Patient perceptions and preferences of biologic therapies in SLE.

OBJECTIVE: To evaluate patient perceptions of biologic therapies from a large, population-based cohort of patients with SLE with significant numbers of blacks and whites and across the full spectrum of socioeconomic strata and disease severity. METHODS: This was a cross-sectional study of validated patients with SLE enrolled in the Georgians Organized Against Lupus Cohort between September 2014 and August 2015. The survey instrument was developed ad hoc by the authors and contained an introduction on biologics. RESULTS: A total of 676 participants were on average 48.4 years old with 15.9 years of disease; 93.2% were female and 80.6% were black; 34.2% had private health insurance and 9.8% had no insurance; and 26.8% and 27.5% had Medicare or Medicaid, respectively. Of all respondents, 30.8% had heard of biologics, with a significant difference between blacks and whites (25.2% vs 53.4%, respectively). There were no significant differences, however, between blacks and whites with respect to ever having been on biologics (7.6% and 11.5%, respectively) or where they got their information about biologics. Out of 202 individuals who had heard of biologics, 102 (51.3%) were familiar with potential benefits or side effects, and most (n=129, 66.5%) had a neutral perception to risks associated with biologic use. There was no perception of biologics working differently between races/ethnicities. More (n=76, 62.8%) blacks preferred intravenous over subcutaneous modalities compared with whites (n=12, 37.5%) but were not as willing to pay as much out of pocket for it. Individuals with Medicare were significantly more likely to have been on biologics. CONCLUSIONS: There are important similarities and differences between blacks and whites with lupus with respect to their perceptions of biologic therapies and their impact. There are opportunities to increase patient exposure to information about biologics and improve their understanding in order for them to make the best informed decision possible.

Physician-patient interactions in African American patients with systemic lupus erythematosus: Demographic characteristics and relationship with disease activity and depression.

OBJECTIVE: African American patients with systemic lupus erythematosus (SLE) are at high risk for poor outcomes. Both patient characteristics and the severity of the disease may influence physician-patient interactions, which in turn can impact disease outcomes. We aimed to examine whether patient perceptions of interpersonal processes of care (i.e. physician-patient interactions) varied by demographic characteristics, disease activity, and/or depression in African American patients with SLE. METHODS: The Georgians Organized Against Lupus (GOAL) is a cohort drawn from a population-based registry of people with SLE. We conducted a cross-sectional analysis of patient-reported data collected in 2016-17 among 698 African American participants (out of 863 GOAL participants). We assessed physician-patient interactions (communication, patient-centered decision making, and physician interpersonal style) through the Interpersonal Processes of Care survey (IPC-29), disease activity through the Systemic Lupus Activity Questionnaire, and depression through the Patient Health Questionnaire-9. Mean scores of the IPC-29 scales were compared by gender, age and educational attainment with Wilcoxon rank-sum 2-sample test or Kruskal Wallis test. We conducted linear trend test to examine demographic-adjusted scores of IPC across severity of disease activity and depression, and multivariate logistic regression analyses to examine the association of disease activity and depression with suboptimal IPC scores. RESULTS: Overall, the lowest mean scores were observed for the patient-centered decision making domain, and specifically about how often doctors assessed patients' problems to follow recommendations and treatment among females compared with males (mean scores 3.13 ±â€¯1.42 and 3.64 ±â€¯1.38, respectively; p = 0.015). Mean scores for the assumed socioeconomic level subdomain (how often doctors make assumptions about a patient's socioeconomic level) were worse in individuals aged 18-34 (mean score 1.59 ±â€¯0.94), compared to those aged 35-55 (mean score 1.47 ±â€¯0.94; p = 0.033). Patients with some college or higher educational attainment reported poorer mean scores for most communication and interpersonal style scales than those who reported high-school or less. We found significant linear trends of poorer scores for all communication scales across more severe disease activity and depression symptoms, and poorer scores for all interpersonal style scales across more severe disease activity. Multivariate models revealed that while depression was associated with suboptimal quality of both communication (OR 1.20; 95% CI 1.04-1.39) and interpersonal style (OR 1.12; 95% CI 1.01-1.25), disease activity only increased the odds of suboptimal interpersonal style (OR 1.13; 95% CI 1.03-1.25). CONCLUSION: In the African American population with SLE, suboptimal interactions with providers may be explained in part by the mental and physical symptoms of the patient, regardless of age, gender and education. In addition to standard of care treatment, SLE patients with more severe disease activity and depression might need provider-based interventions focused on communication and interpersonal style.

Clinical response beyond the Systemic Lupus Erythematosus Responder Index: post-hoc analysis of the BLISS-SC study.

OBJECTIVE: The Systemic Lupus Erythematosus (SLE) Responder Index (SRI), developed as a primary outcome measure for use in clinical trials, captures improvement in SLE disease activity without concomitant worsening in disease manifestations. This study investigated the relationships between the SRI and clinical/laboratory correlates of SRI response in patients with SLE. METHODS: This was a post-hoc analysis of the phase III, double-blind, placebo-controlled study of subcutaneous BeLimumab in Subjects with Systemic lupus erythematosus - SubCutaneous (BLISS-SC). Patients were randomised to weekly belimumab 200 mg subcutaneously or placebo, plus standard SLE therapy. Changes from baseline to week 52 in clinical and laboratory parameters were compared among SRI responders and non-responders, irrespective of the treatment received. RESULTS: SRI responders (n=475) had significantly better (p<0.0001) outcomes compared with non-responders (n=358), including (by definition) higher proportions achieving ≥4-point improvement in Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (100.0% vs 2.0%), no worsening in British Isles Lupus Assessment Group (BILAG; 0 new BILAG A or ≤1 new BILAG B score; 100.0 % vs 50.3%) and no worsening (<0.3-point increase) in Physician's Global Assessment score (100.0% vs 49.7%). Among patients receiving >7.5 mg/day corticosteroids at baseline, significantly more SRI responders had reductions in prednisone dose to ≤7.5 mg/day than non-responders. SRI responders reported lower flare rates and improvements in serological markers and Functional Assessment of Chronic Illness Therapy-Fatigue score than non-responders. CONCLUSION: SRI response is associated with improvements in clinical and laboratory measures, strengthening its value as a clinically meaningful primary endpoint in clinical trials.

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

PURPOSE: This 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. METHODS: The 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. FINDINGS: From 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). IMPLICATIONS: When 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].

External Validation of the Lupus Impact Tracker in a Southeastern US Longitudinal Cohort With Systemic Lupus Erythematosus.

OBJECTIVE: To examine the external validity of the Lupus Impact Tracker (LIT), a systemic lupus erythematosus (SLE)-specific, health-related quality of life (HRQoL) tool in a population-based cohort of patients with SLE in Atlanta, Georgia. We modeled the association of LIT scores with patient-reported measures of SLE activity (Systemic Lupus Activity Questionnaire [SLAQ]) and organ damage (self-administered Brief Index of Lupus Damage [SA-BILD]). We investigated the association of LIT scores with general HRQoL using the Short Form 12 (SF-12). METHODS: Correlation, multivariable regression, and longitudinal analyses using general linear modeling with fixed effects were performed to investigate the association between the LIT and patient-reported disease activity (SLAQ); patient-reported disease damage (SA-BILD); mental health (mental component summary [MCS] of the SF-12); and physical health (physical component summary [PCS] of the SF-12). Demographic trends related to the LIT were also assessed using cross-sectional analysis. RESULTS: The LIT was significantly associated with disease activity (SLAQ), organ damage (SA-BILD), MCS scores, and PCS scores in both adjusted and unadjusted regression analysis (P < 0.0001). Longitudinal analysis demonstrated a significant association between the LIT and disease activity (SLAQ), MCS scores, and PCS scores (P < 0.0001), but not organ damage (SA-BILD). CONCLUSION: The LIT is a simple, patient-centered tool that can be used to assess HRQoL in patients with SLE. This study provides external validity of the LIT in a population-based cohort with a large number of African American patients with a relatively high disease burden.

Ranitidine (Zantac) syrup versus Ranitidine effervescent tablets (Zantac) EFFERdose) in children: a single-center taste preference study.

BACKGROUND: The histamine H(2) receptor antagonist ranitidine is US FDA-approved for the treatment of gastroesophageal reflux disease and healing of erosive esophagitis in children >or=1 month of age. A low-dose strength of ranitidine is now available in a citrus-flavored 25 mg effervescent tablet (dissolved in 5 mL of water); this formulation was developed to facilitate use in infants and smaller children. Ranitidine syrup is available in a peppermint-flavored 15 mg/mL formulation. OBJECTIVE: To compare taste preferences for ranitidine (Zantac) syrup and ranitidine effervescent tablets dissolved in water (Zantac EFFERdose) in healthy children aged 4-8 years and their adult caregivers. STUDY DESIGN AND METHODS: A randomized, single-blind, crossover, taste test trial was conducted in 102 children and 102 parents/legal guardians. All subjects received a single 45 mg dose of each formulation. After tasting both preparations children were asked: "Now that you have tasted both medicines, which one of these medicines do you think tastes better?" Adults were asked four questions to assess whether they would administer the medication to the children. RESULTS: Seventy-one percent (72/102) of the children preferred the taste of the ranitidine effervescent tablets compared with 29% (30/102) who preferred the syrup (p < 0.001). The majority of adults (71%) responded that they would prefer to administer the effervescent formulation based on taste. Adverse events consistent with product labeling were mild and were reported in four children and three adults: headache (n = 3), drowsiness (n = 1), abdominal pain/cramps (n = 2), and bloating/gas (n = 1). CONCLUSION: The taste of the ranitidine effervescent formulation dissolved in water is preferred over the ranitidine syrup. Better taste acceptance may facilitate ease of administration and compliance in pediatric patients.

Abacavir, efavirenz, didanosine, with or without hydroxyurea, in HIV-infected adults failing initial nucleoside/protease inhibitor-containing regimens.

BACKGROUND: Hydroxyurea (HU) is an immunomodulatory agent that has been documented to enhance the antiretroviral activity of nucleoside reverse transcriptase inhibitors, such as abacavir (ABC) and didanosine (ddI), and would be expected to improve virologic efficacy. METHODS: A 48-week, phase IV, multicenter, open-label, proof-of-concept clinical trial was conducted to evaluate second-line, protease inhibitor (PI)-sparing therapy with ABC/efavirenz (EFV)/ddI plus HU or without HU in HIV-infected subjects failing to achieve HIV-1 RNA < or = 400 copies/mL after > or = 16 weeks of treatment with lamivudine/zidovudine or lamivudine/stavudine, plus 1 or 2 PIs. Subjects were assigned to ABC (300 mg twice daily)/ EFV (600 mg once daily)/ ddI (400 mg once daily) plus HU (500 mg twice daily) (n = 30) or this regimen without HU (n = 24). RESULTS: Baseline mean HIV-1 RNA was 3.86 log10 copies/mL and CD4+ cell count was 345 cells/mm3. A similar percentage of subjects in the non-HU arm (58%) and HU arm (53%) completed the study. Intent-to-treat: missing = failure analysis showed no differences in proportions of subjects in the non-HU and HU arms achieving undetectable plasma HIV-1 RNA levels at week 24 (< 400 copies/mL: 58% [14/24] vs 57% [17/30], P = 0.899; < 50 copies/mL (50% [12/24] vs 47% [14/30], P = 0.780). Median change from baseline in CD4+ cell count in the non-HU and HU arms at week 48 was +114 cells/mm3 and -63 cells/mm3 (P = 0.007), respectively. Both regimens were generally well tolerated, although more subjects in the HU arm withdrew prematurely from the study due to adverse events (23% vs 4%). Four cases of possible ABC-related hypersensitivity were observed. CONCLUSION: ABC/EFV/ddI was an effective and well-tolerated second-line regimen for nucleoside/PI-experienced HIV-infected subjects. The addition of HU blunted the CD4+ cell response, did not appear to enhance antiviral activity, and resulted in more treatment-limiting adverse events.