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Drug Evaluations

The erythropoietin analog ARA 290 for treatment of sarcoidosis-induced chronic neuropathic pain

, , , , , , & show all
Pages 77-87 | Published online: 17 Dec 2012

Figures & data

Box 1. Drug summary.

Figure 1. Chemical structure of ARA 290.

Figure 1. Chemical structure of ARA 290.

Figure 2. Pharmacokinetic data obtained in healthy volunteers. A. Male subjects receiving subcutaneous ARA 290 at doses 2 mg (n = 10), 4 mg (n = 5) and 6 mg (n = 5). B. Male subjects receiving an intravenous dose of 2 mg (n = 10). Values are mean ± SEM.

Figure 2. Pharmacokinetic data obtained in healthy volunteers. A. Male subjects receiving subcutaneous ARA 290 at doses 2 mg (n = 10), 4 mg (n = 5) and 6 mg (n = 5). B. Male subjects receiving an intravenous dose of 2 mg (n = 10). Values are mean ± SEM.

Figure 3. Effect of treatment with ARA 290 treatment for 15 weeks (weeks 1 and 2: 0.03 mg/kg at a 2-day interval, weeks 3–15: 0.03 mg/kg once weekly) on allodynia in a spared nerve injury rat model. Allodynia was measured using von Frey filaments; the force (in grams) causing a withdrawal response of the affected paw is given on the y-axis. Open squares are sham-operated animals, open triangles vehicle-treated animals, closed circles ARA 290-treated animals (n = 8/group). The closed triangles denote the ARA 290 treatment days. Values are mean ± SEM.

Figure 3. Effect of treatment with ARA 290 treatment for 15 weeks (weeks 1 and 2: 0.03 mg/kg at a 2-day interval, weeks 3–15: 0.03 mg/kg once weekly) on allodynia in a spared nerve injury rat model. Allodynia was measured using von Frey filaments; the force (in grams) causing a withdrawal response of the affected paw is given on the y-axis. Open squares are sham-operated animals, open triangles vehicle-treated animals, closed circles ARA 290-treated animals (n = 8/group). The closed triangles denote the ARA 290 treatment days. Values are mean ± SEM.

Table 1. Study design of trial #1, An open-label study on the effect of a 1-week treatment with intravenous ARA 290 on pain scores in chronic neuropathic pain patients.

Table 2. Patient characteristics of trial #1 (see ).

Figure 4. Effect of ARA 290 treatment on neuropathic pain in 10 sarcoidosis patients (A) and 10 patients with diabetes mellitus (B). Responders are defined as patients with a reduction in pain score ≥ 2 points within the initial 10 days following the start of treatment. Star: p < 0.05 vs. baseline pain score (analysis on all patients). The closed triangles denote the ARA 290 treatment days. Values are mean ± SEM. The broken grey lines are the 30% and 50% response lines. For study design see and for patient characteristics see .

Figure 4. Effect of ARA 290 treatment on neuropathic pain in 10 sarcoidosis patients (A) and 10 patients with diabetes mellitus (B). Responders are defined as patients with a reduction in pain score ≥ 2 points within the initial 10 days following the start of treatment. Star: p < 0.05 vs. baseline pain score (analysis on all patients). The closed triangles denote the ARA 290 treatment days. Values are mean ± SEM. The broken grey lines are the 30% and 50% response lines. For study design see Table 1 and for patient characteristics see Table 2.

Figure 5. Effect of a 3-week ARA 290 treatment in one sarcoidosis patient with severe neuropathic pain. The closed triangles denote the ARA 290 treatment days. The broken grey lines are the 30% and 50% response lines.

Figure 5. Effect of a 3-week ARA 290 treatment in one sarcoidosis patient with severe neuropathic pain. The closed triangles denote the ARA 290 treatment days. The broken grey lines are the 30% and 50% response lines.

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