Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)
Study Details
Study Description
Brief Summary
This study was a retrospective cohort study of patients to assess the early insights into real-world safety among wet AMD patients initiating brolucizumab. Evidence was generated to describe their patient characteristics and clinical outcomes. The study was conducted using the Komodo Healthcare Map.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
Komodo Healthcare Map claims data from 08-Oct-2016 to the date of most recent data from patients with wet AMD who initiated brolucizumab were analyzed in this study.
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Identification period of the index date (index period): The patients fulfilling the selection criteria were identified during the period from 08-Oct-2019 to 30-Apr-2020.
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Index date: Defined as the date of the earliest brolucizumab injection during the index period.
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Study Period: The period from 08-Oct-2016 to the most recent data extraction date (05-Jun-2020).
o Note since 05-Jun-2020 was the date data was pulled, claims data from recent months (e.g. May) may be incomplete (relative to the final DB state) as well.
- Pre-index period: The period 36 months prior to the index date
o Note: Data within 36 months prior to the index date will be used to assess baseline characteristics.
- Post-index period: The period of 180 days after the index date
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Brolucizumab Participants received brolucizumab injection during the index period |
Drug: Brolucizumab
Participants received brolucizumab injection during the index period
Other Names:
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Outcome Measures
Primary Outcome Measures
- Number of patient eyes with an Intraocular Inflammation (IOI) event during the first 6 months [Up to 6 months post brolucizumab injection]
To assess IOI events observed after starting treatment with brolucizumab
Secondary Outcome Measures
- Age [Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)]
Age information was reported
- Gender information [Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)]
Gender information was reported
- Number of patients at various Patient Region [Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)]
Patient regions: Northeast, Midwest, South, West, Unknown
- Number of patients with Insurance type [Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)]
Insurance type: Private, Medicare, Medicare Advantage, Medicaid, Other
- Number of patients with Laterality of wet Age-related macular degeneration (AMD) [Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)]
Laterality of wet AMD: Unilateral, Bilateral
- Number of patients with Laterality of any Age-related macular degeneration (AMD) [Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)]
Laterality of wet AMD: Unilateral, Bilateral
- Number of eyes with the concurrent eye disease [Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)]
Types of concurrent eye diseases: Cataracts Posterior vitreous detachment Puckering of macula Macular hole Vitreomacular traction Glaucoma Amblyopia Papillitis Ischemic optic atrophy Diabetic retinopathy Diabetic macular edema Hypertensive retinopathy Pathologic myopia RAO RO RV Vitritis Endophthalmitis Uveitis Choroidal neovascularization (due to causes other than AMD, if possible, to determine) IOI
- Number of patient eyes with previous ocular surgeries or procedures [Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)]
Types: Laser photocoagulation (or laser therapy) Photodynamic therapy (PDT) Glaucoma surgery (trabeculectomy, MIGS) Cataract surgery Iridotomy Ocular radiation Panretinal photocoagulation Submacular surgery, other surgical intervention or laser treatment for AMD Vitrectomy Scleral buckle Pneumatic retinopexy Cryopexy
- Number of patient eyes with systemic comorbidities [36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)]
Types: Obesity Cerebrovascular disease Peripheral vascular disease Diabetes Renal disease Chronic pulmonary disease Congestive heart failure Any malignancy, including lymphoma and leukemia Myocardial infarction Dementia Arteriothrombotic event Thromboembolytic event Atherosclerosis Arterial hypertension Ischemic heart disease Atrial fibrillation Lipid disorders Cardiac septal defect Valvular cardiac defect Hyperlipidemia Hypercholesterolemia Atherosclerotic disease Thrombosis Carotid artery disease
- Number of Concomitant systemic medications (chronic use) [36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)]
Types: Corticosteroids Systemic anti-VEGFs Lipid lowering agents Antihypertensives Biologics Antimetabolites/cancer therapy Anticoagulants
- Number of patient eyes with the Cataract status [36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)]
Types: phakic, pseudophakic, aphakic
- Number of patient eyes with Intraocular inflammation [12 and 6 months prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)]
The following categories were reported: No history of IOI and endophthalmitis related to safety evaluation and panuveitis History of IOI and endophthalmitis related to safety evaluation and panuveitis History of IOI including panuveitis (excluding endophthalmitis related to safety evaluation) History of endophthalmitis related to safety evaluation History of panuveitis
- Number of patient eyes with the history of ocular inflammation (includes IOIs or panuveitis or endophthalmitis relevant to safety evaluation) [36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)]
The following categories were reported: History of anterior inflammation History of posterior inflammation No history of IOI or endophthalmitis related to safety evaluation or panuveitis History of IOI and/or endophthalmitis related to safety evaluation and/or panuveitis History of IOI including panuveitis (excluding endophthalmitis related to safety evaluation) History of endophthalmitis related to safety evaluation History of Panuveitis
- History of other IOI and endophthalmitis due to infections or other underlying disease [36, 12 and 6 months prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)]
The following categories were reported: No history of inflammation History of any ocular inflammation History of severe ocular inflammation History of anterior inflammation History of posterior inflammation History of IOI or endophthalmitis due to infections and other underlying disease (separate category)
- Number of patient eyes with prior Intraocular Inflammation (IOI) and/or prior Retinal vascular occlusion (RO) [12 months prior to the index date ( index date defined as the date of first brolucizumab injection)]
Included history of ocular inflammation or occlusion
- Number of patient eyes with Systemic inflammation / auto-immune history (in total and at the event level) [36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)]
The following categories were reported: Systemic vasculitis Rheumatoid arthritis SLE Multiple sclerosis Sarcoidosis Giant cell arteritis / Temporal arteritis HLA-B27 diseases Behcet/Behcet's disease Ankylosing Spondylitis Crohn Disease Drug Hypersensitivity Vogt-Koyanagi-Harada (VKH)
- Number of patient eyes with the Provider specialty [Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)]
The following types were included: Retina specialist, General ophthalmologist, Non-retina specialist, unknown
- Number of patient eyes with Concomitant ocular medications [36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)]
The following types were included: any corticosteroids [prednisone, prednisolone acetate, difluprednate, Kenalog, ozurdex, yutiq], biologics [adalimumab], cyclosporine, azathioprine, methotrexate, ganciclovir, acyclovir, valacyclovir, foscavir, trifluridine, mycophenolate, rituxan, vancomycin, prostaglandins
- Type of exam performed [30 days before or on first brolucizumab injection (index date)]
OCT, FA, CP - color photo or color fundus photo
- Number of eyes treated with brolucizumab [Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)]
The following types were included: OD [eye, right], OS [eye, left], Unspecified, Unilateral, Bilateral)
- Number of patient eyes with Anti-VEGF treatment-naive vs prior-treated [60 months prior to index ( index date defined as the date of first brolucizumab injection)]
Anti-VEGF treatment-naive vs prior-treated were measured at the eye-level
- Number of patient eyes with prior treatment status [60 months prior to index ( index date defined as the date of first brolucizumab injection)]
The following types were included: off-label bevacizumab, ranibizumab, aflibercept, unknown, treatment-naive
- Number of patient eyes with different prior anti-VEGF agents [60 months prior to index ( index date defined as the date of first brolucizumab injection)]
Following categories will be included : 0, 1, 2, ≥3
- Number of patient eyes with prior anti-VEGF agents (total, per anti-VEGF agent) [60 months prior to index ( index date defined as the date of first brolucizumab injection)]
Following categories will be included : Continuous Categorical: <6, 6 to <12, 12 to <24, ≥24
- Number of patient eyes with the Last injection inetrval [60 months prior to index ( index date defined as the date of first brolucizumab injection)]
Following categories will be included : Continuous (weeks) Categorical: <4, 4 to <6, 6 to <8, ≥8, <12, ≥12 weeks
- Duration of last anti-VEGF treatment (total, per anti-VEGF agent) [60 months prior to index ( index date defined as the date of first brolucizumab injection)]
Following categories will be included : All anti-VEGFs i. Continuous ii. Categorical: <6, 6 to <12, 12 to <24, ≥24 months Specific anti-VEGF iii. Continuous (days)
- Time since wet Age-related macular degeneration (AMD) diagnosis [36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)]
Patients were measured at the eye level
- Time since any Age-related macular degeneration (AMD) diagnosis [36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)]
Patients were measured at the eye level
- Time from last anti-VEGF injection to index date [60 months prior to index ( index date defined as the date of first brolucizumab injection)]
The following categories were measured: Continuous (days) Categorical (0-30, 31-60, 61-90, 91+ days)
- Number of ocular adverse events (AEs) [Post-index period defined as the 180 days following therapy initiation, excluding index date]
To assess the incidence of ocular AEs among patients treated with brolucizumab
Eligibility Criteria
Criteria
Inclusion criteria:
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≥1 Healthcare Common Procedure Coding System (HCPCS) code (J code) or National Drug Code (NDC) for treatment with brolucizumab during the index period (date of earliest code = index date)
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≥18 years old on the index date
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≥1 International Classification of Diseases, Clinical Modification-9/10 (ICD-9/10) code for wet AMD in the 36 months prior to or on the index date
- Note: Off-label use of brolucizumab is not expected given payer access restrictions in the US
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≥24 months of continuous enrollment prior to the index date
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≥1 follow-up visit related to their wet AMD after the index date
Exclusion criteria:
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Use of brolucizumab prior to 08-Oct-2019 (e.g. clinical trials)
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Unknown laterality of the index eye on the index date
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Patients with no data throughout the 12 months immediately prior to the index date
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | East Hanover | New Jersey | United States | 79361080 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CRTH258AUS21