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Subcutaneous injection pain with C.E.R.A., a continuous erythropoietin receptor activator, compared with darbepoetin alfa

2007 LIBRAPHARM LTD - Current Medical Research 2007; 23(12)

Anne Pannier, Paul Jordan, Frank C. Dougherty, Fabrice Bour and Bruno Reigner

Objective:
This study assessed injection site pain following subcutaneous (SC) administration with a continuous erythropoietin receptor activator
(C.E.R.A.), compared with darbepoetin alfa in healthy adults. Methods: In a randomized, placebocontrolled, single-centre, single-blind, threeway
crossover study, subjects received one of six treatment sequences (ABC/ACB/BAC/BCA/CBA/CAB) involving SC injection of (A) C.E.R.A.
50 μg, (B) darbepoetin alfa 50 μg, or (C) placebo on days 1, 29, and 57. An initial pilot phase (n = 12) was used to determine the sample size
for the confirmatory phase (n = 72), and data were combined for the final analysis (n = 84).

Main outcome measures:
The primary endpoint was pain on the 100 mm visual analog scale (VAS) immediately after dosing. Secondary endpoints included VAS at 1 hour
after dosing and pain on the six-point verbal rating scale (VRS) immediately and at 1 hour after dosing.

Results:
C.E.R.A. was associated with significantly less pain immediately after SC injection compared with darbepoetin alfa: least squares mean VAS 21.5
(95% confidence interval [CI]: 17.5, 25.5) versus 33.4 (95% CI: 28.4, 38.4) ( p < 0.0001). Incidence of pain on the VRS was lower with C.E.R.A.
compared with darbepoetin alfa immediately after dosing ( p < 0.0001). One hour after administration, most subjects had no VRS pain. A study
limitation is the small sample size and the findings need to be confirmed in a large trial of chronic kidney disease patients.

Conclusions:
SC injection with C.E.R.A. is significantly less painful than SC darbepoetin alfa in healthy adults. Treatment of anemia in chronic kidney disease
with SC injection of C.E.R.A. may provide a lower pain burden compared with darbepoetin alfa.