Table A1.
Summary of the Studies Including Patients Treated with Omalizumab.
| Study | Type of Study | Number of Patients | Dose Used | Previous Treatments | Results Obtained | Side Effects | Observations | Level of Evidence |
|---|---|---|---|---|---|---|---|---|
| “Cao P et al. (2022)” [23] | Systematic review 75 studies included | 211 patients with BP, 53 treated with omalizumab, 122 with RTX and 36 with dupilumab | NE, average treatment duration 6.6 months | CTC, MTX, MMF, AZA, CLP, CFF | Complete BP remission in 67.9% of patients (36/56) and partial remission in20.8% (11/53) | Recurrence 5.7% (3/53) Death due to thrombocytopenia(1.9%, 1/53) |
The rest of the patients included in the study (122) were treated with RTX, giving a higher number of recurrences, AEs and mortality | 2a |
| “Oren-Shabtai M et al. (2023)” [22] | Presentation of 9 cases | 9, 3 of them treated with omalizumab, 7 with RTX and 1 with dupilumab, average age 60.4 years | 300 mg every 4 weeks | CTC, BIO, RTX | 78% clinical improvement, 55% complete remission at 3 months | None | omalizumab achieves greater IgE reduction. Multiple comorbidities: Parkinson’s, dementia, DM, HF, hypothyroidism, IR | 4 |
| “D’Aguanno K et al. (2022)” [24] | Systematic review of 22 articles | 56 | 300 mg every 4 weeks. One patient received a single dose of 450 mg | CTC | 87.5% respond to treatment at 13 weeks (55.4% complete remission, 32.1% partial) | None | NP | 2a |
| “Seyed J et al. (2020)” [25] | Presentation of 1 case | 1, M 70 years | 300 mg every 4 weeks | CTC, DAP, MTX, MMF | Decrease in BP-100, EVA scale went from 9/10 to 2/10 after 2 months. Complete remission after 3 months | Persistent pruritus that was resolved by adding 600 mg dupilumab + 300 mg dupilumab | Complete remission with omalizumab + dupilumab after trying various treatments. Pcte with metabolic ds | 4 |
| “Vassallo C et al. (2022)” [26] | Retrospective study of 222 patients | 222, 5 BP-dependent CTC patients with IC were selected for other treatments. Average age: 77.4 years. 3M, 2F | 300 mg every 4 weeks, treatment duration: average 9.2 months | CTC, IS, AH | Resolution of skin lesions in all patients and reduction of pruritus. Reduction of IgE and anti-BP180, BP230 and eosinophils | NE | Patients with several comorbidities: DM2, hepatitis, hip replacement, vitiligo, osteoporosis | 4 |
| “Kremer N et al. (2019)” [11] | Systematic review of 35 publications | 84 PCs (62 receive RTX and 22 omalizumab) | NE | CTC | Complete remission 85% with RTX and 84% with omalizumab | 24% in treatment with RTX and 20% with omalizumab | Fewer recurrences with RTX than with omalizumab | 2a |
| “Velin M et al. (2022)” [27] | Retrospective study | 112 (19 met inclusion criteria), mean age 76 years | 300 mg every 4 weeks SB, average of 9 months of treatment | CTC, MTX | 60% complete remission, 20% partial remission | One case with poor skin tolerance (burning sensation) for treatment with dupilumab (lasted 1 month with treatment) | Of the 19 patients, 12 received MTX, 7 omalizumab and 8 dupilumab | 4 |
| “Kwon IJ et al. (2023)” [17] | Retrospective study | 49 (25 RTX only, 17 RTX + omalizumab) | 13 patients: 300 mg omalizumab twice (every 4 weeks) and 4 patients 300 mg omalizumab once | CTC, RTX | RTX + omalizumab improvement in 15 days vs. 67.5 days if only RTX. Control only RTX 92% vs. RTX + omalizumab 100% | None | 0% mortality RTX + omalizumab, 16% if RTX monotherapy | 4 |
| “Yu KK et al. (2022)” [28] | Open, uncontrolled study | 6, F, average age 72.8 years | 300 mg every 2–4 weeks (6 cycles) | CTC, AZA, MC | Benefit in 5/6 patients with reduction in pruritus, eosinophils, blisters at 2 weeks | None | All failed previous treatment with CTC | 4 |
| “Seyed J et al. (2019)” [29] | Presentation of 2 cases | 2, between 60–65 years | 300 mg every 2 weeks for 1 month | CTC, AZA, TC | After 1 month of treatment with AOM, blisters and itching disappear | None | NP | 4 |
| “Alexandre M et al. (2022)” [30] | Retrospective study | 13, 5M, 8F, average age 66 years | 300 mg/450 mg/600 mg | CTC, MMF, DOX, MTX | Improvement in pruritus, hives, blisters, complete remission 85% at 3 months | 2 pneumonias, 1 kidney failure in very frail elderly patients (no clear correlation with omalizumab use) | 7/13 had mucosal involvement | 4 |
| “James T et al. (2019)” [31] | Presentation of 1 case | 1, M 72 years | NE | CTC, IS, IVIg, RTX | Resolution of blisters, IgG decrease | NE | Multiple comorbidities: DM2, CKD grade IV | 4 |
| “Ewy S et al. (2019)” [32] | Presentation of 1 case | 1, F 74 years | 300 mg every 4 weeks | NE | Reduction of pain and skin lesions | Injection site dermatitis that resolved spontaneously within 2 days | NP | 4 |
| “Navarro-Triviño FJ et al. (2021)” [33] | Presentation of 1 case | 1M, 70 years | 300 mg subcutaneously every 3 weeks | CTC, AZA | Blisters disappear after 3 months | None | Analytical findings and refusal of patient to be treated with RTX due to PML risk | 4 |
| “Balakirski G et al. (2016)” [34] | Presentation of 2 cases | 2, F 40 years old, M 63 years old | 1. 300 mg every 3 weeks 2. 300 mg every 3 weeks |
1. CTC, AZA 2. CTC |
1 and 2: Pruritus improvement after 5 days of treatment with omalizumab | None | 1. omalizumab was started at 300 mg every 4 weeks, but due to increased blisters, 300 mg was started every 3 weeks. 2. omalizumab was discontinued due to other health problems, reappearance of blisters, continued CTC |
4 |
| “Garrido PM et al. (2020)” [13] | Presentation of 1 case | 1, F 76 years | 300 mg every 4 weeks | CTC, DOX, AZA, IVIg | Pruritus disappears after 3 days, complete resolution of skin lesions after 2 months | None | BP triggered by treatment with DDP-4 (vildagliptin) for DM treatment | 4 |
| “From D et al. (2021)” [35] | Presentation of 6 cases | 6 (4F, 2M), average age 64.5 years | 300 mg every 4 weeks | NE, but CTC contraindicated due to comorbidities | NE | NE | Patients treated with AOM since due to their comorbidities they are IC other treatments | 4 |
| “Gönül MZ et al. (2016)” [36] | Presentation of 1 case | 1, M 70 years | 300 mg every 4 weeks, total of 11 doses | CTC, TC, DAP | Disappearance of blisters, IgE decrease a week after treatment | Thrombocytopenia that did not require discontinuation of omalizumab | NP | 4 |
| “Lonowski S et al. (2020)” [37] | Retrospective study | 11, average age 78 years | 10 treatments with 300 mg omalizumab every 4 weeks. One treatment with 375 mg every 2 weeks | CTC, RTX, AZA | 6/11 complete answer 3/11 partial answer 2/11 no response |
1 of them exacerbation of skin lesions that required discontinuation of omalizumab 1 of them had infection, died and had treatment with CTC 9/11 no adverse effects |
The exacerbation of lesions with AOM was an AE that had not previously appeared and is the result of future research. | 4 |
| “Menzinger S et al. (2018)” [38] | Presentation of a case | 1, F 76 years | 300 mg every 4 weeks | CTC | Disappearance of the disease after 8 weeks of treatment, itching improves after 2 days | None | Multiple comorbidities (CKD dementia, ischemic heart disease…) | 4 |
| “Liu J et al. (2022)” [39] | Presentation of a case | 1, M 76 years | 300 mg every 4 weeks | AH, CTC | After 3 days itching improved, no new blisters appeared | NE | Multiple comorbidities that CI tto IS | 4 |
| “Yalcin AD et al. (2014)” [40] | Presentation of a case | 1, M 28 years | 300 mg, 13 doses in total | CTC, CFF | Complete remission | NE | Young person (28 years old) | 4 |
| “London VA et al. (2012)” [41] | Presentation of 1 case | 1, F 70 years | 300 mg every 4 weeks | CTC, AZA, MMF, CFF | Disappearance of blisters, decrease in anti BP180, disappearance of findings in IF | None | NP | 4 |
| “Barrios DM et al. (2021)” [14] | Retrospective study | 34, 50% F mean age 67.5 a (9 of them due to BP) due to QT drug effects | NE | Combination with ipilimumab, atezolizumab, durvalumab | omalizumab improves pruritus and BP | 2/9 did not respond to omalizumab) | Treatment with AOM for complications QT treatment in solid tumors | 4 |
| “Sinha S et al. (2020)” [42] | Presentation of a case | 1, F 44 years | 450 mg | CTC, RTX, AZA | Disappearance of blisters | NE | Obesity | 4 |
| “Dufour C et al. (2012)” [43] | Presentation of 1 case | 1M 5 months | 100 mg, every 2 weeks for 3 months | CTC, AZA | Reduction of urticarial lesions and blisters. Complete resolution after 10 months of treatment | NE | BP in a 5-month-old baby | 4 |
| “Fairley JA et al. (2009)” [44] | Presentation of a case | 1, F 70 years | 300 mg every 2 weeks | CTC, AZA, MC | Partial remission, decrease in eosinophils and anti BP180 | NE | NP | 4 |
| “From A et al. (2021)” [45] | Presentation of 3 cases | 1 of them with BP, M 65 years old | 300 mg every 4 weeks | CTC, MMF | Complete remission after 3 months of treatment | NE | NP | 4 |
| “Chebani R et al. (2024)” [46] | Retrospective study | 100, average age 77 years | 300 mg | NE | Complete remission 77% at 3 months | NE | More significant improvement if high levels of anti BP180 | 4 |
AF: family history, HBsAg: hepatitis B surface antigen, AH: antihistamines, ATB: antibiotic, AZA: azathioprine, BIO: biological, BPDAI: bullous pemphigoid disease area index, CFF: cyclophosphamide, CH: colchicine, IC: contraindication, CLP: cyclosporine, CMV: cytomegalovirus, CTC: corticosteroids, DAP: dapsone, DM: diabetes mellitus, DOX: doxycycline, dupilumab dupilumab, CKD: chronic kidney disease, VAS: visual analog pain scale, F: woman, AF: atrial fibrillation, HTN: arterial hypertension, IC: heart failure, IDPP4: dipeptidyl peptidase 4 inhibitors, IF: immunofluorescence, Ig: immunoglobulins, IVIg: intravenous Ig, IM: immunomodulators, IR: renal failure, IS: immunosuppressants, PML: progressive multifocal leukoencephalopathy, M: male, MC: minocycline, MG: milligrams, MMF: mycophenolate mofetil, MTP: methylprednisolone, MTX: methotrexate, No.: number, NE: not specified, NP: not applicable, NT: nicotinamide, AOM: omalizumab, PA: bullous pemphigoid, PCTE: patient, QT: chemotherapy, PROM: premature rupture of membranes, RTX: rituximab, SB: subcutaneous, SD: syndrome, SEM: week, OS: week of gestation, TBC: tuberculosis, TC: tetracyclines, PET: pulmonary thromboembolism, TTO: treatment, HIV: human immunodeficiency virus.