ARA 290 Improves Symptoms in Patients with Sarcoidosis-Associated Small Nerve Fiber Loss and Increases Corneal Nerve Fiber Density

Table 1 Baseline patient characteristics.

	ARA 290	Placebo
n	21	17
Years since diagnosis of sarcoidosis (mean ± SEM)	7,1 ± 1,2	9.9 ± 2.4
Concomitant medical treatment [n (%)]
NSAIDS	5 (23.8)	8 (47.1)
Neurological/psychological drugs	5 (23.8)	6 (35.3)
Oral corticosteroids	6 (28.6)	7 (41.2)
Opioids	6 (28.6)	2 (11.8)
Systemic immune suppressants (methotrexate or azathioprine)	7 (33.3)	3 (17.7)
Prior TNFα antagonist treatment (n = yes)	2 (9.5)	0
SFNSL
Total score	43.9 ± 2.9	42.8 ± 3.2
Autonomic component	20.6 ± 2.0	20.8 ± 1.5
Pain component	23.3 ± 1.2	22.9 ± 1.2
BPI
Mean score (pain now; range 0–10)	5.0 ± 0.4	5.3 ± 0.5
Pain interference (maximum 70)	32.1 ± 1.9	36.5 ± 2.9
6-Min walk
Test, actual (m)	468 ± 18	479 ± 26
Test, predicted (m)^a	700 ± 12	683 ± 15
Nerve fiber density
Corneal nerve fiber area (µm²)	1,576 ± 94	1,304 ± 104
Normal corneal nerve fiber area^b	3,134 ± 119
Ankle IENFD (n/mm)	5.3 ± 0.5	4.6 ± 0.4
Normal sex- and age-adjusted ankle IENFD^c	9.9 ± 0.3	9.8 ± 0.3
Proximal thigh IENFD (n/mm)	10.8 ± 0.7	11.1 ± 0.9
Normal proximal thigh IENFD^d	21.1 ± 0.2	21.0 ± 0.1
Laboratory markers
High sensitivity C-reactive protein (mg/L)	1.5 ± 0.2	2.9 ± 1.1
Angiotensin-converting enzyme^e	47.4 ± 6.1	53.6 ± 8.0
Number with elevated angiotensin-converting enzyme n(%)	5 (23.8)	6 (35.3)

^aPredicted 6MWT was calculated by using the formula of Troosters et al. (32).
^bData calculated from Brines et al.(30).
^cNormal sex- and age-adjusted ankle IENFD is from Lauria et al.(26).
^dNormal proximal thigh IENFD is from Umapathi et al. (27).
^eNormal: 23–67 nmol/min/mL.

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