Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies

Merkies, Ingemar S. J.; Schaik, Ivo N. van; Léger, Jean‐Marc; Bril, Vera; Geloven, Nan van; Hartung, Hans‐Peter; Lewis, Richard A.; Sobue, Gen; Lawo, John‐Philip; Durn, Billie L.; Cornblath, David R.; Bleecker, Jan De; Sommer, Claudia; Robberecht, Wim; Saarela, Mika; Kamienowski, Jerzy; Stelmasiak, Z; Tackenberg, Björn; Mielke, Orell

doi:10.1111/jns.12302

Cited by 18 publications

(12 citation statements)

References 18 publications

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“…Our percentage of patients with TAEs is at the lower end of adverse event rates, as reported in a Cochrane systematic review of IVIG TAEs, which ranged between 0.6% and 71% 11 . However, the frequency of TAEs for infusion rates in this study are similar to other cohorts 12,13 …”

Section: Discussionsupporting

confidence: 72%

Efficacy and safety of high infusion rate IVIG in CIDP

et al. 2020

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Background: We aimed to determine the safety and tolerance of higher rates of infusion of intravenous immunoglobulin (IVIG) in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Methods: Patients began infusions with 10% IVIG at the standard rate of 0.08 mL/ kg/min. If tolerated, infusion rates were incrementally increased to 0.14 mL/kg/min. We considered the frequency of infusions with adverse events (AEs) as the primary outcome. Results: Nineteen of 25 patients safely tolerated the maximum rate of 0.14 mL/kg/ min. We observed 25 treatment-related AEs (TAEs) over 13 infusions at standard or transitional rates, across seven patients. We observed no TAEs associated with the maximum infusion rate. Conclusions: We found that 10% IVIG can be safely administered at a high infusion rate (0.14 ml/kg/min) in most CIDP patients, reducing the treatment time and burden on healthcare resources.

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Section: Discussionsupporting

confidence: 72%

Efficacy and safety of high infusion rate IVIG in CIDP

et al. 2020

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“…Immunotherapies that have been shown to be effective in the treatment of CIDP include glucocorticoids, intravenous immunoglobulin (IVIG), subcutaneous immunoglobulin, and plasma exchange . Intravenous immunoglobulin is the first‐line treatment in most patients . Steroids, administered in pulsed or daily doses, are also used as first‐line treatment, but their associated adverse effects make long‐term treatment difficult .…”

Section: Introductionmentioning

confidence: 99%

Rituximab in refractory chronic inflammatory demyelinating polyneuropathy

et al. 2020

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Introduction: Chronic inflammatory demyelinating polyneuropathy (CIDP) is a disorder in which early effective treatment is important to minimize disability from axonal degeneration. It has been suggested that some patients with CIDP may benefit from rituximab therapy, but there is no definitive evidence for this. Methods: Baseline and post-rituximab-therapy neuromuscular Medical Research Council (MRC) sum scores, Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, and functional status were assessed in 11 patients with refactory CIDP.Results: The MRC sum score, INCAT disability score, and functional status improved in all patients after rituximab therapy. Discussion:Our study provides evidence of the efficacy of rituximab therapy in at least some patients with CIDP. A placebo-controlled study to assess the effectiveness of rituximab therapy in CIDP with and without nodal antibodies is required to identify disease markers that predict responsiveness. K E Y W O R D S

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“…In addition, no new safety finding or trend arised from this study confirming the known safety profile of this group of therapies. 15…”

Section: Discussionmentioning

confidence: 99%

An international multicenter efficacy and safety study of IqYmune in initial and maintenance treatment of patients with chronic inflammatory demyelinating polyradiculoneuropathy: PRISM study

Nobile‐Orazio

Pujol

Kasiborski

et al. 2020

J Peripheral Nervous Sys

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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.

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Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies

Cited by 18 publications

References 18 publications

Efficacy and safety of high infusion rate IVIG in CIDP

Efficacy and safety of high infusion rate IVIG in CIDP

Rituximab in refractory chronic inflammatory demyelinating polyneuropathy

An international multicenter efficacy and safety study of IqYmune in initial and maintenance treatment of patients with chronic inflammatory demyelinating polyradiculoneuropathy: PRISM study

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