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3. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Sabet, A., George, K., Roberts, L., Carne, R., Blum, S., Henderson, R., Van Damme, P., Demeestere, J., Larue, S., D'Amour, C., Bril, V., Breiner, A., Kunc, P., Valis, M., Sussova, J., Kalous, T., Talab, R., Bednar, M., Toomsoo, T., Rubanovits, I., Gross-Paju, K., Sorro, U., Saarela, M., Auranen, M., Pouget, J., Attarian, S., Le Masson, G., Wielanek-Bachelet, A., Desnuelle, C., Delmont, E., Clavelou, P., Aufauvre, D., Schmidt, J., Zschuentssch, J., Sommer, C., Kramer, D., Hoffmann, O., Goerlitz, C., Haas, J., Chatzopoulos, M., Yoon, R., Gold, R., Berlit, P., Jaspert-Grehl, A., Liebetanz, D., Kutschenko, A., Stangel, M., Trebst, C., Baum, P., Bergh, F., Klehmet, J., Meisel, A., Klostermann, F., Oechtering, J., Lehmann, H., Schroeter, M., Hagenacker, T., Mueller, D., Sperfeld, A., Bethke, F., Drory, V., Algom, A., Yarnitsky, D., Murinson, B., Di Muzio, A., Ciccocioppo, F., Sorbi, S., Mata, S., Schenone, A., Grandis, M., Lauria, G., Cazzato, D., Antonini, G., Morino, S., Cocito, D., Zibetti, M., Yokota, T., Ohkubo, T., Kanda, T., Kawai, M., Kaida, K., Onoue, H., Kuwabara, S., Mori, M., Iijima, M., Ohyama, K., Baba, M., Tomiyama, M., Nishiyama, K., Akutsu, T., Yokoyama, K., Kanai, K., van Schaik, I.N., Eftimov, F., Notermans, N.C., Visser, N., Faber, C., Hoeijmakers, J., Rejdak, K., Chyrchel-Paszkiewicz, U., Casanovas Pons, C., Alberti Aguiló, M., Gamez, J., Figueras, M., Marquez Infante, C., Benitez Rivero, S., Lunn, M., Morrow, J., Gosal, D., Lavin, T., Melamed, I., Testori, A., Ajroud-Driss, S., Menichella, D., Simpson, E., Chi-Ho Lai, E., Dimachkie, M., Barohn, R.J., Beydoun, S., Johl, H., Lange, D., Shtilbans, A., Muley, S., Ladha, S., Freimer, M., Kissel, J., Latov, N., Chin, R., Ubogu, E., Mumfrey, S., Rao, T., MacDonald, P., Sharma, K., Gonzalez, G., Allen, J., Walk, D., Hobson-Webb, L., Gable, K., van Schaik, Ivo N, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Mielke, Orell, Durn, Billie L, Cornblath, David R, and Merkies, Ingemar S J

Published
2018
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9. Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies

Author

Merkies, Ingemar S. J., van Schaik, Ivo N., Léger, Jean-Marc, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Durn, Billie L., Cornblath, David R., De Bleecker, Jan L., Sommer, Claudia, Robberecht, Wim, Saarela, Mika, Kamienowski, Jerzy, Stelmasiak, Zbigniew, Tackenberg, Björn, Mielke, Orell, Sabet, A., George, K., Roberts, L., Carne, R., Blum, S., Henderson, R., Van Damme, P., Demeestere, J., Larue, S., D'Amour, C., Kunc, P., Valis, M., Sussova, J., Kalous, T., Talab, R., Bednar, M., Toomsoo, T., Rubanovits, I., Gross-Paju, K., Sorro, U., Saarela, M., Auranen, M., Pouget, J., Attarian, S., Masson, G. Le, Wielanek-Bachelet, A., Desnuelle, C., Delmont, E., Clavelou, P., Aufauvre, D., Schmidt, J., Zschuentzsch, J., Sommer, C., Kramer, D., Hoffmann, O., Goerlitz, C., Haas, J., Chatzopoulos, M., Yoon, R., Gold, R., Berlit, P., Jaspert-Grehl, A., Liebetanz, D., Kutschenko, A., Stangel, M., Trebst, C., Baum, P., Bergh, F., Klehmet, J., Meisel, A., Klostermann, F., Oechtering, J., Lehmann, H., Schroeter, M., Hagenacker, T., Mueller, D., Sperfeld, A., Bethke, F., Drory, V., Algom, A., Yarnitsky, D., Murinson, B., Di Muzio, A., Ciccocioppo, F., Sorbi, S., Mata, S., Schenone, A., Grandis, M., Lauria, G., Cazzato, D., Antonini, G., Morino, S., Cocito, D., Zibetti, M., Yokota, T., Ohkubo, T., Kanda, T., Kawai, M., Kaida, K., Onoue, H., Kuwabara, S., Mori, M., Iijima, M., Ohyama, K., Baba, M., Tomiyama, M., Nishiyama, K., Akutsu, T., Yokoyama, K., Kanai, K., van Schaik, I. N., Eftimov, F., Notermans, N. C., Visser, N., Faber, C., Hoeijmakers, J., Rejdak, K., Chyrchel-Paszkiewicz, U., Casanovas Pons, C., Antonia, M., Gamez, J., Salvado, M., Infante, C. Marquez, Benitez, S., Lunn, M., Morrow, J., Gosal, D., Lavin, T., Melamed, I., Testori, A., Ajroud-Driss, S., Menichella, D., Simpson, E., Lai, E. Chi-Ho, Dimachkie, M., Barohn, R. J., Beydoun, S., Johl, H., Lange, D., Shtilbans, A., Muley, S., Ladha, S., Freimer, M., Kissel, J., Latov, N., Chin, R., Ubogu, E., Mumfrey, S., Rao, T., Macdonald, P., Sharma, K., Gonzalez, G., Allen, J., Walk, D., Hobson-Webb, L., Gable, K., De Bleecker, J. L., Robberecht, W., Franques, J., Léger, J. -M., Morales, R. Juntas, Nguento, A., Schrey, Ch., Kamienowski, J., Stelmasiak, Z., Zwolińska, G., Neurology, AII - Infectious diseases, ANS - Neuroinfection & -inflammation, CSL Behring, Neurologian yksikkö, Clinicum, Department of Food and Nutrition, and HUS Neurocenter

Subjects
Research Report, Male, Outcome Assessment, efficacy, Medizin, Chronic inflammatory demyelinating polyneuropathy, CIDP, IVIG, PATH, PRIMA, Neuroscience (all), Neurology (clinical), INFLAMMATORY DEMYELINATING POLYNEUROPATHY, 3124 Neurology and psychiatry, law.invention, Grip strength, 0302 clinical medicine, Randomized controlled trial, law, Interquartile range, hemic and lymphatic diseases, Outcome Assessment, Health Care, 80 and over, Medicine and Health Sciences, Prospective Studies, Chronic Inflammatory Demyelinating, Prospective cohort study, Aged, 80 and over, education.field_of_study, General Neuroscience, Immunoglobulins, Intravenous, Middle Aged, OPEN-LABEL, humanities, 3. Good health, PREVALENCE, Europe, 030220 oncology & carcinogenesis, Cohort, POLYRADICULONEUROPATHY, Female, Intravenous, Polyneuropathy, Life Sciences & Biomedicine, Adult, medicine.medical_specialty, Efficacy, Neuroscience(all), Population, Clinical Neurology, Immunoglobulins, MAINTENANCE TREATMENT, 03 medical and health sciences, Young Adult, Double-Blind Method, Internal medicine, medicine, Journal Article, Humans, Immunologic Factors, INTRAVENOUS IMMUNOGLOBULIN, Aged, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, education, Science & Technology, business.industry, Neurosciences, 3112 Neurosciences, Research Reports, medicine.disease, PHASE-III, Health Care, cidp, ivig, path, prima, Neurosciences & Neurology, business, 030217 neurology & neurosurgery
Abstract

PRIMA Trial Investigators and the PATH Study Group., 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)‐naïve 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.].

Published
2019

11. 17. Benefit-Risk Profile of Intravenous Immunoglobulin (IVIG) and Subcutaneous Immunoglobulin (SCIG) in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): The PATH study

Author

Shebl, Amgad, primary, Durn, Billie L., additional, Bril, Vera, additional, Merkies, Ingemar S.J., additional, Geloven, Nan, additional, Hartung, Hans-Peter, additional, Lewis, Richard A., additional, Sobue, Gen, additional, Lawo, John-Philip, additional, Cornblath, David R., additional, Mielke, Orell, additional, and van Schaik, Ivo N., additional

Published
2020
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12. 18. Secondary endpoints (PATH extension study): Long-term outcomes of subcutaneous immunoglobulin IgPro20 in CIDP maintenance treatment

Author

van Schaik, Ivo N., primary, Mielke, Orell, additional, Bril, Vera, additional, Hartung, Hans-Peter, additional, Lewis, Richard A., additional, Sobue, Gen, additional, Lawo, John-Philip, additional, Praus, Michaela, additional, Durn, Billie L., additional, Cornblath, David R., additional, and J. Merkies, Ingemar S., additional

Published
2020
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13. 21. Exposure-response of serum IgG levels and INCAT scores in CIDP patients receiving subcutaneous immunoglobulin (IgPro20)

Author

Yuraszeck, Theresa, primary, Lewis, Richard A., additional, Cornblath, David R., additional, Ma, Xuewen, additional, Mielke, Orell, additional, Bril, Vera, additional, Hartung, Hans-Peter, additional, Sobue, Gen, additional, Lawo, John-Philip, additional, Durn, Billie L., additional, J. Merkies, Ingemar S., additional, van Schaik, Ivo N., additional, and Tortoricci, Michael A., additional

Published
2020
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14. 19. Pharmacokinetic modelling and simulation of flexible dosing regimens of subcutaneous immunoglobulin (IgPro20) in CIDP patients

Author

Ma, Xuewen, primary, Lewis, Richard A., additional, Cornblath, David R., additional, Yuraszeck, Theresa, additional, Mielke, Orell, additional, Bril, Vera, additional, Hartung, Hans-Peter, additional, Sobue, Gen, additional, Lawo, John-Philip, additional, Durn, Billie L., additional, J. Merkies, Ingemar S., additional, van Schaik, Ivo N., additional, and Tortoricci, Michael A., additional

Published
2020
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15. Benefit-Risk Profile of Intravenous Immunoglobulin (IVIG) and Subcutaneous Immunoglobulin (SCIG) in CIDP: the PATH Study (S43.004)

Author

Shebl, Amgad, primary, Durn, Billie L., additional, Bril, Vera, additional, Merkies, Ingemar S. J., additional, Hartung, Hans-Peter, additional, Lewis, Richard A., additional, Sobue, Gen, additional, Lawo, John-Philip, additional, Cornblath, David R., additional, Mielke, Orell, additional, and Van Schaik, Ivo N., additional

Published
2019
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16. Placebo Effect in the PATH Study of Subcutaneous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy (S43.006)

Author

Lewis, Richard A., primary, Bril, Vera, additional, van Geloven, Nan, additional, Hartung, Hans-Peter, additional, Sobue, Gen, additional, Mielke, Orell, additional, Lawo, John-Philip, additional, Durn, Billie L., additional, Cornblath, David R., additional, Merkies, Ingemar S. J., additional, and Van Schaik, Ivo N., additional

Published
2019
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17. Long-term Safety and Efficacy of Subcutaneous Immunoglobulin IgPro20 in CIDP: the PATH Extension Study. (S43.005)

Author

van Schaik, Ivo N., primary, Mielke, Orell, additional, Bril, Vera, additional, van Geloven, Nan, additional, Hartung, Hans-Peter, additional, Lewis, Richard A., additional, Sobue, Gen, additional, Lawo, John-Philip, additional, Praus, Micheala, additional, Durn, Billie L., additional, Cornblath, David R., additional, and Merkies, Ingemar S.J., additional

Published
2019
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19. Treatment Satisfaction and Work Productivity in a Clinical Study of IgPro20 Maintenance Treatment of CIDP (P5.2-078)

Author

Hartung, Hans-Peter, primary, Mallick, Rajiv, additional, Bril, Vera, additional, van Geloven, Nan, additional, Lewis, Richard A., additional, Sobue, Gen, additional, Lawo, John-Philip, additional, Mielke, Orell, additional, Durn, Billie L., additional, Cornblath, David R., additional, Merkies, Ingemar S. J., additional, and van Schaik, Ivo N., additional

Published
2019
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20. Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy.

Author

Tortorici, Michael A., Yuraszeck, Theresa, Cornblath, David, Bril, Vera, Hartung, Hans‐Peter, Sobue, Gen, Lewis, Richard A., Merkies, Ingemar S. J., Lawo, John‐Philip, Praus, Michaela, Durn, Billie L., Mielke, Orell, Ma, Xuewen, Jauslin, Petra, Pfister, Marc, and van Schaik, Ivo N.

Subjects
CHRONIC inflammatory demyelinating polyradiculoneuropathy, POLYNEUROPATHIES, TREATMENT effectiveness, IMMUNOGLOBULIN analysis
Abstract

The two main objectives of this analysis were to (i) characterize the relationship between immunoglobulin (Ig) exposure and chronic inflammatory demyelinating polyneuropathy (CIDP) disease severity using data from 171 patients with CIDP who received either subcutaneous Ig (IgPro20; Hizentra®) or placebo (PATH study), and to (ii) simulate and compare exposure coverage with various dosing approaches considering weekly dosing to be the reference dose. IgG pharmacokinetic (PK) parameters, including those from a previous population PK model, were used to predict individual IgG profile and exposure metrics. Treatment‐related changes in Inflammatory Neuropathy Cause and Treatment (INCAT) scores were best described by a maximum effect (Emax) model as a function of ΔIgG (total serum IgG at INCAT score assessment minus baseline IgG levels before intravenous Ig restabilization). Simulations indicate that flexible dosing from daily to biweekly (every other week) provide an exposure coverage equivalent to that of a weekly Ig dose. [ABSTRACT FROM AUTHOR]

Published
2021
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21. Efficacy and safety of IVIG in CIDP : Combined data of the PRIMA and PATH studies

Author

Merkies, Ingemar S J, van Schaik, Ivo N, Léger, Jean-Marc, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Durn, Billie L, Cornblath, David R, De Bleecker, Jan L, Sommer, Claudia, Robberecht, Wim, Saarela, Mika, Kamienowski, Jerzy, Stelmasiak, Zbigniew, Tackenberg, Björn, Mielke, Orell, PRIMA Trial Investigators and the PATH Study Group, Merkies, Ingemar S J, van Schaik, Ivo N, Léger, Jean-Marc, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Durn, Billie L, Cornblath, David R, De Bleecker, Jan L, Sommer, Claudia, Robberecht, Wim, Saarela, Mika, Kamienowski, Jerzy, Stelmasiak, Zbigniew, Tackenberg, Björn, Mielke, Orell, and PRIMA Trial Investigators and the PATH Study Group

Published
2019

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

Author

ZL Neuromusculaire Ziekten Medisch, Brain, Merkies, Ingemar S J, van Schaik, Ivo N, Léger, Jean-Marc, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Durn, Billie L, Cornblath, David R, De Bleecker, Jan L, Sommer, Claudia, Robberecht, Wim, Saarela, Mika, Kamienowski, Jerzy, Stelmasiak, Zbigniew, Tackenberg, Björn, Mielke, Orell, PRIMA Trial Investigators and the PATH Study Group, ZL Neuromusculaire Ziekten Medisch, Brain, Merkies, Ingemar S J, van Schaik, Ivo N, Léger, Jean-Marc, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Durn, Billie L, Cornblath, David R, De Bleecker, Jan L, Sommer, Claudia, Robberecht, Wim, Saarela, Mika, Kamienowski, Jerzy, Stelmasiak, Zbigniew, Tackenberg, Björn, Mielke, Orell, and PRIMA Trial Investigators and the PATH Study Group

Published
2019

23. Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP PATH extension study

Author

CSL Behring, van Schaik, Ivo N., Mielke, Orell, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Durn, Billie L., Cornblath, David R., Merkies, Ingemar S. J., CSL Behring, van Schaik, Ivo N., Mielke, Orell, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Durn, Billie L., Cornblath, David R., and Merkies, Ingemar S. J.

Abstract

[Objective] To investigate the long-term safety and efficacy of weekly subcutaneous IgPro20 (Hizentra, CSL Behring) in chronic inflammatory demyelinating polyneuropathy (CIDP)., [Methods] In a 48-week open-label prospective extension study to the PATH study, patients were initially started on 0.2 g/kg or on 0.4 g/kg weekly and—if clinically stable—switched to 0.2 g/kg weekly after 24 weeks. Upon CIDP relapse on the 0.2 g/kg dose, 0.4 g/kg was (re)initiated. CIDP relapse was defined as a deterioration by at least 1 point in the total adjusted Inflammatory Neuropathy Cause and Treatment score., [Results] Eighty-two patients were enrolled. Sixty-two patients initially received 0.4 g/kg, 20 patients 0.2 g/kg weekly. Seventy-two received both doses during the study. Sixty-six patients (81%) completed the 48-week study duration. Overall relapse rates were 10% in 0.4 g/kg–treated patients and 48% in 0.2 g/kg–treated patients. After dose reduction from 0.4 to 0.2 g/kg, 51% (27/53) of patients relapsed, of whom 92% (24 of 26) improved after reinitiation of the 0.4 g/kg dose. Two-thirds of patients (19/28) who completed the PATH study without relapse remained relapse-free on the 0.2 g/kg dose after dose reduction in the extension study. Sixty-two patients had adverse events (AEs) (76%), of which most were mild or moderate with no related serious AEs., [Conclusions] Subcutaneous treatment with IgPro20 provided long-term benefit at both 0.4 and 0.2 g/kg weekly doses with lower relapse rates on the higher dose. Long-term dosing should be individualized to find the most appropriate dose in a given patient. Classification of evidence This study provides Class IV evidence that for patients with CIDP, long-term treatment with SCIG beyond 24 weeks is safe and efficacious.

Published
2019

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

Author

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

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)‐naïve 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.].

Published
2019

25. Restabilization treatment after intravenous immunoglobulin withdrawal in chronic inflammatory demyelinating polyneuropathy: Results from the pre‐randomization phase of the Polyneuropathy And Treatment with Hizentra study

Author

CSL Behring, Meridian HealthComms, Mielke, Orell, Bril, Vera, Cornblath, David R., Lawo, John-Philip, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Merkies, Ingemar S. J., Sobue, Gen, Durn, Billie L., Shebl, Amgad, van Schaik, Ivo N., CSL Behring, Meridian HealthComms, Mielke, Orell, Bril, Vera, Cornblath, David R., Lawo, John-Philip, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Merkies, Ingemar S. J., Sobue, Gen, Durn, Billie L., Shebl, Amgad, and van Schaik, Ivo N.

Abstract

In patients with chronic inflammatory demyelinating polyneuropathy (CIDP), intravenous immunoglobulin (IVIG) is recommended to be periodically reduced to assess the need for ongoing therapy. However, little is known about the effectiveness of restabilization with IVIG in patients who worsen after IVIG withdrawal. In the Polyneuropathy And Treatment with Hizentra (PATH) study, the pre‐randomization period included sudden stopping of IVIG followed by 12 weeks of observation. Those deteriorating were then restabilized with IVIG. Of 245 subjects who stopped IVIG, 28 did not show signs of clinical deterioration within 12 weeks. Two hundred and seven received IVIG restabilization with an induction dose of 2 g/kg bodyweight (bw) IgPro10 (Privigen, CSL Behring, King of Prussia, Pennsylvania) and maintenance doses of 1 g/kg bw every 3 weeks for up to 13 weeks. Signs of clinical improvement were seen in almost all (n = 188; 91%) subjects. During IVIG restabilization, 35 subjects either did not show CIDP stability (n = 21, analyzed as n = 22 as an additional subject was randomized in error) or withdrew for other reasons (n = 14). Of the 22 subjects who did not achieve clinical stability, follow‐up information in 16 subjects after an additional 4 weeks was obtained. Nine subjects were reported to have improved, leaving a maximum of 27 subjects (13%) who either showed no signs of clinical improvement during the restabilization phase and 4 weeks post‐study or withdrew for other reasons. In conclusion, sudden IVIG withdrawal was effective in detecting ongoing immunoglobulin G dependency with a small risk for subjects not returning to their baseline 17 weeks after withdrawal.

Published
2019

26. Placebo effect in chronic inflammatory demyelinating polyneuropathy: The PATH study and a systematic review.

Author

Lewis, Richard A., Cornblath, David R., Hartung, Hans‐Peter, Sobue, Gens, Lawo, John‐Philip, Mielke, Orell, Durn, Billie L., Bril, Vera, Merkies, Ingemar S. J., Bassett, Paul, Cleasby, Alexa, Schaik, Ivo N., Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, and Demeestere, J

Subjects
THERAPEUTIC use of immunoglobulins, DEMYELINATION, IMMUNOGLOBULINS, META-analysis, PLACEBOS, GUILLAIN-Barre syndrome, STATISTICS, SYSTEMATIC reviews, DISEASE relapse, DATA analysis
Abstract

The Polyneuropathy And Treatment with Hizentra (PATH) study required subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) to show dependency on immunoglobulin G (IgG) and then be restabilized on IgG before being randomized to placebo or one of two doses of subcutaneous immunoglobulin (SCIG). Nineteen of the 51 subjects (37%) randomized to placebo did not relapse over the next 24 weeks. This article explores the reasons for this effect. A post‐hoc analysis of the PATH placebo group was undertaken. A literature search identified other placebo‐controlled CIDP trials for review and comparison. In PATH, subjects randomized to placebo who did not relapse were significantly older, had more severe disease, and took longer to deteriorate in the IgG dependency period compared with those who relapsed. Published trials in CIDP, whose primary endpoint was stability or deterioration, had a mean non‐deterioration (placebo effect) of 43%, while trials with a primary endpoint of improvement had a placebo response of only 11%. Placebo is an important variable in the design of CIDP trials. Trials designed to show clinical improvement will have a significantly lower effect of this phenomenon than those designed to show stability or deterioration. [ABSTRACT FROM AUTHOR]

Published
2020
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27. 046 Efficacy and safety of intravenous immunoglobulin (IVIG) IGPRO10 in chronic inflammatory demyelinating polyneuropathy (CIDP)

Author

Sabet, Arman, primary, Mielke, Orell, additional, Schaik, Ivo N van, additional, Leger, Jean-Marc, additional, Bril, Vera, additional, Gloven, Nan van, additional, Hartung, Hans Peter, additional, Lewis, Richard A, additional, Sobue, Gen, additional, Lawo, John-Philip, additional, Durn, Billie L, additional, Cornblath, David R, additional, Bleecker, Jan LDe, additional, Sommer, Claudia, additional, Robberecht, Wim, additional, Saarela, Mika, additional, Kamienowski, Jerzy, additional, Stelmasiak, Zbigniew, additional, Tackenberg, Bjorn, additional, and Merkies, Ingemar SJ, additional

Published
2018
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28. Intravenous versus subcutaneous immunoglobulin – Authors' reply

Author

van Schaik, Ivo N, primary, Mielke, Orell, additional, Sabet, Arman, additional, George, Koshy, additional, Roberts, Leslie, additional, Carne, Ross, additional, Blum, Stefan, additional, Henderson, Robert, additional, Van Damme, Philip, additional, Demeestere, Jelle, additional, Larue, Sandrine, additional, Pinard D'Amour, Catherine-Andree, additional, Bril, Vera, additional, Breiner, Ari, additional, Kunc, Pavel, additional, Valis, Martin, additional, Sussova, Jana, additional, Kalous, Tomas, additional, Talab, Radomir, additional, Bednar, Michal, additional, Toomsoo, Toomas, additional, Rubanovits, Inna, additional, Gross-Paju, Katrin, additional, Sorro, Ulvi, additional, Saarela, Mika, additional, Auranen, Mari, additional, Pouget, Jean, additional, Attarian, Shahram, additional, Le Masson, Gwendal, additional, Wielanek-Bachelet, Anne-Cécile, additional, Desnuelle, Claude, additional, Delmont, Emilien, additional, Clavelou, Pierre, additional, Aufauvre, Dominique, additional, Schmidt, Jens, additional, Zschuentssch, Jana, additional, Sommer, Claudia, additional, Kramer, Daniela, additional, Hoffmann, Olaf, additional, Goerlitz, Carsten, additional, Haas, Judith, additional, Chatzopoulos, Marko, additional, Yoon, Min-Suk, additional, Gold, Ralf, additional, Berlit, Peter, additional, Jaspert-Grehl, Andrea, additional, Liebetanz, David, additional, Kutschenko, Anna, additional, Stangel, Martin, additional, Trebst, Corinna, additional, Baum, Petra, additional, Then Bergh, Florian, additional, Klehmet, Juliane, additional, Meisel, Andreas, additional, Klostermann, Fabian, additional, Oechtering, Johanna, additional, Lehmann, Helmar, additional, Schroeter, Michael, additional, Hagenacker, Tim, additional, Mueller, Daniel, additional, Sperfeld, Anne-Dorte, additional, Bethke, Florian, additional, Hartung, Hans-Peter, additional, Drory, Vivian, additional, Algom, Avi, additional, Yarnitsky, David, additional, Murinson, Beth Brianna, additional, Di Muzio, Antonio, additional, Ciccocioppo, Fausta, additional, Sorbi, Sandro, additional, Mata, Sabrina, additional, Schenone, Angelo, additional, Grandis, Marina, additional, Lauria, Giuseppe, additional, Cazzato, Daniele, additional, Antonini, Giovanni, additional, Morino, Stefania, additional, Cocito, Dario, additional, Zibetti, Maurizio, additional, Yokota, Takanori, additional, Ohkubo, Takuya, additional, Kanda, Takashi, additional, Kawai, Motoharu, additional, Kaida, Kenichi, additional, Onoue, Hiroyuki, additional, Kuwabara, Satoshi, additional, Mori, Masahiro, additional, Iijima, Masahiro, additional, Ohyama, Ken, additional, Sobue, Gen, additional, Baba, Masayuki, additional, Tomiyama, Masahiko, additional, Nishiyama, Kazutoshi, additional, Akutsu, Tsugio, additional, Yokoyama, Kazumasa, additional, Kanai, Kazuaki, additional, van Schaik, Ivo N., additional, Eftimov, Filip, additional, Notermans, Nicolette. C., additional, Visser, Nora. A., additional, Faber, Catharina, additional, Hoeijmakers, Janneke. G.J., additional, Merkies, Ingemar S.J., additional, van Geloven, Nan, additional, Rejdak, Konrad, additional, Chyrchel-Paszkiewicz, Urszula, additional, Casanovas Pons, Carlos, additional, Alberti Aguiló, María Antonia, additional, Gamez, Josep, additional, Figueras, María, additional, Marquez Infante, Celedonio, additional, Benitez Rivero, Sonia, additional, Lunn, Michael, additional, Morrow, Jasper, additional, Gosal, David, additional, Lavin, Timothy Myles, additional, Melamed, Isaac, additional, Testori, Alessandro, additional, Ajroud-Driss, Senda, additional, Menichella, Daniela, additional, Simpson, Ericka, additional, Chi-Ho Lai, Eugene, additional, Dimachkie, Mazen, additional, Barohn, Richard J., additional, Beydoun, Said, additional, Johl, Harpreet, additional, Lange, Dale, additional, Shtilbans, Alexander, additional, Muley, Suraj, additional, Ladha, Shafeeq, additional, Freimer, Miriam, additional, Kissel, John, additional, Latov, Norman, additional, Chin, Russell, additional, Ubogu, Eroboghene, additional, Mumfrey, Sandi, additional, Rao, T. Hermanth P., additional, MacDonald, Paul, additional, Sharma, Khema, additional, Gonzalez, Ginna, additional, Allen, Jeffrey, additional, Walk, David, additional, Hobson-Webb, Lisa, additional, Gable, Karissa, additional, Lewis, Richard A., additional, Cornblath, David R., additional, Lawo, John-Phillip, additional, Praus, Michaela, additional, and Durn, Billie L., additional

Published
2018
Full Text
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29. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH) : a randomised, double-blind, placebo-controlled, phase 3 trial

Author

van Schaik, Ivo N, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Mielke, Orell, Durn, Billie L, Cornblath, David R, Merkies, Ingemar S J, PATH study group, van Schaik, Ivo N, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Mielke, Orell, Durn, Billie L, Cornblath, David R, Merkies, Ingemar S J, and PATH study group

Published
2018

30. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

ZL Neuromusculaire Ziekten Medisch, Brain, Opleiding Neurologie, van Schaik, Ivo N, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Mielke, Orell, Durn, Billie L, Cornblath, David R, Merkies, Ingemar S J, PATH study group, ZL Neuromusculaire Ziekten Medisch, Brain, Opleiding Neurologie, van Schaik, Ivo N, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Mielke, Orell, Durn, Billie L, Cornblath, David R, Merkies, Ingemar S J, and PATH study group

Published
2018

31. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

van Schaik, Ivo N, primary, Bril, Vera, additional, van Geloven, Nan, additional, Hartung, Hans-Peter, additional, Lewis, Richard A, additional, Sobue, Gen, additional, Lawo, John-Philip, additional, Praus, Michaela, additional, Mielke, Orell, additional, Durn, Billie L, additional, Cornblath, David R, additional, Merkies, Ingemar S J, additional, Sabet, A., additional, George, K., additional, Roberts, L., additional, Carne, R., additional, Blum, S., additional, Henderson, R., additional, Van Damme, P., additional, Demeestere, J., additional, Larue, S., additional, D'Amour, C., additional, Bril, V., additional, Breiner, A., additional, Kunc, P., additional, Valis, M., additional, Sussova, J., additional, Kalous, T., additional, Talab, R., additional, Bednar, M., additional, Toomsoo, T., additional, Rubanovits, I., additional, Gross-Paju, K., additional, Sorro, U., additional, Saarela, M., additional, Auranen, M., additional, Pouget, J., additional, Attarian, S., additional, Le Masson, G., additional, Wielanek-Bachelet, A., additional, Desnuelle, C., additional, Delmont, E., additional, Clavelou, P., additional, Aufauvre, D., additional, Schmidt, J., additional, Zschuentssch, J., additional, Sommer, C., additional, Kramer, D., additional, Hoffmann, O., additional, Goerlitz, C., additional, Haas, J., additional, Chatzopoulos, M., additional, Yoon, R., additional, Gold, R., additional, Berlit, P., additional, Jaspert-Grehl, A., additional, Liebetanz, D., additional, Kutschenko, A., additional, Stangel, M., additional, Trebst, C., additional, Baum, P., additional, Bergh, F., additional, Klehmet, J., additional, Meisel, A., additional, Klostermann, F., additional, Oechtering, J., additional, Lehmann, H., additional, Schroeter, M., additional, Hagenacker, T., additional, Mueller, D., additional, Sperfeld, A., additional, Bethke, F., additional, Drory, V., additional, Algom, A., additional, Yarnitsky, D., additional, Murinson, B., additional, Di Muzio, A., additional, Ciccocioppo, F., additional, Sorbi, S., additional, Mata, S., additional, Schenone, A., additional, Grandis, M., additional, Lauria, G., additional, Cazzato, D., additional, Antonini, G., additional, Morino, S., additional, Cocito, D., additional, Zibetti, M., additional, Yokota, T., additional, Ohkubo, T., additional, Kanda, T., additional, Kawai, M., additional, Kaida, K., additional, Onoue, H., additional, Kuwabara, S., additional, Mori, M., additional, Iijima, M., additional, Ohyama, K., additional, Baba, M., additional, Tomiyama, M., additional, Nishiyama, K., additional, Akutsu, T., additional, Yokoyama, K., additional, Kanai, K., additional, van Schaik, I.N., additional, Eftimov, F., additional, Notermans, N.C., additional, Visser, N., additional, Faber, C., additional, Hoeijmakers, J., additional, Rejdak, K., additional, Chyrchel-Paszkiewicz, U., additional, Casanovas Pons, C., additional, Alberti Aguiló, M., additional, Gamez, J., additional, Figueras, M., additional, Marquez Infante, C., additional, Benitez Rivero, S., additional, Lunn, M., additional, Morrow, J., additional, Gosal, D., additional, Lavin, T., additional, Melamed, I., additional, Testori, A., additional, Ajroud-Driss, S., additional, Menichella, D., additional, Simpson, E., additional, Chi-Ho Lai, E., additional, Dimachkie, M., additional, Barohn, R.J., additional, Beydoun, S., additional, Johl, H., additional, Lange, D., additional, Shtilbans, A., additional, Muley, S., additional, Ladha, S., additional, Freimer, M., additional, Kissel, J., additional, Latov, N., additional, Chin, R., additional, Ubogu, E., additional, Mumfrey, S., additional, Rao, T., additional, MacDonald, P., additional, Sharma, K., additional, Gonzalez, G., additional, Allen, J., additional, Walk, D., additional, Hobson-Webb, L., additional, and Gable, K., additional

Published
2018
Full Text
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33. Intravenous versus subcutaneous immunoglobulin – Authors' reply

Author

Sabet, Arman, George, Koshy, Roberts, Leslie, Carne, Ross, Blum, Stefan, Henderson, Robert, Van Damme, Philip, Demeestere, Jelle, Larue, Sandrine, Pinard D'Amour, Catherine-Andree, Bril, Vera, Breiner, Ari, Kunc, Pavel, Valis, Martin, Sussova, Jana, Kalous, Tomas, Talab, Radomir, Bednar, Michal, Toomsoo, Toomas, Rubanovits, Inna, Gross-Paju, Katrin, Sorro, Ulvi, Saarela, Mika, Auranen, Mari, Pouget, Jean, Attarian, Shahram, Le Masson, Gwendal, Wielanek-Bachelet, Anne-Cécile, Desnuelle, Claude, Delmont, Emilien, Clavelou, Pierre, Aufauvre, Dominique, Schmidt, Jens, Zschuentssch, Jana, Sommer, Claudia, Kramer, Daniela, Hoffmann, Olaf, Goerlitz, Carsten, Haas, Judith, Chatzopoulos, Marko, Yoon, Min-Suk, Gold, Ralf, Berlit, Peter, Jaspert-Grehl, Andrea, Liebetanz, David, Kutschenko, Anna, Stangel, Martin, Trebst, Corinna, Baum, Petra, Then Bergh, Florian, Klehmet, Juliane, Meisel, Andreas, Klostermann, Fabian, Oechtering, Johanna, Lehmann, Helmar, Schroeter, Michael, Hagenacker, Tim, Mueller, Daniel, Sperfeld, Anne-Dorte, Bethke, Florian, Hartung, Hans-Peter, Drory, Vivian, Algom, Avi, Yarnitsky, David, Murinson, Beth Brianna, Di Muzio, Antonio, Ciccocioppo, Fausta, Sorbi, Sandro, Mata, Sabrina, Schenone, Angelo, Grandis, Marina, Lauria, Giuseppe, Cazzato, Daniele, Antonini, Giovanni, Morino, Stefania, Cocito, Dario, Zibetti, Maurizio, Yokota, Takanori, Ohkubo, Takuya, Kanda, Takashi, Kawai, Motoharu, Kaida, Kenichi, Onoue, Hiroyuki, Kuwabara, Satoshi, Mori, Masahiro, Iijima, Masahiro, Ohyama, Ken, Sobue, Gen, Baba, Masayuki, Tomiyama, Masahiko, Nishiyama, Kazutoshi, Akutsu, Tsugio, Yokoyama, Kazumasa, Kanai, Kazuaki, van Schaik, Ivo N., Eftimov, Filip, Notermans, Nicolette. C., Visser, Nora. A., Faber, Catharina, Hoeijmakers, Janneke. G.J., Merkies, Ingemar S.J., van Geloven, Nan, Rejdak, Konrad, Chyrchel-Paszkiewicz, Urszula, Casanovas Pons, Carlos, Alberti Aguiló, María Antonia, Gamez, Josep, Figueras, María, Marquez Infante, Celedonio, Benitez Rivero, Sonia, Lunn, Michael, Morrow, Jasper, Gosal, David, Lavin, Timothy Myles, Melamed, Isaac, Testori, Alessandro, Ajroud-Driss, Senda, Menichella, Daniela, Simpson, Ericka, Chi-Ho Lai, Eugene, Dimachkie, Mazen, Barohn, Richard J., Beydoun, Said, Johl, Harpreet, Lange, Dale, Shtilbans, Alexander, Muley, Suraj, Ladha, Shafeeq, Freimer, Miriam, Kissel, John, Latov, Norman, Chin, Russell, Ubogu, Eroboghene, Mumfrey, Sandi, Rao, T. Hermanth P., MacDonald, Paul, Sharma, Khema, Gonzalez, Ginna, Allen, Jeffrey, Walk, David, Hobson-Webb, Lisa, Gable, Karissa, Lewis, Richard A., Cornblath, David R., Lawo, John-Phillip, Praus, Michaela, Durn, Billie L., Mielke, Orell, and van Schaik, Ivo N

Published
2018
Full Text
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