A Study of Treatment Patterns and Real-World Outcomes in IgA Nephropathy Patients in the United States

Novartis Pharmaceuticals6,286 enrolled

Overview

The aim of this study was to characterize real-world treatment patterns, including therapy sequences, escalation, and duration, and treatment outcomes in IgA nephropathy (IgAN) patients in the United States (US). The study used data which has detailed information on renal biopsy and laboratory data, linked with medical and pharmacy claims.

Study Type

OBSERVATIONAL

Enrollment

6,286

Conditions

IGA Nephropathy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion criteria: IgAN Cohort: * Renal biopsy confirming IgAN during the patient identification period. * Age ≥18 at index. The index date was the date of first claim or biopsy. * ≥182 days of continuous enrollment in medical and pharmacy claims before index date. * ≥365 days of continuous enrollment in medical and pharmacy claims following (and including) index date. Treatment Escalation Cohort: * Renal biopsy confirming IgAN during the patient identification period. * Age ≥18 at index. * ≥182 days of continuous enrollment in medical and pharmacy claims before index date. * ≥182 days of continuous enrollment in medical and pharmacy claims following (and including) index date. * Evidence of treatment with a renin-angiotensin-aldosterone system inhibitor (RAASi) for \> 3 months following IgAN diagnosis date. * ≥1 urine protein creatinine ratio (UPCR) lab measurement following the index date. Exclusion Criteria: IgAN Cohort: • Presence of systemic lupus erythematosus (SLE), lupus nephritis (LN), IgA vasculitis (IgAV), chronic liver disease, and Minimal Change Disease (MCD) with IgA deposition at any time during the study period. Treatment Escalation Cohort: * Presence of SLE, LN, IgAV, chronic liver disease, and MCD with IgA deposition at any time during the study period. * Any evidence of kidney failure as defined by estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73 m², International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes for chronic kidney disease (CKD) stage 5, Current Procedural Terminology (CPT) codes for kidney transplant or dialysis prior to RAASi initiation. * Received any corticosteroids/mycophenolate mofetil (MMF), sodium-glucose co-transporter 2 inhibitor (SGLT2i), or IgAN branded therapies prior to the end of the 90 days of RAASi treatment.

Locations (1)

Novartis

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Proportion of Patients Treated With any Therapy at any Time During the Study Period

Time frame: 365 days

Among Patients that Received Treatment, Proportion of Patients Who Received any of the Drug Classes of Interest at any Time During the Study Period

Drug classes of interest include: * RAASi * Corticosteroids/glucocorticoids/MMF * SGLT2i * Targeted release budesonide * Sparsentan * Atrasentan * Iptacopan * Sibeprenlimab

Time frame: 365 days

Among Patients that Received Treatment, Number of Fills of the Drugs in Drug Classes of Interest

Drug classes of interest include: * RAASi * Corticosteroids/glucocorticoids/MMF * SGLT2i * Targeted release budesonide * Sparsentan * Atrasentan * Iptacopan * Sibeprenlimab

Time frame: 365 days

Among Patients that Received Treatment, Duration of Treatment With Drugs in Drug Classes of Interest

Drug classes of interest include: * RAASi * Corticosteroids/glucocorticoids/MMF * SGLT2i * Targeted release budesonide * Sparsentan * Atrasentan * Iptacopan * Sibeprenlimab

Time frame: 365 days

Duration of Each Line of Therapy (LOT)

Time frame: 365 days

For Each LOT, Number of Fills of Each Drug Class

Time frame: 365 days

For Each LOT, Percentage of Patients that Discontinue First-line (1L), Second-line (2L), and Third-line (3L) of Therapy

Time frame: 365 days

Among Patients Who Discontinue 1L, 2L, 3L Therapy, Time to Treatment Discontinuation

Time frame: 365 days

Data from ClinicalTrials.gov

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Secondary Outcomes

Proportion of Patients by Demographics, Clinical, and Laboratory Characteristics

Demographics, clinical, and laboratory characteristics include: * Age group * Sex * Race * Ethnicity * Insurance type * Charlson Comorbidity Index (CCI) group (0, 1, 2, 3+) * Comorbidities * Proteinuria category * Hematuria (yes/no) * Glomerular inflammation (yes/no)

Time frame: Baseline

Age at Index

Time frame: Baseline

Charlson Comorbidity Index (CCI) Score

CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be categorized as low (0-1) and high (≥2).

Time frame: Baseline

Proportion of Patients by Chronic Kidney Disease (CKD) Stage

CKD stages: * Stage 1: Normal or minimal kidney damage with normal GFR (eGFR ≥90 mL/min/1.73m²) * Stage 2: Mild decrease in GFR (eGFR 60-89 mL/min/1.73m²) * Stage 3a: Mild to moderate decrease in GFR (eGFR 45-59 mL/min/1.73m²) * Stage 3b: Moderate to severe decrease in GFR (eGFR 30-44 mL/min/1.73m²) * Stage 4: Severe decrease in GFR (eGFR 15-29 mL/min/1.73m²) * Stage 5: Kidney failure (eGFR \<15 mL/min/1.73m²)

Time frame: Baseline

eGFR

Time frame: Baseline

eGFR Slope

Time frame: Baseline

Proteinuria

Proteinuria assessed using UPCR.

Time frame: Baseline

Mesangial Hypercellularity, Endocapillary Hypercellularity, Segmental Glomerulosclerosis, Tubular Atrophy/Interstitial Fibrosis, Crescents (MEST-C) Score

MEST-C score is the histopathologic classification system used in IgAN kidney biopsies to describe key lesions associated with disease progression. It is part of the Oxford Classification and is recommended as part of IgAN assessment. It includes five components. All five components are scored by categorical values as listed below. A higher score indicates involvement or a relatively greater degree of involvement (i.e., more severe pathology). 1. Mesangial hypercellularity (M) * M0 (present in ≤50% of glomeruli) * M1 (present in \>50% of glomeruli) 2. Endocapillary hypercellularity (E) * E0 (Absent) * E1 (Present) 3. Segmental glomerulosclerosis (S) * S0 (Absent) * S1 (Present) 4. Tubular atrophy/interstitial fibrosis (T) * T0 (0-25% of cortical area) * T1 (26-50% of cortical area) * T2 (\>50% of cortical area) 5. Cellular crescents (C) * C0 (No crescents) * C1 (present in \<25% of glomeruli) * C2 (present in ≥25% of glomeruli)

Time frame: Baseline

Proportion of Patients Achieving Proteinuria <0.3 g/d

Time frame: 365 days

Proportion of Patients Achieving Proteinuria <0.5g/d

Time frame: 365 days

Proportion of Patients Treated With any Therapy at any Time During the Study Period, Categorized by Disease Management Goal Status

Disease management goal status is a binary variable, meaning patients achieved or did not achieve disease management.

Time frame: 365 days

Among Patients that Received Treatment, Proportion of Patients Who Received any of the Drug Classes of Interest at any Time During the Study Period, Categorized by Disease Management Goal Status

Time frame: 365 days

Among Patients that Received Treatment, Duration of Treatment With Drugs in Each Drug Class of Interest, Categorized by Disease Management Goal Status

Time frame: 365 days

Among Patients that Received Treatment, Number of LOTs Received, Categorized by Disease Management Goal Status

Time frame: 365 days

Among Patients that Received Treatment, Proportion of Patients by Most Common Treatment Sequences, Categorized by Disease Management Goal Status

Time frame: 365 days

Number of Steroid-related Adverse Events (AEs) per Patient per Year (PPPY)

Time frame: 365 days

Proportion of Patients with ≥1 Steroid-related AE

Time frame: 365 days

Proportion of Patients With ≥1 Steroid-related AE-related Outpatient, Inpatient, and Emergency Department Visit

Time frame: 365 days

Number of Steroid-related AE-related Outpatient, Inpatient, and Emergency Department Visits

Time frame: 365 days

Proportion of Patients With ≥1 ARB-related AE

Time frame: 365 days

Number of ARB-related AEs PPPY

Time frame: 365 days

Proportion of Patients With ≥1 ARB-related AE-related Outpatient, Inpatient, and Emergency Department Visit

Time frame: 365 days

Number of ARB-related AE-related Outpatient, Inpatient, and Emergency Department Visits

Time frame: 365 days

Among Patients Treated With RAASi Therapy Who had Elevated and Non-elevated Proteinuria, Proportion of Patients by Demographics and Clinical Characteristics

Demographics and clinical characteristics include: * Age group * Sex * Race * Ethnicity * Insurance type * Comorbidities

Time frame: Baseline

Among Patients Treated With RAASi Therapy Who had Elevated and Non-elevated Proteinuria, Age at Index

Time frame: Baseline

Among Patients Treated With RAASi Therapy Who had Elevated and Non-elevated Proteinuria, CCI Score

Time frame: Baseline

Proportion of Patients With Elevated Proteinuria Who Moved onto a Subsequent LOT Following the RAASi Containing LOT

Proportion of patients with treatment escalation.

Time frame: 182 days

Proportion of Patients Who Escalated to Another Drug, by Class of Drug

Drug classes include SGLT2is, immunosuppressants (corticosteroids and MMF), and IgAN branded therapy.

Time frame: 182 days

Proportion of Patients by Each Post-escalation Treatment Sequence

Time frame: 182 days

Time to Treatment Escalation for Patients With Elevated Proteinuria After Receiving Treatment With RAASi Therapy

Time frame: 182 days