Patient-Reported Outcomes from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar® Gel) for Persistently Active Systemic Lupus Erythematosus

Askanase, Anca; Wan, George J.; Panaccio, Mary P; Zhao, Enxu; Zhu, Jessica; Bilyk, Roman; Furie, Richard

doi:10.1007/s40744-021-00294-z

Cited by 9 publications

(13 citation statements)

References 26 publications

(46 reference statements)

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“…PRO tools used in the studies summarized in this report include the functional assessment of chronic illness therapy-fatigue (FACIT-F) [ 11 , 12 ]; the lupus quality of life (LupusQOL) instrument, which includes pain-specific and fatigue-specific domains [ 25 ]; the fatigue assessment scale (FAS) [ 15 ]; patient assessment of pain by VAS (VAS pain) [ 22 , 26 ]; and for uveitis and keratitis, the ocular discomfort score (ODS) [ 16 ]; four-symptom questionnaire (assessing dryness, grittiness, burning, stinging) [ 16 ]; and eye-specific VAS measures (assessing eye dryness, burning/stinging, itching, foreign body sensation, eye discomfort, photophobia, pain) [ 16 ]. Burning and stinging may be considered indicators of pain in patients with keratitis.…”

Section: Resultsmentioning

confidence: 99%

Pain and Fatigue Improvements in Patients Treated with Repository Corticotropin Injection Across Five Indications: A Narrative Review

et al. 2022

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Repository corticotropin injection (RCI; Acthar ® Gel) is approved by the US Food and Drug Administration (FDA) for use in 19 indications, including for the treatment of selected patients with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), symptomatic sarcoidosis, uveitis, and keratitis. Despite treatment with disease-modifying antirheumatic drugs, many patients with RA, SLE, and other chronic inflammatory rheumatic diseases continue to be affected by severe pain and fatigue, indicating a need for other therapies. To examine the clinical data regarding the impact of RCI treatment on pain and fatigue in selected populations, this review included English-language peer-reviewed publications of clinical trials of any size and cohort studies with more than 10 patients that included pain and/or fatigue based on patient-reported outcomes (PROs) and/or physician-assessed measures in adults following treatment with RCI for RA, SLE, symptomatic sarcoidosis, uveitis, or keratitis. Literature searches identified eight studies that met these criteria. Four studies (reported in five publications) were in patients with RA or SLE, two in patients with sarcoidosis, one in patients with uveitis, and one in patients with noninfectious keratitis. Across the different types of studies assessed (clinical trials, chart reviews, real-world evidence), the results were consistent with respect to the impact of RCI treatment on improving pain and fatigue. As summarized in this review, data from patient- and physician-reported outcome measures in eight studies demonstrate that, in addition to improving more traditional efficacy measures, RCI may also improve pain and fatigue in patients with RA, SLE, symptomatic sarcoidosis, uveitis, and noninfectious keratitis.

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Section: Resultsmentioning

confidence: 99%

Pain and Fatigue Improvements in Patients Treated with Repository Corticotropin Injection Across Five Indications: A Narrative Review

et al. 2022

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“…Two Phase III trials assessing the efficacy and safety of Epratuzumab in SLE patients with moderate-to-severe disease found no significant differences in various disease activity scores or LupusQoL scores between the placebo and the treatment groups, at 48 weeks [35]. Moreover, a Phase 4 multi-centre RCT examining the efficacy and safety of Acthar Gel in persistently active SLE patients demonstrated significant and clinically meaningful improvements in LupusQoL scores for the pain, planning, and fatigue domains in those who had higher disease activity levels [36]. Lastly, the remaining two clinical trials found that upper limb exercises [37] and a digital therapeutic plus telehealth coaching intervention [38] led to significant and clinically meaningful improvements in HRQoL as measured by LupusQoL scores.…”

Section: Lupusqolmentioning

confidence: 97%

Patient-Reported Outcomes for Quality of Life in SLE: Essential in Clinical Trials and Ready for Routine Care

Nguyen

Huang

O’Neill

2021

JCM

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Patient-reported outcome (PRO) instruments are widely used to assess quality of life in Systemic Lupus Erythematosus (SLE) research, and there is growing evidence for their use in clinical care. In this review, we evaluate the current evidence for their use in assessing quality of life in SLE in both research and clinical settings and examine the different characteristics of the commonly used PRO tools. There are now several well-validated generic and SLE-specific tools that have demonstrated utility in clinical trials and several tools that complement activity and damage measures in the clinical setting. PRO tools may help overcome physician–patient discordance in SLE and are valuable in the assessment of fibromyalgia and type 2 symptoms such as widespread pain and fatigue. Future work will identify optimal PRO tools for different settings but, despite current limitations, they are ready to be incorporated into patient care.

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“…Patient-reported outcomes from subjects in the aforementioned clinical trial [ 29 ] were analyzed using the Lupus QoL questionnaire and the Work Productivity and Activity Impairment (WPAI)-Lupus questionnaire [ 42 ]. Post hoc analysis uncovered significant improvements with RCI treatment in quality of life and work productivity, particularly in patients with high disease activity.…”

Section: Rci For the Treatment Of Slementioning

confidence: 99%

“…Post hoc analysis uncovered significant improvements with RCI treatment in quality of life and work productivity, particularly in patients with high disease activity. Compared with placebo, subjects treated with RCI reported significant improvements in the Lupus QoL pain , planning , and fatigue domains and in the domains of WPAI-Lupus percentage impairment while working and percentage work time missed [ 42 ].…”

Section: Rci For the Treatment Of Slementioning

confidence: 99%

A Narrative Review of Repository Corticotropin Injection for the Treatment of Systemic Lupus Erythematosus

Askanase

Furie

2022

Adv Ther

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Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder that affects multiple organ systems. The most prevalent manifestations include constitutional symptoms, arthritis, and rash. An SLE flare is defined as a measurable increase in disease activity that may prompt a change in treatment. According to the European Alliance of Associations for Rheumatology guidance, SLE treatments should be aimed at reducing disease activity and flares, as well as preventing organ damage. Standard-of-care treatment of SLE includes glucocorticoids, but their long-term use is associated with damage accrual. Repository corticotropin injection (RCI; Acthar ® Gel) is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides that has anti-inflammatory and immunomodulatory effects beyond its steroidogenic effect, and has been US Food and Drug Administration–approved for the treatment of SLE flares and as a maintenance therapy. This review summarizes data from three clinical trials that evaluated the efficacy and safety of RCI in the treatment of patients with moderate–severe refractory SLE. These clinical trials confirmed that RCI improved global disease activity scores and some SLE clinical manifestations. Analysis of pooled data from these trials showed that RCI treatment significantly improved the British Isles Lupus Assessment Group 2004 (BILAG-2004) index scores after 8 weeks of treatment, and tender and swollen joint counts after 4 weeks. These clinical trials demonstrated an acceptable safety profile with few serious adverse events reported. The distinct mechanisms of action from standard-of-care therapies and the favorable safety and good efficacy profiles support the use of RCI as therapy for patients with refractory SLE.

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Patient-Reported Outcomes from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar® Gel) for Persistently Active Systemic Lupus Erythematosus

Cited by 9 publications

References 26 publications

Pain and Fatigue Improvements in Patients Treated with Repository Corticotropin Injection Across Five Indications: A Narrative Review

Pain and Fatigue Improvements in Patients Treated with Repository Corticotropin Injection Across Five Indications: A Narrative Review

Patient-Reported Outcomes for Quality of Life in SLE: Essential in Clinical Trials and Ready for Routine Care

A Narrative Review of Repository Corticotropin Injection for the Treatment of Systemic Lupus Erythematosus

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