Local pain during REBIF injection is not due to acidic pH
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《神经病学神经外科学杂志》
Clinical Research Unit for Multiple Sclerosis and Neuroimmunology, Department of Neurology and Department of Dermatology, Julius-Maximilians-University, Würzburg, Germany
Correspondence to:
Dr M Buttmann;
m.buttmann@mail.uni-wuerzburg.de
Keywords: multiple sclerosis; interferon beta; adverse effects
In our clinical experience, local pain at the injection site is a common adverse event for persons with MS receiving subcutaneous REBIF (interferon-?1a) injections. Most of our patients experiencing this describe a moderate burning or stabbing pain during injection, that may persist for a few minutes. These reactions vary among individuals and also for the same individual on different occasions. The acidic pH of REBIF, which is necessary to ensure stability of the IFN-?1a solution, is considered a possible cause of pain. We provide data suggesting that the pH of 3.8 cannot be the sole reason for the local pain during REBIF injection.
Seven unselected subjects with MS, all having
All the recipients were asked before injection to describe their sensations during and after the procedure, to which they were all blinded. The unblinded clinical investigator made no comments until the skin biopsies had been completed the next day, nor were the participants asked any additional questions. They
All seven subjects reported a moderate burning pain at the REBIF site during injection. The pain was described as similar to what they had previously experienced in all cases. At the site of placebo injection, only a slight feeling of pressure during the injection was reported and almost no pain. Without specifically being asked, all seven individuals correctly identified the REBIF injection site. Our findings provide evidence that the pain of REBIF injection cannot be solely due to the acidic pH of REBIF, because no pain was perceived with placebo injections at a similar pH. Rather, the pain may be due to IFN-? in combination with the acidic pH, to other aspects of the IFN-? formulation, or to the needle tip used for injection. Although pain can be overcome to some extent by cooling of injection site before and after the procedure, the true cause of the pain remains to be elucidated.
ACKNOWLEDGEMENTS
We thank Professor K V Toyka for critical reading of the manuscript.
References
PRISMS study group. Randomised double-blind placebo-controlled study of interferon ?-1a in relapsing/remitting multiple sclerosis. Lancet 1998;352:1498–504.
SPECTRIMS study group. Randomized controlled trial of interferon-beta-1a in secondary progressive MS: clinical results. Neurology 2001;56:1496–504.
Comi G , Filippi M, Barkhof F, et al. Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet 1998;357:156–82.(M Buttmann, M Goebeler an)
Correspondence to:
Dr M Buttmann;
m.buttmann@mail.uni-wuerzburg.de
Keywords: multiple sclerosis; interferon beta; adverse effects
In our clinical experience, local pain at the injection site is a common adverse event for persons with MS receiving subcutaneous REBIF (interferon-?1a) injections. Most of our patients experiencing this describe a moderate burning or stabbing pain during injection, that may persist for a few minutes. These reactions vary among individuals and also for the same individual on different occasions. The acidic pH of REBIF, which is necessary to ensure stability of the IFN-?1a solution, is considered a possible cause of pain. We provide data suggesting that the pH of 3.8 cannot be the sole reason for the local pain during REBIF injection.
Seven unselected subjects with MS, all having
All the recipients were asked before injection to describe their sensations during and after the procedure, to which they were all blinded. The unblinded clinical investigator made no comments until the skin biopsies had been completed the next day, nor were the participants asked any additional questions. They
All seven subjects reported a moderate burning pain at the REBIF site during injection. The pain was described as similar to what they had previously experienced in all cases. At the site of placebo injection, only a slight feeling of pressure during the injection was reported and almost no pain. Without specifically being asked, all seven individuals correctly identified the REBIF injection site. Our findings provide evidence that the pain of REBIF injection cannot be solely due to the acidic pH of REBIF, because no pain was perceived with placebo injections at a similar pH. Rather, the pain may be due to IFN-? in combination with the acidic pH, to other aspects of the IFN-? formulation, or to the needle tip used for injection. Although pain can be overcome to some extent by cooling of injection site before and after the procedure, the true cause of the pain remains to be elucidated.
ACKNOWLEDGEMENTS
We thank Professor K V Toyka for critical reading of the manuscript.
References
PRISMS study group. Randomised double-blind placebo-controlled study of interferon ?-1a in relapsing/remitting multiple sclerosis. Lancet 1998;352:1498–504.
SPECTRIMS study group. Randomized controlled trial of interferon-beta-1a in secondary progressive MS: clinical results. Neurology 2001;56:1496–504.
Comi G , Filippi M, Barkhof F, et al. Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet 1998;357:156–82.(M Buttmann, M Goebeler an)