Comparison of On-Label Treatment Persistence in Real-World Patients with Psoriatic Arthritis Receiving Guselkumab Versus Subcutaneous Interleukin-17A Inhibitors

Abstract

Introduction: Psoriatic arthritis (PsA) is a chronic, multidomain, inflammatory disease requiring long-term treatment. Guselkumab, a fully human interleukin [IL]-23p19-subunit inhibitor, and the IL-17A inhibitors (IL-17Ai) ixekizumab and secukinumab are approved by the US Food and Drug Administration (FDA) for adults with active PsA. Real-world data evaluating on-label treatment persistence is an important consideration for patients.

Methods: This retrospective claim-based analysis (IQVIA PharMetrics® Plus) included adults with PsA receiving guselkumab or their first subcutaneous (SC) IL-17Ai (ixekizumab/secukinumab) per FDA label ("on-label") between July 14, 2020, and June 30, 2022. Baseline demographic and disease characteristics were collected in the 12 months preceding the index date (date of first guselkumab or SC IL-17Ai claim); follow-up extended through the earlier of the end of continuous insurance eligibility or end of data availability. Baseline characteristics were balanced between the cohorts by propensity score weighting (standardized mortality ratio [SMR]). Discontinuation was defined as a gap 2 × the FDA-approved maintenance dosing interval (guselkumab:112 days; SC IL-17Ai: 56 days); on-label persistence in the weighted cohorts was assessed using Kaplan-Meier curves and compared with a Cox proportional hazards model.

Results: Weighted demographic and disease characteristics were well balanced between the cohorts (guselkumab: N = 910, mean age = 50.4 years, 60.4% female; SC IL-17Ai: N = 2740, mean age = 50.2, 59.4% female). At 12 months, the guselkumab cohort was 1.85 × more likely to remain persistent with on-label therapy vs the SC IL-17Ai cohort (p < 0.001); median time to discontinuation was not reached for guselkumab and was 12.3 months for SC IL-17Ai. At 3, 6, 9, and 12 months, persistence rates in the weighted cohorts were higher with guselkumab than with SC IL-17Ai (p < 0.001).

Conclusion: In this real-world claims data analysis in adults with PsA, on-label persistence rates were statistically significantly higher with guselkumab, as early as 3 months, with ~ 2 × greater likelihood of persistence at 12 months relative to SC IL-17Ai.

Keywords: Guselkumab; Persistence; Psoriatic arthritis; Real-world evidence; Subcutaneous interleukin-17A inhibitors.

Fig. 1

Study schema. ^aThe IQVIA™ Health Plan Claims Data is comprised of fully adjudicated claims for inpatient and outpatient services and outpatient prescription drugs, offering a diverse representation of geographic zones, employers, payers, providers, and therapy areas. ^bA validated algorithm for identifying patients with PsA in US claims data was used. ^cPatients could be biologic-naïve or biologic-experienced during baseline but were naïve to treatment with guselkumab or SC IL-17Ai (i.e., ixekinumab or secukinumab). ^dPatients in the SC IL-17Ai cohort were newly initiated within the class. ^eDiagnoses for PsA include claims on the index date and were identified based on ≥ 2 PsA diagnoses (ICD-10-CM code L40.5x) ≥ 30 days apart and ≥ 1 prescription claim for a PsA-related medication (i.e., guselkumab or SC IL-17Ai). GUS, guselkumab; ICD-10-CM, International Classification of Disease, 10th revision, Clinical Modification; PsA, psoriatic arthritis; SC IL-17Ai, subcutaneous interleukin-17A inhibitor

Fig. 2

Identification of the study population of patients with PsA receiving guselkumab or an SC IL-17Ai. ^aFirst guselkumab or SC IL-17Ai claim during intake period (July 14, 2020–June 30, 2022). ^bThe SC IL-17Ai cohort is defined as patients with an index claim for an SC IL-17Ai (i.e., ixekizumab or secukinumab). ^cNumbers of patients excluded sequentially among those remaining after the prior criterion was applied are reported. ^dBefore index date. ^eOn the index date. ^fRheumatic diseases included ankylosing spondylitis, other inflammatory arthritides, other spondylopathies, rheumatoid arthritis, systemic connective tissue disorders, relapsing polychondritis, or unclassified connective tissue disease occurring in the 12-month baseline period preceding the index date. Dx diagnosis, GUS guselkumab, PsA psoriatic arthritis, SC IL-17Ai subcutaneous interleukin-17A inhibitor

Fig. 3

Kaplan–Meier analysis of on-label persistence in weighted guselkumab and SC IL-17Ai cohorts^a: primary analysis (gap of twice the duration of time between administrations per FDA label). ^aPropensity score (standardized mortality ratio) weighting was used to obtain a balanced sample. Weights were estimated using a multivariable logistic regression model. Baseline covariates were age at index date; sex; region; insurance plan type; index year and half; relationship to primary beneficiary (e.g., self, spouse, child); presence of psoriasis (ICD-10:L40.x, excluding L40.5), other autoimmune diseases (inflammatory bowel disease^c), and comorbidities;^d Quan-Charlson comorbidity index; and prior use of non-narcotic analgesics, corticosteroids, opioids, and other PsA treatments.^e,f,g. ^bWeighted Cox proportional hazard model was used to compare risk of discontinuation between the GUS and SC IL-17Ai cohorts. ^cIncludes unclassified inflammatory bowel disease, Crohn’s disease, and ulcerative colitis. ^dCardiovascular disease (i.e., hypertension, hyperlipidemia, coronary artery disease, cerebrovascular disease, peripheral vascular disease), diabetes, smoking, and osteoarthritis. ^eInterleukin-12/23 inhibitor (ustekinumab), anti-cytotoxic T lymphocyte-associated antigen-4 agent (abatacept), interleukin-23p19-subunit inhibitor (risankizumab), subcutaneous tumor necrosis factor inhibitors (adalimumab, certolizumab pegol, etanercept, and golimumab), and intravenous tumor necrosis factor inhibitors (infliximab, infliximab biosimilars, and golimumab). The proportions of patients with 1 and ≥ 2 bDMARDs are reported among those with any bDMARD use. ^fMethotrexate, leflunomide, cyclosporine, mycophenolate, azathioprine, sulfasalazine, and hydroxychloroquine. ^gApremilast, deucravacitinib, and Janus kinase inhibitors (upadacitinib, baricitinib, and tofacitinib). bDMARD biologic disease-modifying anti-rheumatic drug, CI confidence interval, FDA Food and Drug Administration, GUS guselkumab, HR hazard ratio, ICD-10 International Classification of Diseases, Tenth Revision, SC IL-17Ai subcutaneous interleukin-17A inhibitor