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

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Abstract
Intravenous immunoglobulin (IVIG) is a potential therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). To investigate the efficacy and safety of the IVIG IgPro10 (Privigen) for treatment of CIDP, results from Privigen Impact on Mobility and Autonomy (PRIMA), a prospective, open-label, single-arm study of IVIG in immunoglobulin (Ig)-naive or IVIG pre-treated subjects (NCT01184846, n = 28) and Polyneuropathy And Treatment with Hizentra (PATH), a double-blind, randomized study including an open-label, single-arm IVIG phase in IVIG pre-treated subjects (NCT01545076, IVIG restabilization phase n = 207) were analyzed separately and together (n = 235). Efficacy assessments included change in adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score. Adverse drug reactions (ADRs) and ADRs/infusion were recorded. Adjusted INCAT response rate was 60.7% in all PRIMA subjects at Week 25 (76.9% in IVIG pre-treated subjects) and 72.9% in PATH. In the pooled cohort (n = 235), INCAT response rate was 71.5%; median time to INCAT improvement was 4.3 weeks. No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21). In the pooled cohort, median change from baseline to last observation was -1.0 (interquartile range -2.0; 0.0) point for INCAT score; +8.0 (0.0; 20.0) kPa for maximum grip strength; +3.0 (1.0; 7.0) points for MRC sum score. In the pooled cohort, 271 ADRs were reported in 105 subjects (44.7%), a rate of 0.144 ADRs per infusion. This analysis confirms the efficacy and safety of IgPro10, a recently FDA-approved IVIG for CIDP, in a population of mainly pre-treated subjects with CIDP [Correction added on 14 March 2019 after first online publication: the INCAT response rate has been corrected.].
Keywords
CIDP, efficacy, IVIG, PATH, PRIMA, INFLAMMATORY DEMYELINATING POLYNEUROPATHY, INTRAVENOUS IMMUNOGLOBULIN, MAINTENANCE TREATMENT, OPEN-LABEL, PHASE-III, POLYRADICULONEUROPATHY, PREVALENCE

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MLA
Merkies, Ingemar SJ et al. “Efficacy and Safety of IVIG in CIDP : Combined Data of the PRIMA and PATH Studies.” JOURNAL OF THE PERIPHERAL NERVOUS SYSTEM 24.1 (2019): 48–55. Print.
APA
Merkies, I. S., van Schaik, I. N., Léger, J.-M., Bril, V., van Geloven, N., Hartung, H.-P., Lewis, R. A., et al. (2019). Efficacy and safety of IVIG in CIDP : combined data of the PRIMA and PATH studies. JOURNAL OF THE PERIPHERAL NERVOUS SYSTEM, 24(1), 48–55.
Chicago author-date
Merkies, Ingemar SJ, Ivo N van Schaik, Jean-Marc Léger, Vera Bril, Nan van Geloven, Hans-Peter Hartung, Richard A Lewis, et al. 2019. “Efficacy and Safety of IVIG in CIDP : Combined Data of the PRIMA and PATH Studies.” Journal of the Peripheral Nervous System 24 (1): 48–55.
Chicago author-date (all authors)
Merkies, Ingemar SJ, Ivo N van Schaik, Jean-Marc Léger, Vera Bril, Nan van Geloven, Hans-Peter Hartung, Richard A Lewis, Gen Sobue, John-Philip Lawo, Billie L Durn, David R Cornblath, Jan De Bleecker, Claudia Sommer, Wim Robberecht, Mika Saarela, Jerzy Kamienowski, Zbigniew Stelmasiak, Björn Tackenberg, and Orell Mielke. 2019. “Efficacy and Safety of IVIG in CIDP : Combined Data of the PRIMA and PATH Studies.” Journal of the Peripheral Nervous System 24 (1): 48–55.
Vancouver
1.
Merkies IS, van Schaik IN, Léger J-M, Bril V, van Geloven N, Hartung H-P, et al. Efficacy and safety of IVIG in CIDP : combined data of the PRIMA and PATH studies. JOURNAL OF THE PERIPHERAL NERVOUS SYSTEM. 2019;24(1):48–55.
IEEE
[1]
I. S. Merkies et al., “Efficacy and safety of IVIG in CIDP : combined data of the PRIMA and PATH studies,” JOURNAL OF THE PERIPHERAL NERVOUS SYSTEM, vol. 24, no. 1, pp. 48–55, 2019.
@article{8618363,
  abstract     = {Intravenous immunoglobulin (IVIG) is a potential therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). To investigate the efficacy and safety of the IVIG IgPro10 (Privigen) for treatment of CIDP, results from Privigen Impact on Mobility and Autonomy (PRIMA), a prospective, open-label, single-arm study of IVIG in immunoglobulin (Ig)-naive or IVIG pre-treated subjects (NCT01184846, n = 28) and Polyneuropathy And Treatment with Hizentra (PATH), a double-blind, randomized study including an open-label, single-arm IVIG phase in IVIG pre-treated subjects (NCT01545076, IVIG restabilization phase n = 207) were analyzed separately and together (n = 235). Efficacy assessments included change in adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score. Adverse drug reactions (ADRs) and ADRs/infusion were recorded. Adjusted INCAT response rate was 60.7% in all PRIMA subjects at Week 25 (76.9% in IVIG pre-treated subjects) and 72.9% in PATH. In the pooled cohort (n = 235), INCAT response rate was 71.5%; median time to INCAT improvement was 4.3 weeks. No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21). In the pooled cohort, median change from baseline to last observation was -1.0 (interquartile range -2.0; 0.0) point for INCAT score; +8.0 (0.0; 20.0) kPa for maximum grip strength; +3.0 (1.0; 7.0) points for MRC sum score. In the pooled cohort, 271 ADRs were reported in 105 subjects (44.7%), a rate of 0.144 ADRs per infusion. This analysis confirms the efficacy and safety of IgPro10, a recently FDA-approved IVIG for CIDP, in a population of mainly pre-treated subjects with CIDP [Correction added on 14 March 2019 after first online publication: the INCAT response rate has been corrected.].},
  author       = {Merkies, Ingemar SJ and van Schaik, Ivo N and Léger, Jean-Marc and Bril, Vera and van Geloven, Nan and Hartung, Hans-Peter and Lewis, Richard A and Sobue, Gen and Lawo, John-Philip and Durn, Billie L and Cornblath, David R and De Bleecker, Jan and Sommer, Claudia and Robberecht, Wim and Saarela, Mika and Kamienowski, Jerzy and Stelmasiak, Zbigniew and Tackenberg, Björn and Mielke, Orell},
  issn         = {1085-9489},
  journal      = {JOURNAL OF THE PERIPHERAL NERVOUS SYSTEM},
  keywords     = {CIDP,efficacy,IVIG,PATH,PRIMA,INFLAMMATORY DEMYELINATING POLYNEUROPATHY,INTRAVENOUS IMMUNOGLOBULIN,MAINTENANCE TREATMENT,OPEN-LABEL,PHASE-III,POLYRADICULONEUROPATHY,PREVALENCE},
  language     = {eng},
  number       = {1},
  pages        = {48--55},
  title        = {Efficacy and safety of IVIG in CIDP : combined data of the PRIMA and PATH studies},
  url          = {http://dx.doi.org/10.1111/jns.12302},
  volume       = {24},
  year         = {2019},
}

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