Fiechtner JJ and Montroy T—Lupus, 2014
Acthar Gel was studied in patients with chronic SLE who were experiencing flares and required an alternative to prednisone1
STUDY OBJECTIVE
An open-label, prospective, 4-week study of 10 patients with chronic moderately to severely active SLE disease and experiencing SLE flares1
- Diagnosis of SLE with chronic disease activity defined as:
- Patients had to fulfill at least 4 of the 11 ACR classification criteria for SLE,* including a history of antinuclear antibody positivity
- SLE flare defined by ACR criteria as all of the following:
- Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAl-2K) score ≥6
- At least 1 "A" organ system score or 2 "B" organ system scores on the British Isles Lupus Assessment Group (BILAG) index
- Physician Global Assessment score ≥1 on a 0-3 VAS
- Patients received either a stable dose of prednisone (or equivalent) ≤20 mg/day for at least 4 weeks or 8 weeks of a commonly used immunosuppressive or antimalarial treatment for SLE
- Most patients self-administered Acthar Gel 80 U daily for 10 days, in addition to their existing regimen†
- There was an optional 5-day extension for partial responders or nonresponders (defined as a SLEDAl-2K >6)
- Patients were assessed weekly for 28 days and could report adverse events at any time during the study
*Patients had to meet at least 4 of the 11 ACR criteria to meet the standards of diagnosis. The 11 criteria included: discoid rash, hematologic disorder, immunologic disorder, malar rash, neurologic disorder, nonerosive arthritis, oral ulcers, photosensitivity, pleuritis or pericarditis, positive antinuclear antibody, and renal disorder.
†One patient received Acthar Gel treatment for 7 days due to an adverse event.
Study Assessments1
Primary Endpoint
- SLEDAl-2K improvement at Day 28 against baseline scores
Secondary Endpoints
- Physician Global Assessment
- Patient Global Assessment
- Erythrocyte Sedimentation Rate (ESR)
- Lupus Quality of Life (Lupus QoL) scale
- Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-Fatigue) scale
Patient Characteristics
Patients had chronic SLE and were previously treated with multiple therapies
| Mean age | Mean disease duration |
| 49 years | 7 years |
| Mean number ACR criteria | Mean SLEDAI-2K at baseline |
| 5.4 | 9.6 |
| Concomitant treatments‡ | |
| Meloxicam Methotrexate Ibuprofen Hydroxychloroquine Prednisone Folic Acid Belimumab Celecoxib Doxycycline Diclofenac Cream Tramadol Diclofenac Sodium Azulfidine Hydrocortisone |
|
| Mean age | Mean disease duration | Mean number ACR criteria | Mean SLEDAI-2K at baseline | Concomitant treatments‡ |
| 49 years | 7 years | 5.4 | 9.6 | Meloxicam Methotrexate Ibuprofen Hydroxychloroquine Prednisone Folic Acid Belimumab Celecoxib Doxycycline Diclofenac Cream Tramadol Diclofenac Sodium Azulfidine Hydrocortisone |
‡Not every patient was on the same concomitant treatments.
Study Limitations
Results are based on a prospective, single-site, open-label, non–placebo-controlled study of 10 patients and may not be fully representative of outcomes in the overall patient population. Most patients were on multiple therapies. The clinical outcomes may not be solely attributable to Acthar Gel. Acthar Gel has not been formally studied in combination with other commonly used therapies for SLE.
Acthar Gel reduced SLEDAI-2K scores at all follow-up visits when added to standard SLE regimen1
Statistically significant reductions in SLEDAI-2K scores with Acthar Gel by Day 28 (N=10)§
§SLEDAI-2K scores were calculated for each patient based on the presence or absence of organ manifestations in the previous 10 days. Responses for each organ manifestation were weighted and totaled into the final score, ranging from 0 (inactive disease) to 105.
All patients (N=10) saw statistically significant improvements in the following secondary endpoints by Day 281
- Physician Global Assessment
- Patient Global Assessment
- ESR
- Lupus QoL scale
- FACIT-Fatigue scale
Safety Findings
- No treatment-related significant adverse events or unexpected adverse reactions were observed
- One patient experienced bilateral edema in the legs/ankles
- One patient reported a sinus infection that resolved with antibiotic treatment
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Systemic Lupus Erythematosus (SLE) 
