268. [Google Scholar] [CrossRef]
- Menzella, F.; Galeone, C.; Ghidoni, G.; Ruggiero, P.; Capobelli, S.; Simonazzi, A.; Catellani, C.; Scelfo, C.; Livrieri, F.; Facciolongo, N. Successful treatment with benralizumab in a patient with eosinophilic granulomatosis with polyangiitis refractory to mepolizumab. Multidiscip. Respir. Med. 2021, 16, 779. [Google Scholar] [CrossRef]
- Kardaun, S.H.; Sekula, P.; Valeyrie-Allanore, L.; Liss, Y.; Chu, C.Y.; Creamer, D.; RegiSCAR Study Group. Drug reaction with eosinophilia and systemic symptoms (DRESS): An original multisystem adverse drug reaction. Results from the prospective RegiSCAR study. Br. J. Dermatol. 2013, 169, 1071. [Google Scholar] [CrossRef]
- Ramirez, G.A.; Yacoub, M.R.; Ripa, M.; Mannina, D.; Cariddi, A.; Saporiti, N.; Ciceri, F.; Castagna, A.; Colombo, G.; Dagna, L. Eosinophils from Physiology to Disease: A Comprehensive Review. BioMed Res. Int. 2018, 2018, 9095275. [Google Scholar] [CrossRef] [Green Version]
- Pala, D.; Pistis, M. Anti-IL5 Drugs in COVID-19 Patients: Role of Eosinophils in SARS-CoV-2-Induced Immunopathology. Front. Pharmacol. 2021, 12, 622554. [Google Scholar] [CrossRef]
- Cortés-Vieyra, R.; Gutiérrez-Castellanos, S.; Álvarez-Aguilar, C.; Baizabal-Aguirre, V.M.; Nuñez-Anita, R.E.; Rocha-López, A.G.; Gómez-García, A. Behavior of Eosinophil Counts in Recovered and Deceased COVID-19 Patients over the Course of the Disease. Viruses 2021, 13, 1675. [Google Scholar] [CrossRef]
- Sun, S.; Cai, X.; Wang, H.; He, G.; Lin, Y.; Lu, B.; Chen, C.; Pan, Y.; Hu, X. Abnormalities of peripheral blood system in patients with COVID-19 in Wenzhou, China. Clin. Chim. Acta. 2020, 507, 174–180. [Google Scholar] [CrossRef]
- Davido, B.; Partouche, B.; de Truchis, P.K.; Herr, M.; Pepin, M. Eosinopenia in COVID-19: What we missed so far? J. Microbiol. Immunol. Infect. 2021, 54, 1006. [Google Scholar] [CrossRef] [PubMed]
- Lippi, G.; Henry, B.M. Eosinophil count in severe coronavirus disease 2019. QJM 2020, 113, 511–512. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Lindsley, A.W.; Schwartz, J.T.; Rothenberg, M.E. Eosinophil responses during COVID-19 infections and coronavirus vaccination. J. Allergy Clin. Immunol. 2020, 146, 1–7. [Google Scholar] [CrossRef] [PubMed]
- Gauvreau, G.M.; Pageau, R.; Séguin, R.; Carballo, D.; Gauthier, J.; D’anjou, H.; Renzi, P.M. Dose-response effects of TPI ASM8 in asthmatics after allergen. Allergy Eur. J. Allergy Clin. Immunol. 2011, 66, 1242–1248. [Google Scholar] [CrossRef]
- Muntean, I.A.; Pintea, I.; Bocsan, I.C.; Dobrican, C.T.; Deleanu, D. COVID-19 Disease Leading to Chronic Spontaneous Urticaria Exacerbation: A Romanian Retrospective Study. Healthcare 2021, 9, 1144. [Google Scholar] [CrossRef]
- Bossuyt, X.; Cohen Tervaert, J.W.; Arimura, Y.; Blockmans, D.; Flores-Suárez, L.F.; Guillevin, L.; Csernok, E. Revised 2017 international consensus on testing of ANCAs in granulomatosis with polyangiitis and microscopic polyangiitis. Nat. Rev. Rheumatol. 2017, 13, 683–692. [Google Scholar] [CrossRef]
- Jarczak, D.; Kluge, S.; Nierhaus, A. Use of Intravenous Immunoglobulins in Sepsis Therapy-A Clinical View. Int. J. Mol. Sci. 2020, 21, 5543. [Google Scholar] [CrossRef]
- Shoenfeld, Y.; Katz, U. IVIg therapy in autoimmunity and related disorders: Our experience with a large cohort of patients. Autoimmunity 2005, 38, 123–137. [Google Scholar] [CrossRef]
Variables (n.r.) (Unit of Measurement) | Days before and after the Administration | ||||||
---|---|---|---|---|---|---|---|
−3 | −2 | −1 | 0 | 1 | 2 | 3 | |
Leukocytes (4–10) (103/μL) | 12.32 | 11.93 | 13.71 | 9.46 | 8.60 | 9.40 | 9.40 |
Neutrophils (30–75) (%) | 68.9 | 68.8 | 70 | 80.6 | 66.9 | 56.1 | 58.1 |
Neutrophils (2–7.5) (103/μL) | 8.49 | 8.21 | 9.61 | 7.62 | 5.76 | 5.27 | 7.47 |
Eosinophils (1–4) (%) | 3.9 | 3.9 | 4.7 | 1.9 | 0.0 | 0.00 | 0.00 |
Eosinophils (0.05–0.4) (103/μL) | 0.48 | 0.46 | 0.64 | 0.18 | 0.00 | 0.00 | 0.00 |
Lymphocytes (20–40) (%) | 18.2 | 19.1 | 18.5 | 14.9 | 27.8 | 36.7 | 32.9 |
Lymphocytes (1.5–4) (103/μL) | 2.24 | 2.28 | 2.53 | 1.41 | 2.39 | 3.45 | 4.23 |
PLT (140–440) (103/μL) | 437 | 459 | 198 | 543 | 618 | 614 | 588 |
CRP (0–1) (mg/dL) | 9.7 | 9.37 | 12.37 | 10.44 | 6.22 | 3.28 | 2.05 |
D-dimers (<0.5) (ng/mL) | 6.24 | 6.24 | 6.73 | 7.76 | 6.22 | 5.19 | 3.1 |
Parameter | Score | Comments | ||
---|---|---|---|---|
−1 | 0 | 1 | ||
Fever ≥ 38.5 °C | No/unknown | Yes | ||
Lymphadenopathy | No/Unknown | Yes | >1 cm, at least two sites | |
Eosinophilia ≥ 0.7 × 109 or ≥10% if leucopenia | No/Unknown | Yes | Score 2 points of ≥1.5 × 109 | |
Atypical lymphocytes | No/Unknown | Yes | ||
Skin rash | Suggestive features: ≥2 facial edemas, purpura, infiltration, and desquamation | |||
Rash suggestive of DRESS | No | Unknown | Yes | |
Extent ≥ 50% of BSA | No/Unknown | Yes | ||
Skin biopsy suggestive of DRESS | No | Yes/Unknown | ||
Organ involvement | No | Yes | 1 point for each organ involvement, maximum score: 2 | |
Disease duration ≥ 15 days | No/unknown | Yes | ||
Exclusion of other causes | No/Unknown | Yes | 1 point if three of the following tests are performed and are negative: HAV, HBV, HCV, mycoplasma, chlamydia, ANA, and blood culture |
Variables (n.r.) (Unit of Measurement) | Days before and after the Administration | ||||
---|---|---|---|---|---|
−1 | 0 | 1 | 2 | 3 | |
Leukocytes (4–10) (103/μL) | 12.4 | 12.5 | 9.99 | 9.42 | 9.5 |
Neutrophils (30–75) (%) | 54 | 55.1 | 87.1 | 87.6 | 87.3 |
Neutrophils (2–7.5) (103/μL) | 6.70 | 6.71 | 8.70 | 8.25 | 8.6 |
Eosinophils (1–4) (%) | 25 | 21.6 | 0.1 | 0.9 | 0.00 |
Eosinophils (0.05–0.4) (103/μL) | 2.59 | 2.62 | 0.01 | 0.09 | 0.00 |
Lymphocytes (20–40) (%) | 12.5 | 12 | 9.0 | 7.2 | 7.12 |
Lymphocytes (1.5–4) (103/μL) | 1.45 | 1.45 | 0.90 | 0.68 | 0.69 |
PLT (140–440) (103/μL) | 532 | 532 | 533 | 484 | 440 |
CRP (0–1) (mg/dL) | 1.59 | 1.59 | 1.6 | 1.58 | 1.29 |
Urea nitrogen (18–48) (mg/dL) | 180 | 183 | 166 | 157 | 155 |
Creatinine (0–1.10) (mg/dL) | 1.67 | 1.66 | 1.58 | 1.53 | 1.54 |
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Pintea, I.; Muntean, I.A.; Dobrican, C.T.; Miron, N.; Deleanu, D. Off-Label Benralizumab in Severe Non-Necrotizing Eosinophilic Vasculitis following Critical COVID-19 Disease and in DRESS. J. Clin. Med. 2022, 11, 6642. https://doi.org/10.3390/jcm11226642
Pintea I, Muntean IA, Dobrican CT, Miron N, Deleanu D. Off-Label Benralizumab in Severe Non-Necrotizing Eosinophilic Vasculitis following Critical COVID-19 Disease and in DRESS. Journal of Clinical Medicine. 2022; 11(22):6642. https://doi.org/10.3390/jcm11226642
Chicago/Turabian StylePintea, Irena, Ioana Adriana Muntean, Carmen Teodora Dobrican, Nicolae Miron, and Diana Deleanu. 2022. "Off-Label Benralizumab in Severe Non-Necrotizing Eosinophilic Vasculitis following Critical COVID-19 Disease and in DRESS" Journal of Clinical Medicine 11, no. 22: 6642. https://doi.org/10.3390/jcm11226642