Patient- and Physician-reported Satisfaction With Systemic Lupus Erythematosus Treatment in US Clinical Practice

Katie Pascoe,Steve Lobosco,David Bell,Ben Hoskin,David J Chang,Bonnie Pobiner,Sulabha Ramachandran

doi:10.1016/j.clinthera.2017.07.039

Abstract

PurposeThis two-part study comprised two descriptive, cross-sectional surveys to evaluate treatment satisfaction among patients with systemic lupus erythematosus (SLE) and their physicians from US clinical practices. The Lupus Plus Project (LPP; part one) involved belimumab-containing regimens; the Disease Specific Program (DSP; part two) included all treatments and was designed to build on the body of evidence from part one. MethodsThe LPP recruited patients receiving belimumab, and comprised 2 paper questionnaires: a patient self-completion questionnaire (PSC) and a patient record form (PRF) completed by the physician. The DSP enrolled patients with SLE receiving any treatment and comprised four parts: a PSC, a PRF completed by the physician after patient consultation, face-to-face physician interviews, and a workload form completed by the physicians to indicate their total SLE patient workload. The key objective of this study was to assess physician and patient satisfaction with current treatment. FindingsFrom the PSCs, data regarding patient-reported satisfaction with current treatment were available for 263 patients who were receiving belimumab combination therapy (LPP) and 250 patients who were receiving non-belimumab treatment (DSP). The majority of patients (belimumab, 86.3% [227/263]; non-belimumab, 78.4% [196/250]) responded positively (at least “somewhat satisfied”) when asked about current treatment satisfaction, as did physicians (belimumab, 82.9% [311/375]; non-belimumab, 74.3% [326/439]). In multivariate analysis, factors most strongly associated with patient-reported satisfaction for patients receiving belimumab were patient-reported improvements in leisure activities since taking belimumab (odds ratio [OR] = 4.66), physician-reported improvements in fatigue (OR = 3.72), patient-reported improvements in general symptoms (OR = 3.02), and pain/achiness (OR = 2.71). Physician satisfaction was associated with clinical outcome such as improvements in pain/achiness (OR = 6.16), fatigue (OR = 3.76), and patient-reported satisfaction with treatment frequency (OR = 3.91). In patients receiving other SLE treatments, dosing frequency of current treatment (OR = 3.64) and a reduction in fatigue severity (OR = 3.61) were most strongly associated with patient-reported satisfaction; physician satisfaction was most strongly associated with a reduction in fatigue (OR = 6.22) and current remission status (OR = 6.05). ImplicationsWhen considering SLE treatment satisfaction patients tend to consider impact on daily functioning, whereas physicians take into account a wider range of clinical outcomes; however, both strongly consider improvements in fatigue. These surveys provide insights into treatment satisfaction among prescribers and patients with SLE. GSK-ClinicalStudyRegister.com identifiers: GSK study 202146 [HO 15-15509] and 205086 [HO 15-16709].

Highlights

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with diverse manifestations, characterized by periods of remission and flare.[1,2] There is no cure for SLE; several classes of drugs are used to manage the disease, including corticosteroid (CS), antimalarial (AM), and immunosuppressant (IS) agents and non-steroidal anti-inflammatory drugs (NSAIDs).[3]Belimumab is a human IgG1λ monoclonal antibody approved for the treatment of adult patients with active, autoantibody-positive SLE who are receiving standard SLE therapy
This study reports data collected from the Adelphi Real World (ARW) Lupus Plus Project (LPP) and the Lupus Disease Specific Program (DSP) surveys
The DSP survey consisted of four parts: physician interviews conducted face to face with participating physicians, a patient record form (PRF) completed by the physician after a patient consultation, and a patient self-completion questionnaire (PSC)

Summary

Introduction

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with diverse manifestations, characterized by periods of remission and flare.[1,2] There is no cure for SLE; several classes of drugs are used to manage the disease, including corticosteroid (CS), antimalarial (AM), and immunosuppressant (IS) agents and non-steroidal anti-inflammatory drugs (NSAIDs).[3]Belimumab is a human IgG1λ monoclonal antibody approved for the treatment of adult patients with active, autoantibody-positive SLE who are receiving standard SLE therapy (referred to as standard of care [SoC]). Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with diverse manifestations, characterized by periods of remission and flare.[1,2] There is no cure for SLE; several classes of drugs are used to manage the disease, including corticosteroid (CS), antimalarial (AM), and immunosuppressant (IS) agents and non-steroidal anti-inflammatory drugs (NSAIDs).[3]. The safety profile and efficacy of belimumab have been reported in two Phase III studies, Belimumab in Subjects with Systemic Lupus Erythematosus (BLISS)-52 and BLISS-76, in patients with autoantibody-positive, active SLE.[4,5]. It is worthwhile to investigate physician and patient satisfaction with belimumab, to further evaluate the real-world benefit of belimumab plus SoC

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