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Abstract
Objective To investigate the real-world impact of intravenous belimumab treatment among patients with SLE using rheumatoid arthritis-derived disease activity measures and SLE-related laboratory values.
Methods This retrospective cohort study used US electronic medical record data from the United Rheumatology Normalised Integrated Community Evidence (UR-NICE) database. Adult patients with SLE who initiated intravenous belimumab between 1 January 2012 and 3 December 2019 (index), had 12 months of pre-index and 24 months of post-index clinical activity, and had ≥6 infusions of belimumab during the 24 months post-index were included. The primary outcome measure was time to first improvement of minimally important difference (MID) for Routine Assessment of Patient Index Data 3 (RAPID3), Patient Pain Index (PPI), swollen joint count, tender joint count (TJC), complement C3 and C4 and anti-double-stranded DNA antibodies during the on-treatment follow-up period of up to 24 months. The secondary outcome measure evaluated the trajectories of these outcome measures for up to 24 months of belimumab treatment.
Results Of 495 patients included, between 21.0% and 52.1% had ≥1 record for each of the disease activity measures or laboratory values in the pre-index and post-index periods and were included in analyses for that measure. The proportion of patients achieving MID for each measure increased rapidly within 3 months, with continued gradual improvement throughout the remaining on-treatment period, up to 24 months. After 6 months, 52.3% and 55.3% of patients had achieved MID in RAPID3 and PPI, respectively. Outcome measure trajectories indicated improved disease activity with belimumab treatment, particularly in RAPID3, TJC and laboratory values.
Conclusions In this real-world effectiveness study, belimumab therapy for SLE resulted in clinically meaningful improvements in rheumatoid arthritis-derived disease activity measures within 3 months of treatment, with patients who remained on belimumab therapy experiencing improvement even up to 24 months of observation.
- autoimmune diseases
- biological products
- lupus erythematosus, systemic
- outcome assessment, health care
Data availability statement
Data are available on reasonable request. Anonymised individual participant data and study documents can be requested for further research from https://www.gsk-studyregister.com/en/.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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WHAT IS ALREADY KNOWN ON THIS TOPIC
Rheumatoid arthritis-derived (RAD) activity measures are in use clinically to assess SLE disease activity; however, the effectiveness of belimumab, a human IgG1λ monoclonal antibody that inhibits B lymphocyte stimulator, has not been evaluated using these disease activity measures.
WHAT THIS STUDY ADDS
This study shows the real-world clinical effectiveness of belimumab in improving RAD activity measures during treatment, with greater evidence of a treatment effect from 6 months and a continued response for the duration of the on-treatment follow-up period (up to 24 months).
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
This study suggests that RAD activity measures, such as the Routine Assessment of Patient Index Data 3, are improved over time with persistent belimumab therapy and may be valuable adjuncts to SLE-specific measures.
Introduction
SLE is a complex, chronic autoimmune disorder affecting multiple organ systems, with a heterogeneous clinical presentation.1 Because of the heterogeneity of SLE manifestations, measuring disease activity in clinical practice can be quite challenging.1 2 Although clinical measures of SLE-specific disease activity such as the SLE Disease Activity Index (SLEDAI) are commonly used in randomised clinical trials, they involve multiple assessments and laboratory tests that require significant administrative time—a combination of factors that has limited practicality in routine clinical practice.3
As there is considerable symptomatic overlap between SLE and rheumatoid arthritis (RA), including musculoskeletal manifestations, pain, fatigue and burden of disease on daily functioning, some disease activity measures initially developed for RA may be useful for the clinical assessment of SLE in routine practice. Indeed, up to 95% and 92% of patients with SLE might be expected to experience musculoskeletal manifestations or have joint involvement, respectively, related to SLE.4 An observational analysis of the clinical utility of rheumatology disease activity measures in the USA found that measures such as the Patient Pain Index (PPI) and Routine Assessment of Patient Index Data 3 (RAPID3) are increasingly used in clinical practice to assess patients with SLE, including among patients without a comorbid RA diagnosis.5 Other measures such as swollen joint count (SJC) and tender joint count (TJC) are also in use, but less frequently.5
RAPID3 is a patient-reported outcome measure of disease activity developed for use with patients with RA; the measure includes a multidimensional health assessment questionnaire, a pain visual analogue scale and a patient global assessment of disease activity.6 While RAPID3 is typically used to assess disease status for RA,6 it has been shown to be a valid measure of disease activity in other rheumatic and autoimmune diseases, including SLE, and can serve as an adjunct to joint examinations; notably, this application of RAPID3 has been validated in the real-world rheumatology setting.7–14 Importantly, RAPID3 is a patient-centric measure that can be quickly completed by the patient and interpreted by the clinician without the need for laboratory measures.6 While TJC and SJC have not been validated in SLE, it is acknowledged that currently available SLE global indices such as SLEDAI-2K are insufficient to capture joint inflammatory status.15 16 Given that musculoskeletal manifestations are one of the most common symptoms of SLE, and considering their detrimental effect on quality of life, there is a need to capture joint involvement in SLE with a measure that is sensitive to change over time.15–17
While some rheumatologists may employ RA-derived (RAD) measures to assess disease activity in patients with SLE, it is not clear whether the effect of SLE-specific therapies in improving SLE outcomes can be fully captured by these measures. One such therapy is belimumab, a recombinant human IgG1λ monoclonal antibody that specifically binds to and inhibits soluble B lymphocyte stimulator (BLyS). Belimumab is approved for the treatment of autoantibody-positive SLE in both intravenous and subcutaneous formulations.18 The disease-modifying effects of belimumab have been established in placebo-controlled clinical trials using SLE-specific measures and laboratory assessments, and in real-world observational studies, where effectiveness in reducing disease activity, preventing new flares and organ damage, and enabling tapering of glucocorticoids have been demonstrated.19 20
Given the continued medical need for effective, practical tools to assess disease activity and monitor treatment response and effectiveness in patients with SLE, the objective of this study was to evaluate the effectiveness of belimumab for the treatment of SLE using non-SLE-specific RAD disease activity measures and SLE-related laboratory values in a real-world setting.
Methods
Study design
This was a retrospective cohort study (GSK study 214106) using real-world data from a large US rheumatology network electronic medical record (EMR) database—the United Rheumatology Normalised Integrated Community Evidence database (UR-NICE)—with data ranging from 1 January 2010 to 3 December 2021. The UR-NICE database contains de-identified longitudinal data from over 2 million active patients with an autoimmune condition from contributing practices, among a membership representing 25% of independently practising rheumatologists and over 273 practices and groups across 40 states.21 Clinical characteristics including rheumatology-specific disease activity measures, laboratory measures and medical history are captured for all patients consulting a rheumatologist in the UR-NICE network for any autoimmune condition.
The study design is summarised in online supplemental figure 1. The index date was defined as the first administration of intravenous belimumab between the identification period ranging from 1 January 2012 to 3 December 2019. The baseline period was defined as the 12-month period preceding the index date. The on-treatment period (follow-up) was defined as the time from the index date to discontinuation of belimumab or 24 months post-index, whichever occurred first. Discontinuation was defined as a gap of >60 days between the end of a belimumab administration (administration date plus treatment cycle length of 28 days) and the next administration, or between the end of the last belimumab administration and the end of clinical activity or data availability. Clinical activity was defined as the time between the first and last encounter with physician services in the database, including laboratory measures, prescriptions, diagnoses and procedures. The use of these data aligns with the purpose of use outlined in the terms and conditions of use of the UR-NICE database.
Supplemental material
Patient and public involvement
Patients and/or the public were not involved in the design, conduct, reporting, or dissemination plans of this research.
Patient population
Patients were included in the study if they received at least one infusion of belimumab (10 mg/kg intravenous) between 1 January 2012 and 3 December 2019; had ≥12 months of clinical activity prior to the index date; had ≥24 months of clinical activity after the index date; had at least one diagnosis of SLE (International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM): 710.0x; International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM): M32.1x, M32.8, M32.9) prior to or on the index date; and received ≥6 infusions of belimumab (10 mg/kg intravenous) during the 24 months post-index (including the index date). Patients were excluded if they received intravenous belimumab prior to the index date; were <20 years of age on the index date; had a diagnosis of drug-induced SLE prior to or on the index date (ICD-10-CM: M32.0); or received subcutaneous belimumab in the 12 months pre-index or 24 months post-index.
Variables and outcomes
Each study outcome was assessed among a distinct subgroup of patients with ≥1 record of the given RAD disease activity measure or SLE-related laboratory value during both the baseline and the 24 months post-index.
The primary outcome measure was time to first improvement greater than the minimally important difference (MID) for a selection of RAD disease activity and SLE-related laboratory values. The time to first decrease below the MID was assessed for the following measures: RAPID3 (weighted from a 30-point scale to 0–10), PPI (scale 0–10), SJC (scale 0–28), TJC (scale 0–28) and anti-double-stranded DNA (anti-dsDNA) antibodies; the time to first increase above the MID was assessed for complement C3 and complement C4.
The MID was calculated as 0.5 times the SD of the mean of all baseline measurements among patients in each subgroup, for each disease measure.22 A decrease below MID was defined as a score below the reference point for each patient minus the MID. An increase above MID was defined as a score above the reference point for each patient plus the MID. The reference point was defined as the mean baseline score for each patient. As a sensitivity analysis, the value closest to the index date during baseline was used as the reference point for the calculation of MID for each patient.
The secondary outcome measure described the trajectory (change in measure per year) of each RAD disease activity measure and SLE-related laboratory value during the baseline period and the on-treatment period, separately, among the given subgroup using all available measurements for that outcome. A sensitivity analysis assessed the trajectory of each outcome excluding the first 6 months post-index, when belimumab’s full effect may not yet be realised. This sensitivity analysis included only patients with ≥1 measurement from 6 months post-index to the end of the on-treatment period.
Patient information extracted from the UR-NICE database included demographics and clinical characteristics, comorbidities, medication history and the outcome measures listed above. Age was assessed at the time of index. Patient year of birth was only available in 5-year intervals; therefore, to calculate age at index, patients’ birthdays were imputed as 31 December of the lowest year of the 5-year interval. All other demographic information was assessed at time of data extraction (December 2021). Clinical characteristics, including medication use, comorbidities, RAD activity measures and SLE laboratory values were assessed during the baseline period.
Statistical analyses
For the primary outcome, the time to first decrease below MID (for RAPID3, PPI, SJC, TJC and anti-dsDNA antibodies), or increase above the MID (for complement C3 and complement C4), was assessed using Kaplan–Meier analysis during the on-treatment period. Kaplan–Meier rates of first decrease below MID or first increase above MID (as appropriate) were reported at fixed intervals during follow-up: 3, 6, 12, 18 and 24 months after the index date.
For the secondary outcome, longitudinal mixed effects models were used to assess trajectories of RAD disease measures and SLE-related laboratory values during the baseline and on-treatment periods. These models allowed the linear trajectory to change at the index date and accounted for the correlation of observations within individual patients due to repeated measurements. The mean change in each measure per year during the baseline and follow-up periods (ie, slopes before and after intravenous belimumab initiation), along with the change in slope at belimumab initiation, were calculated based on the model. Non-parametric bootstrap procedures were used to calculate 95% CIs and p values to evaluate the slope of the trajectory after belimumab initiation.
All other data are presented using descriptive statistics including mean, SD and median for the continuous variables, and frequencies and proportions for the categorical variables.
Results
Patient population
In total, 495 patients met the study eligibility criteria (online supplemental figure 2) and 396 were categorised into one or more subgroups dependent on which measures they had in the baseline and follow-up periods (subgroups were not mutually exclusive). Consequently, 104 (21.0%) were included in the RAPID3 subgroup, 258 (52.1%) in PPI, 148 (29.9%) in SJC, 144 (29.1%) in TJC, 252 (50.9%) in complement C3, 250 (50.5%) in complement C4 and 154 (31.1%) in anti-dsDNA antibodies; 99 patients (20.0%) were not included in any subgroup. The mean (SD) on-treatment period for all patients was 18.2 (6.9) months (table 1), with little variation between subgroups (online supplemental table 1). Overall, patients had a mean (SD) age of 47.7 (12.3) years at index, and the majority were female (95.4%). The most common race or ethnicity was white (46.5%), followed by black/African-American (19.4%). The majority of patients received corticosteroids (64.2%) during the baseline period, and 10.9% of patients had comorbid RA recorded (table 1). These characteristics were generally descriptively similar across subgroups (online supplemental table 1); however, the proportion of patients with RA varied from 9.1% in the anti-dsDNA antibodies subgroup to 17.4% in the TJC subgroup.
Overall population demographics and clinical characteristics
Outcomes
Primary outcome
The Kaplan–Meier rates of first increase above, or decrease below, the MID at each time point are presented in figure 1 for RAD disease activity measures and figure 2 for SLE-related laboratory values more traditionally used to diagnose and monitor patients with SLE. The proportion of patients achieving a meaningful improvement in RAD disease activity measures increased within 3 months of belimumab treatment for all measures and continued to increase throughout the on-treatment period (figure 1). The measures with the greatest proportion of patients experiencing an improvement by the end of the on-treatment period were RAPID3 (60.8%) and PPI (75.5%), with more than half of patients achieving MID after 6 months of persistent belimumab treatment (RAPID3, 52.3%; PPI, 55.3%). Similarly, the proportion of patients achieving MID in the SLE-related laboratory values increased within 3 months of belimumab treatment for all measures and continued to increase throughout the on-treatment period (figure 2). Sensitivity analysis results using an MID based on the most recent baseline values were consistent with the primary analysis based on the mean baseline value (online supplemental table 2).
Proportion of patients achieving MID* for (A) RAPID3, (B) PPI, (C) SJC and (D) TJC RAD disease measures after initiation of belimumab (10 mg/kg intravenous; patients still on treatment; Kaplan–Meier analysis). *The MID was defined as 0.5 times the SD for the mean of baseline values; †number of patients still observed at the specific point in time; ‡median time represents the time point when 50% of patients had experienced at least one decrease below or increase above the MID for a given outcome. MID, minimally important difference; PPI, Patient Pain Index; RAD, rheumatoid arthritis-derived; RAPID3, Routine Assessment of Patient Index Data 3; SJC, swollen joint count; TJC, tender joint count.
Proportion of patients achieving MID* for (A) complement C3, (B) complement C4 and (C) anti-dsDNA antibodies laboratory values after initiation of belimumab (10 mg/kg intravenous; patients still on treatment; Kaplan–Meier analysis). *The MID was defined as 0.5 times the SD for the mean of baseline values; †number of patients still observed at the specific point in time; ‡median time represents the time point when 50% of patients had experienced at least one decrease below or increase above the MID for a given outcome. Anti-dsDNA, anti-double-stranded DNA; MID, minimally important difference.
Secondary outcome
Excluding the first 6 months after index, when the full treatment effect of belimumab may not yet have been evident, trajectories for all outcome measures improved with belimumab treatment (figures 3 and 4). Considerable improvements during belimumab treatment were seen for RAPID3 (score decrease per year −0.29; 95% CI −0.57 to –0.04), TJC (score decrease per year −1.11; 95% CI −1.91 to –0.35), anti-dsDNA antibodies (decrease per year (IU/mL) −16.65; 95% CI −31.68 to –4.09), complement C3 (increase per year (mg/dL) 5.60; 95% CI 3.37 to 7.80) and complement C4 (increase per year (mg/dL) 1.92; 95% CI 1.13 to 2.75) trajectories. When the first 6 months of belimumab treatment were included, outcome trajectories were directionally similar, but the treatment effect was generally more evident for the SLE-related laboratory values (figure 4) than RAD disease activity measures (figure 3). Notable improvements in TJC (score decrease per year −0.90; 95% CI −1.45 to –0.32), complement C3 (increase per year (mg/dL) 5.42; 95% CI 3.39 to 7.67) and complement C4 (increase per year (mg/dL) 2.12; 95% CI 1.41 to 2.83) trajectories were evident.
Changes in (A) RAPID3, (B) PPI, (C) SJC and (D) TJC RAD disease measure trajectories* in the 12 months before and 24 months after initiation of belimumab (10 mg/kg intravenous; patients still on treatment). *Estimates were derived from linear mixed effects models controlling for repeated measurements within patients. CIs, represented by dotted lines in the figure, were calculated using non-parametric bootstrap procedures with 999 replications. PPI, Patient Pain Index; RAD, rheumatoid arthritis-derived; RAPID3, Routine Assessment of Patient Index Data 3; SJC, swollen joint count; TJC, tender joint count.
Changes in (A) complement C3, (B) complement C4 and (C) anti-dsDNA antibodies laboratory value trajectories* in the 12 months before and 24 months after initiation of belimumab (10 mg/kg intravenous; patients still on treatment). *Estimates were derived from linear mixed effects models controlling for repeated measurements within patients. CIs, represented by dotted lines in the figure, were calculated using non-parametric bootstrap procedures with 999 replications. Anti-dsDNA, anti-double-stranded DNA; SJC, swollen joint count; TJC, tender joint count.
Discussion
In this large, real-world EMR database study, RAD disease activity measures were used for 21.0%–52.1% of patients with SLE, with PPI used most frequently. The adoption of these tools for the management of SLE in clinical practice suggests that clinicians may find it practical to incorporate them into patient assessments, adjunctive to currently available SLE-specific measures (such as SLEDAI and British Isles Lupus Assessment Group), which are more time-consuming, require additional testing or may not include patient-reported outcomes.3 23 24
The results of this analysis in patients with SLE receiving belimumab also demonstrated that RAD disease activity measures can capture the effectiveness of SLE therapies; meaningful improvements in outcomes assessed by these measures were evident within 3 months of belimumab treatment, with continued improvement over 24 months in patients who remained on therapy. These sustained improvements are consistent with existing real-world evidence with different disease indices. In a meta-analysis of real-world SLE studies, treatment with belimumab was associated with a 57% reduction in SLEDAI scores and a 43% reduction in prednisone-equivalent dosing over 6 months, and a 66% reduction in flare frequency over 12 months.25 Improvements in SLEDAI score and prednisone-equivalent dosing were maintained over the 24 months observed in patients who continued therapy.25 Although greater decreases in mean SLE-related disease activity scores are generally seen in the first 6 months of treatment than the months following,25 some patients may not experience a response unless treatment persists beyond this time point,26 27 particularly patients who initiate belimumab later in their disease course.26 In another observational analysis of patients with long-standing disease, most patients treated with belimumab demonstrated a gradual decrease in SLEDAI-2K score over 6–12 months while a minority experienced a rapid decrease over 3–6 months.28 In the present study, the proportion of patients who achieved improvements in RAD disease activity measures increased the most within the first 6 months. However, the proportion continued to increase for the remainder of the on-treatment follow-up period, and trajectory analyses suggest that the full treatment benefit of belimumab continues to be evident after the first 6 months, according to RAD disease activity measures. This observation supports the suggestion that there is a role for treatment continuation for an extended period to assess belimumab effectiveness in individual patients.26 27
It is notable that belimumab did not demonstrate efficacy for patients with RA in a clinical trial assessing improvement in American College of Rheumatology response criteria.29 Belimumab’s lack of efficacy in RA indicates that, regardless of the overlap in RA comorbidity noted in the present analysis, the benefit identified in patients with SLE is unlikely to be derived from treating underlying RA-related pathology given the results of prior trials that reflected no benefit from belimumab for patients with RA without SLE.29
An increase in the proportion of patients achieving an MID over time with continued therapy was also observed in laboratory values that are typically used in SLE, particularly in complement C3 and C4 measures, where 8.7% and 8.8% had improvements beyond MID at month 3 and 59.0% and 49.3% had improvements beyond MID at month 24, respectively. In contrast to the delay seen in the RAD disease activity trajectories, the trajectory analyses of complement C3 and C4 suggest that these measures are improved soon after belimumab treatment, which is consistent with reporting in other real-world evidence and clinical trials30–32; however, clinical improvement may not correlate with improvement in complement C3 and C4.
While a response to belimumab was evident in the RAD disease activity measures assessed, further validation may be required to ensure that the measures fully reflect the specific needs of patients with SLE. RAPID3 has been validated for RA but may lack some aspects that are important to patients with SLE. Furthermore, RAPID3, like other patient-reported outcomes, may not align with SLE-specific disease activity measures such as SLEDAI.7 However, clinical adoption of these tools indicates that they may offer complementary features, such as patient-reported outcomes, to the available SLE-specific disease activity measures that are valued by clinicians.
The selection of appropriate disease monitoring measures and targets in SLE to inform treatment decisions has been discussed extensively with the introduction of the treat-to-target approach for SLE.33 While lupus low disease activity state (LLDAS) and Definitions Of Remission In SLE (DORIS) have achieved international consensus as treatment targets, there are practical considerations for clinical application.34 35 When considering LLDAS as a target to inform treatment decisions, it is notable that SLEDAI-2K and SELENA-SLEDAI physician global assessment scores are advised, and that these measures result in considerably greater administrative burden than the RAD disease activity measures discussed here. Additionally, LLDAS does not include any patient-reported outcomes, and in itself may not be an optimal target from a patient’s perspective when considering health-related quality of life.24 In contrast, RAPID3 and PPI incorporate the patient perspective into the evaluative process of disease improvement, aiding in a more robust understanding of the patient’s progress than laboratory or physician-reported measures alone. As RAD disease activity measures such as RAPID3 offer quicker disease activity assessment and incorporation of the patient’s perspective into care decisions, they offer important practical advantages over SLE-specific measures such as SLEDAI-2K, despite not being disease specific. SLE-specific patient-reported outcome measures, such as a Systemic Lupus Activity Questionnaire (SLAQ), have been developed to assess patient-reported disease activity without laboratory measures; however, this tool is more suited to screening for flares than as part of routine clinical management.23 36 Patients’ SLAQ scores are calculated from the presence or absence of symptoms and do not account for improvement or worsening of a persistent symptom, whereas the RAPID3 multidimensional health assessment scoring incorporates a Likert scale, which accounts for symptom severity, offering potential benefit even though it is not disease specific.23 37 Additionally, RAPID3 and SLAQ scores have been demonstrated to be significantly correlated, most notably when inflammatory symptoms are predominant.10 Belimumab treatment aims to reduce inflammatory symptoms; thus, the RAPID3 response captured in the present study supports proper application and monitoring of on-target responses according to the intended use of belimumab.
Beyond assessing patient needs, patient-reported outcomes and readily applicable disease activity monitoring methods are valuable tools to create patient-clinician dialogue and the opportunity for patient empowerment and shared decision-making. Hurried or poor physician communication with patients has been associated with persistent medication non-adherence and worse SLE disease outcomes, particularly for minority populations.38 39 The use of relatively quick RAD disease activity assessments that include patient-reported outcomes but do not require laboratory results may be useful adjuncts to SLE-specific measures to provide opportunities for shared decision-making during the patient’s clinical visit.
There are several limitations to the present analyses. As is the case with all retrospective analyses of data repositories, the analyses are only as robust as the data recorded in the EMR and captured in the repository. However, as UR-NICE is a prominent rheumatology EMR database in the USA, capturing data from all patients seen by the participating independent rheumatologist practices in the network, it is considered a robust source of real-world clinical data. The proportion of patients with lupus nephritis (LN) was 2.8%, which may be lower than the proportion of belimumab-treated patients with LN currently. However, the study period concluded in 2019 before the indication of belimumab for LN in 202020; this low proportion of patients with LN is expectedly lower versus the post-LN indication for belimumab. Since all data are from rheumatology clinics, it is not possible to ascertain what additional baseline medications patients may have been receiving in other care settings, and the results may not be representative of all patients with SLE in the USA, who may be receiving care in other settings including rheumatology clinics which do not contribute data to UR-NICE. Additionally, comorbidities were determined by the presence of ICD-9/ICD-10 diagnosis codes, possibly resulting in misclassification bias in baseline comorbidities if a physician recorded a diagnosis code in a medical encounter as rule-out criteria. Because all patients were required to have ≥6 belimumab administrations, assessment of laboratory and clinical measures was based on patients with complete data on the relevant tests or records, and on-treatment analysis included only those who were adherent to therapy at the time of the measurement; therefore, the results may not be representative of the full population of both adherent and non-adherent patients with SLE treated with belimumab. Comorbidities may be underestimated as they were only captured using ICD-9/ICD-10 diagnosis codes and diagnoses recorded in rheumatology clinical practices.
Conclusions
Overall, this study with belimumab therapy indicates that RAD disease activity measures may be a valuable adjunct to SLE-specific measures in the clinical assessment of SLE disease activity and patient needs, and they can be used to document persistent improvements in disease measures over time. The clinically meaningful improvements in RAD disease activity measures within 3 months of persistent belimumab treatment, with improvement most evident after 6 months and persisting up to 24 months for those with continued adherence to therapy, suggests that RAD disease activity measures may be another tool for clinicians to monitor their patients with SLE.
Data availability statement
Data are available on reasonable request. Anonymised individual participant data and study documents can be requested for further research from https://www.gsk-studyregister.com/en/.
Ethics statements
Patient consent for publication
Ethics approval
This was a retrospective EMR database study that did not involve direct patient contact or primary collection of patient data, and omitted patient identification, informed consent and ethics committee/institutional review board approvals were not required.
Acknowledgments
Medical writing and submission support was provided by Claire Barron, MSc, of Fishawack Indicia, UK, part of Avalere Health, and was funded by GSK. A summary of these data was presented as a poster at the State of Texas Association of Rheumatologists Annual Meeting, 2023.
References
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
Contributors GG, KW, SDM, BR, CFB, FL, AU and MSD contributed to the conception and design of the study, GG and FL contributed to the acquisition of data. GG, SDM, FL, AU and MSD contributed to data analysis, and all authors contributed to data interpretation and drafting and critically revising the manuscript for intellectual content. KW is responsible for the overall content as guarantor.
Funding This study was funded by GSK (GSK study 214106).
Competing interests KW, CFB and BR are employees of GSK and hold shares in the company. GG, FL, SDM, AU and MSD are employees of Analysis Group, a consulting company that received research funds from GSK to conduct this study. AC is chief innovation officer at Exagen and is EVP, Chief Medical Officer at United Rheumatology, which is the source of the data for this study.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Author note (AU) At the time of study.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.