Intravenous immunoglobulin is effective in patients with diabetes and with chronic inflammatory demyelinating polyneuropathy: long term follow-up

S Jann; M A Bramerio; D Facchetti; R Sterzi

doi:10.1136/jnnp.2008.149013

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Intravenous immunoglobulin is effective in patients with diabetes and with chronic inflammatory demyelinating polyneuropathy: long term follow-up

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Re: Are intravenous immunoglobulines truly beneficial in diabetic patients with CIDP?
Stefano Jann
Published on: 13 April 2016
Are intravenous immunoglobulines truly beneficial in diabetic patients with CIDP?
Josef Finsterer
Published on: 13 April 2016

Published on: 13 April 2016
Re: Are intravenous immunoglobulines truly beneficial in diabetic patients with CIDP?
- Stefano Jann
Dear Editor,
we are indebted with Dr. Josef Finsterer and Dr. Marlies Frank because they give us the chance to explain some points of our paper. We will reply to their concerns as requested.
We followed the most restrictive diagnostic criteria of the AAN because we needed to extremely select our patients. Our neurophysiological criteria are slightly more restrictive than the AAN criteria and we have r...
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Dear Editor,
we are indebted with Dr. Josef Finsterer and Dr. Marlies Frank because they give us the chance to explain some points of our paper. We will reply to their concerns as requested.
We followed the most restrictive diagnostic criteria of the AAN because we needed to extremely select our patients. Our neurophysiological criteria are slightly more restrictive than the AAN criteria and we have reported it in the methods. We thought it was valuable.
In the Results section we have pointed out that our patients had no sensory disturbances at first examination "on clinical grounds". It does not exclude a neurophysiological or pathological involvement of the sensory nerves as documented.
We have admitted that NIS is much more sensitive to changes in motor than in sensory disturbances, but nevertheless improvement in motor function is significant. SAP reduction is prevalent in diabetic patients with sensory symptoms. We speculated that sensory disturbances are related to superimposed diabetic sensory polyneuropathy and not to worsening of the CIDP because of the concomitant improvement of motor function. It is well known that even in patients with long term excellent glycaemic control the incidence of diabetic neuropathy remains elevated (Martini CL et al, Diabetes Care 2006, 29, 340-344).
Obviously we do not know why these 2 patients did not respond to IVIg therapy. Our established criteria to classify patients as treatment responders or non-responders are clearly pointed out in the methods section. We evaluated the response to the first course of IVIg. Non- responders remained unchanged or worsened. This choice could be inappropriate but we established it before the beginning of the study. Patients classified as treatment responders were treated again in case of relapse. Relapse was defined as worsening after improvement with an increase of 4 points or more in the NIS score (see methods - treatment and outcome).
No patient had renal insufficiency at baseline (see results: "only one patient complained of other complication of diabetes-retinopathy") and no patient developed it during IVIg therapy.
Neurophysiological studies of the ulnar nerve were carried out. There is an overlap between ulnar and median nerve data.
Last, we have no clear explanation for our male preponderance.
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Conflict of Interest:
None declared.
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Published on: 13 April 2016
Are intravenous immunoglobulines truly beneficial in diabetic patients with CIDP?
- Josef Finsterer
- Other Contributors:
  Marlies Frank
Dear Editor,
With interest we read the article by Jann et al. on 16 patients with diabetic mellitus (DM) who also developed chronic inflammatory demyelinating polyneuropathy (CIDP) [1]. The study raises concerns.
Though it is stated that CIDP was diagnosed according to the criteria of the American Academy of Neurology (AAN) [2,3], the authors define partial conduction block and abnormal temporal dispers...
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Dear Editor,
With interest we read the article by Jann et al. on 16 patients with diabetic mellitus (DM) who also developed chronic inflammatory demyelinating polyneuropathy (CIDP) [1]. The study raises concerns.
Though it is stated that CIDP was diagnosed according to the criteria of the American Academy of Neurology (AAN) [2,3], the authors define partial conduction block and abnormal temporal dispersion at variance from what is recommended by the AAN [2]. According to the AAN criteria partial conduction block (CB) is defined as >20% drop in negative peak area or peak-to-peak amplitude plus <15% change in duration of the negative peak between proximal and distal sites (partial CB) or >15% change in duration between proximal and distal sites (possible CB/temporal dispersion) [2].
How to explain that none of the 16 patients with CIDP had sensory disturbances at the first examination but all had reduced sensory nerve conduction velocity of the median and sural nerves and severe loss of myelinated fibres and macrophage infiltration and nine T-cell infiltration on sural nerve biopsy?
Assessment of the clinical reaction to intravenous immunoglobulines (IVIG) by the neuropathy impairment score (NIS) is misleading, since the NIS predominantly scores motor functions [4], as admitted. Since eight of the 16 developed sensory disturbances, including paresthesias, during follow-up and since the summed sensory action potential (SAP) amplitude of the sural and median nerve decreased during the 40m follow-up, the overall results may be false positive.
Was the reduction of the SAP-amplitude particularly found in the eight patients who developed sensory disturbances under IVIG?
Was the development of sensory disturbances attributed to worsening diabetic polyneuropathy or to non-responding CIDP? How can the development of sensory abnormalities be attributed to superimposed diabetic polyneuropathy if the glycaemic control was excellent?
Which was the reason why two of the 16 did not respond to IVIG at all? How often were IVIG in these two patients administered before they were classified as non-responders? Which were the criteria according to which they were classified as non-responders?
Except for two patients all others received IVIG repeadetly. Which were the criteria to repeat the treatment?
How many patients had renal insufficiency before IVIG and in how many did renal insufficiency worsen after IVIG?
In the method section also the ulnar nerve is mentioned to have been investigated. Which is the reason why no results of this nerve are presented?
How to explain the marked male preponderance among CIDP patients (male/female: 13/3)?
As long as these concerns are not fully addressed there remain doubts about the study results in particular the effectiveness of IVIG in diabetic patients who also develop CIDP.
References
1. Jann S, Bramerio MA, Facchetti D, Sterzi R.
Intravenous immunoglobulin is effective in patients with diabetes and with chronic inflammatory demyelinating polyneuropathy: long term follow-up. J Neurol Neurosurg Psychiatry 2009;80:70-3.
2. Cornblath DR, Feasby TE, Hahn AF, et al.
Research criteria for diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP). Neurology 1991;41:61718.
3. Sander HW, Latov N.
Research criteria for defining patients with CIDP. Neurology 2003;60(suppl 3):S8-15.
4. Dyck PJ, Davies JL, Litchy WJ, O'Brien PC.
Longitudinal assessment of diabetic polyneuropathy using a composite score in the Rochester Diabetic Neuropathy Study cohort. Neurology 1997;49:229-39.
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Conflict of Interest:
None declared.
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