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Introduction/aims: Treatment response and its timing are variable in chronic inflammatory demyelinating polyneuropathy (CIDP). In this study we assessed the variability using multiple outcome measures., Methods: We performed a post hoc analysis of the PRISM trial, a 24-week prospective, multicenter, single-arm, open-label, phase III study of a 10% intravenous immunoglobulin preparation for CIDP. We ascertained timing of response with primary/secondary outcome measures., Results: At 6 weeks after treatment initiation, 13 of 40 subjects (32.5%) were defined as responders on the primary outcome measure, the adjusted Inflammatory Neuropathy Cause And Treatment (INCAT) scale. This increased to 20 of 41 (48.8%) at 12 weeks and to 32 of 42 (76.2%) at 24 weeks. Use of minimal important difference (MID)-determined amelioration of the inflammatory Rasch-built Overall Disability Scale (I-RODS), or of the Medical Research Council sum score (MRCSS), or of dominant hand-grip strength, in addition to the adjusted INCAT, indicated a sensitivity of 41.7% in identifying adjusted INCAT nonresponders at week 12 who subsequently responded at week 24. Specificity was 60% vs INCAT nonresponders at week 24. Consideration of amelioration of any amplitude on any secondary outcome measure indicated a 75% sensitivity, but only 30% specificity vs adjusted INCAT nonresponders at week 24., Discussion: Immunoglobulin treatment continuation may be justified for up to 24 weeks in CIDP. Additional outcome measures may help in the early treatment stages to predict delayed response on the adjusted INCAT. However, their use is limited by high false-positive rates. More robust, reliable, and relevant outcome measures are needed to detect early improvement in immunoglobulin-treated CIDP., (© 2022 The Authors. Muscle & Nerve published by Wiley Periodicals LLC.)

This prospective, multicenter, single-arm, open-label phase 3 study aimed to evaluate the efficacy and safety of IqYmune in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Patients received one induction dose of 2 g/kg and then seven maintenance doses of 1 g/kg at 3-week intervals. The primary endpoint was the responder rate at the end of study (EOS), defined as an improvement of ≥1 point on the adjusted inflammatory neuropathy cause and treatment (INCAT) disability scale. The responder rate was compared with the responder rate of a historical placebo group (33.3%). Secondary endpoints included changes from baseline to EOS of adjusted INCAT disability score, grip strength, Medical Research Council (MRC) sum score, Rasch-modified MRC sum score, Rasch-built overall disability scale score and the clinical global impression. Forty-two patients, including 23 Ig-naïve and 19 Ig-pre-treated, were included in the efficacy set. The overall response rate at EOS was 76.2% (95% confidence interval [60.5%-87.9%]). The superiority of IqYmune compared to the historical placebo control was demonstrated (P < .0001). The responder rate was numerically higher in Ig-pre-treated than in Ig-naïve patients but confidence intervals were overlapping (84.2% [60.4%-96.6%] vs 69.6% [47.1%-86.8%]). All secondary endpoints confirmed this conclusion. The median time to response was 15 weeks [8.9-19.1 weeks]. A total of 156 adverse events including five serious were considered related to IqYmune, 87.2% were mild. Neither hemolysis nor signs of renal or hepatic impairment were observed. These results demonstrate that IqYmune is an effective and well-tolerated treatment in patients with CIDP., (© 2020 The Authors. Journal of the Peripheral Nervous System published by Wiley Periodicals LLC on behalf of Peripheral Nerve Society.)

Aim: Chronic venous disease affects large numbers of men but there are fewer references to them than to women in the literature. The aim of our study was to determine the time lapse between the first symptom(s) and/or clinical signs of venous disease in the male and the first consultation with an angiologist to define the status of the veins within this population, and to demonstrate any possible links between the characteristics of the disorder in accordance with the CEAP international classification., Methods: The design was a cross-sectional descriptive survey. Each physician had to include the first 3 patients examined for the first time. Each male patient had to present at least 1 sign and 1 symptom of chronic venous disease. After randomization, 192 physicians included 561 patients: 494 have been analyzed., Results: The examined patients had a mean age of 49.3+/-13.7 years, mean height of 1.76+/-0.07 m, mean weight of 78.2+/-11.2 kg and a BMI of 25.3+/-3.3. The disorder had been developing for a mean 76.8+/-90.3 months prior to the specialist consultation. The longer the time span between the onset of the condition and the first consultation with a specialist, the more advanced was the condition as was also true with the increasing age of the patients. The following associations were observed: the incidence of trophic disorders increased with age (odds-ratio 1.47). The severity of the disease increased the greater the extent of obesity (odds-ratio 3.5)., Conclusion: The risk of trophic disorders was higher in shop workers, craftsmen (odds-ratio 3.7) and workers (odds-ratio 2.68) than in executives, in those working in a standing position (odds-ratio 1.5), in those whose father had the condition (odds-ratio 1.9), in the event of a popliteal reflux (odds-ratio 3.2) rather than affecting a saphenous trunk (small saphenous vein odds-ratio 2.5, great saphenous vein odds-ratio 1.9). Thirty-two percent of patients with trophic disorders had already worn elastic compression prior to the specialist consultation. After this consultation, the numbers for whom this was prescribed rose to 87%.