Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)

Novartis Pharmaceuticals9,261 enrolled

Overview

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.

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. * 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. * Index date: Defined as the date of the earliest brolucizumab injection during the index period. * 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 Type

OBSERVATIONAL

Enrollment

9,261

Conditions

Age-related Macular Degeneration (AMD)

Interventions

BrolucizumabDRUG

Participants received brolucizumab injection during the index period

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. ≥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) 2. ≥18 years old on the index date 3. ≥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 4. ≥24 months of continuous enrollment prior to the index date 5. ≥1 follow-up visit related to their wet AMD after the index date Exclusion criteria: 1. Use of brolucizumab prior to 08-Oct-2019 (e.g. clinical trials) 2. Unknown laterality of the index eye on the index date 3. Patients with no data throughout the 12 months immediately prior to the index date

Locations (1)

Novartis Investigative Site

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Number of patient eyes with an Intraocular Inflammation (IOI) event during the first 6 months

To assess IOI events observed after starting treatment with brolucizumab

Time frame: Up to 6 months post brolucizumab injection

Secondary Outcomes

Age

Age information was reported

Time frame: 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

Gender information was reported

Time frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)

Number of patients at various Patient Region

Patient regions: Northeast, Midwest, South, West, Unknown

Time frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)

Number of patients with Insurance type

Insurance type: Private, Medicare, Medicare Advantage, Medicaid, Other

Time frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)

Number of patients with Laterality of wet Age-related macular degeneration (AMD)

Laterality of wet AMD: Unilateral, Bilateral

Time frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)

Number of patients with Laterality of any Age-related macular degeneration (AMD)

Data from ClinicalTrials.gov

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Laterality of wet AMD: Unilateral, Bilateral

Time frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)

Number of eyes with the concurrent eye disease

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

Time frame: Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)

Number of patient eyes with previous ocular surgeries or procedures

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

Time frame: Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)

Number of patient eyes with systemic comorbidities

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

Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)

Number of Concomitant systemic medications (chronic use)

Types: * Corticosteroids * Systemic anti-VEGFs * Lipid lowering agents * Antihypertensives * Biologics * Antimetabolites/cancer therapy * Anticoagulants

Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)

Number of patient eyes with the Cataract status

Types: phakic, pseudophakic, aphakic

Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)

Number of patient eyes with Intraocular inflammation

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

Time frame: 12 and 6 months prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)

Number of patient eyes with the history of ocular inflammation (includes IOIs or panuveitis or endophthalmitis relevant to safety evaluation)

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

Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)

History of other IOI and endophthalmitis due to infections or other underlying disease

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)

Time frame: 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)

Number of patient eyes with prior Intraocular Inflammation (IOI) and/or prior Retinal vascular occlusion (RO)

Included history of ocular inflammation or occlusion

Time frame: 12 months prior to the index date ( index date defined as the date of first brolucizumab injection)

Number of patient eyes with Systemic inflammation / auto-immune history (in total and at the event level)

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)

Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)

Number of patient eyes with the Provider specialty

The following types were included: Retina specialist, General ophthalmologist, Non-retina specialist, unknown

Time frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)

Number of patient eyes with Concomitant ocular medications

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

Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)

Type of exam performed

OCT, FA, CP - color photo or color fundus photo

Time frame: 30 days before or on first brolucizumab injection (index date)

Number of eyes treated with brolucizumab

The following types were included: OD \[eye, right\], OS \[eye, left\], Unspecified, Unilateral, Bilateral)

Time frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)

Number of patient eyes with Anti-VEGF treatment-naive vs prior-treated

Anti-VEGF treatment-naive vs prior-treated were measured at the eye-level

Time frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)

Number of patient eyes with prior treatment status

The following types were included: off-label bevacizumab, ranibizumab, aflibercept, unknown, treatment-naive

Time frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)

Number of patient eyes with different prior anti-VEGF agents

Following categories will be included : 0, 1, 2, ≥3

Time frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)

Number of patient eyes with prior anti-VEGF agents (total, per anti-VEGF agent)

Following categories will be included : * Continuous * Categorical: \<6, 6 to \<12, 12 to \<24, ≥24

Time frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)

Number of patient eyes with the Last injection inetrval

Following categories will be included : * Continuous (weeks) * Categorical: \<4, 4 to \<6, 6 to \<8, ≥8, \<12, ≥12 weeks

Time frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)

Duration of last anti-VEGF treatment (total, per anti-VEGF agent)

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 frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)

Time since wet Age-related macular degeneration (AMD) diagnosis

Patients were measured at the eye level

Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)

Time since any Age-related macular degeneration (AMD) diagnosis

Patients were measured at the eye level

Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)

Time from last anti-VEGF injection to index date

The following categories were measured: * Continuous (days) * Categorical (0-30, 31-60, 61-90, 91+ days)

Time frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)

Number of ocular adverse events (AEs)

To assess the incidence of ocular AEs among patients treated with brolucizumab

Time frame: Post-index period defined as the 180 days following therapy initiation, excluding index date