Cepeginterferon alfa-2b in the treatment of chronic myeloproliferative diseases
Purpose of the study. A comparative evaluation of the effectiveness of different therapeutic strategies in patients with polycythemia vera (PV) and essential thrombocythemia (ET). Materials and methods. Patients with PV or ET, diagnosed according to the criteria WHO 2016 were included in the study....
Main Authors: | , , , , , , , , , , , , |
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Format: | Article |
Language: | Russian |
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"Consilium Medicum" Publishing house
2018-07-01
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Series: | Терапевтический архив |
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Online Access: | https://ter-arkhiv.ru/0040-3660/article/viewFile/32759/pdf |
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doaj-24b0a0e7af394e34811b114da05d6bfc |
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record_format |
Article |
collection |
DOAJ |
language |
Russian |
format |
Article |
sources |
DOAJ |
author |
A L MELIKYAN I N SUBORTSEVA E A GILYAZITDINOVA T I KOLOSHEJNOVA E I PUSTOVAYA E K EGOROVA A M KOVRIGINA A B SUDARIKOV A O ABDULLAEV E G LOMAIA N T SIORDIYA A Yu ZARITSKEY V G SAVCHENKO |
spellingShingle |
A L MELIKYAN I N SUBORTSEVA E A GILYAZITDINOVA T I KOLOSHEJNOVA E I PUSTOVAYA E K EGOROVA A M KOVRIGINA A B SUDARIKOV A O ABDULLAEV E G LOMAIA N T SIORDIYA A Yu ZARITSKEY V G SAVCHENKO Cepeginterferon alfa-2b in the treatment of chronic myeloproliferative diseases Терапевтический архив jak2v617f ce-pegalpha-inf-α-2b pegylated interferon alfa-2a / 2b polycythemia vera essential thrombocythemia |
author_facet |
A L MELIKYAN I N SUBORTSEVA E A GILYAZITDINOVA T I KOLOSHEJNOVA E I PUSTOVAYA E K EGOROVA A M KOVRIGINA A B SUDARIKOV A O ABDULLAEV E G LOMAIA N T SIORDIYA A Yu ZARITSKEY V G SAVCHENKO |
author_sort |
A L MELIKYAN |
title |
Cepeginterferon alfa-2b in the treatment of chronic myeloproliferative diseases |
title_short |
Cepeginterferon alfa-2b in the treatment of chronic myeloproliferative diseases |
title_full |
Cepeginterferon alfa-2b in the treatment of chronic myeloproliferative diseases |
title_fullStr |
Cepeginterferon alfa-2b in the treatment of chronic myeloproliferative diseases |
title_full_unstemmed |
Cepeginterferon alfa-2b in the treatment of chronic myeloproliferative diseases |
title_sort |
cepeginterferon alfa-2b in the treatment of chronic myeloproliferative diseases |
publisher |
"Consilium Medicum" Publishing house |
series |
Терапевтический архив |
issn |
0040-3660 2309-5342 |
publishDate |
2018-07-01 |
description |
Purpose of the study. A comparative evaluation of the effectiveness of different therapeutic strategies in patients with polycythemia vera (PV) and essential thrombocythemia (ET). Materials and methods. Patients with PV or ET, diagnosed according to the criteria WHO 2016 were included in the study. The primary endpoint - 6 months of therapy (clinical-hematological and molecular responses). The secondary endpoint - 12 months of therapy (clinico-hematologic, molecular, histological responses). Sixty three patients were included in the analysis: the first group consisted of 33 patients who received the therapy with ce-pegiterferone alpha-2b (ce-pegalpha-INF-α-2b), 10 of them received previous treatment; the second group - 23 patients btained hydroxycarbamide; the third group - 7 patients were treated with recombinant interferon alpha therapy (rINFα). In comparison groups, differences in age were revealed: patients receiving hydroxycarbamide therapy were older. Phlebotomy occurred in 36% of patients in the first group, 9% in the second group, and 14% in the third group. Results. By the 6th month of therapy, 43% of the patients receiving the ce-pegalpha-INF-α-2b had complete clinical-hematologic response, 36% had partial clinical-hematologic remission and stabilization of the disease was established in 21% cases. No disease progression occured. By the 12th month of therapy, statistically significant differences in terms of efficacy between the different therapeutic groups (p = 0.2462, Fisher's exact test). In all three groups, the allelic load of JAK2V617F decreased: from 50 to 19%, from 22.3 to 15.8%, from 50 to 7.19%, respectively. The lower the allele load positively correlated with better response to therapy, which was observed in all analyzed groups. Hematologic adverse events (AEs) were more frequently observed in patients receiving ce-pegalpha-INF-α-2b therapy. Local reactions developed on 3-7 days of therapy as a hyperemic macula at the injection site. Both these reactions and hair loss did not influence on patient’s condition. In the second group (patients with hydroxycarbamide therapy) there were changes in the skin and mucous membranes: dry skin, stomatitis, and in older patients new keratomas appeared. The flu-like syndrome was the most common adverse event associated with the therapy of ce-pegalpha-INF-α-2b, which fully relived during the first month of therapy. There was only one case with the flu-like syndrome we observed at the 11th month of therapy. As a rule, the biochemical blood test changes did not influence on patient’s condition, were mostly associated with dietary violations, had a tendency to self-resolution and did not require medical interventions. Serious AEs were reported in one case - pulmonary embolism in a patient treated with rINFα. The reasons for the therapy discontinue in group 1: toxic hepatitis, intolerance, by the request of the patient, inadequate efficacy of therapy; in group 2: skin toxicity, in group 3: thromboses. The conclusion. Treatment of ce-pegalpha-INF-α-2b in patients with PV and ET is highly effective - the most patients pbtained clinical and hematological responses. There were no statistically significant differences in these parameters in comparison with hydroxycarbamide and rINFα. The use of the ce-pegalpha-INF-α-2b had an acceptable safety profile. The estimated therapeutic dose should be calculated according to body weight. To reduce the frequency of hematologic AE, titration of the drug dose is required. |
topic |
jak2v617f ce-pegalpha-inf-α-2b pegylated interferon alfa-2a / 2b polycythemia vera essential thrombocythemia |
url |
https://ter-arkhiv.ru/0040-3660/article/viewFile/32759/pdf |
work_keys_str_mv |
AT almelikyan cepeginterferonalfa2binthetreatmentofchronicmyeloproliferativediseases AT insubortseva cepeginterferonalfa2binthetreatmentofchronicmyeloproliferativediseases AT eagilyazitdinova cepeginterferonalfa2binthetreatmentofchronicmyeloproliferativediseases AT tikoloshejnova cepeginterferonalfa2binthetreatmentofchronicmyeloproliferativediseases AT eipustovaya cepeginterferonalfa2binthetreatmentofchronicmyeloproliferativediseases AT ekegorova cepeginterferonalfa2binthetreatmentofchronicmyeloproliferativediseases AT amkovrigina cepeginterferonalfa2binthetreatmentofchronicmyeloproliferativediseases AT absudarikov cepeginterferonalfa2binthetreatmentofchronicmyeloproliferativediseases AT aoabdullaev cepeginterferonalfa2binthetreatmentofchronicmyeloproliferativediseases AT eglomaia cepeginterferonalfa2binthetreatmentofchronicmyeloproliferativediseases AT ntsiordiya cepeginterferonalfa2binthetreatmentofchronicmyeloproliferativediseases AT ayuzaritskey cepeginterferonalfa2binthetreatmentofchronicmyeloproliferativediseases AT vgsavchenko cepeginterferonalfa2binthetreatmentofchronicmyeloproliferativediseases |
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spelling |
doaj-24b0a0e7af394e34811b114da05d6bfc2020-11-25T03:32:38Zrus"Consilium Medicum" Publishing houseТерапевтический архив0040-36602309-53422018-07-01907232910.26442/terarkh201890723-2929511Cepeginterferon alfa-2b in the treatment of chronic myeloproliferative diseasesA L MELIKYAN0I N SUBORTSEVA1E A GILYAZITDINOVA2T I KOLOSHEJNOVA3E I PUSTOVAYA4E K EGOROVA5A M KOVRIGINA6A B SUDARIKOV7A O ABDULLAEV8E G LOMAIA9N T SIORDIYA10A Yu ZARITSKEY11V G SAVCHENKO12National Research Center for hematologyNational Research Center for hematologyNational Research Center for hematologyNational Research Center for hematologyNational Research Center for hematologyNational Research Center for hematologyNational Research Center for hematologyNational Research Center for hematologyNational Research Center for hematologyAlmazov National Medical Research CenterAlmazov National Medical Research CenterAlmazov National Medical Research CenterNational Research Center for hematologyPurpose of the study. A comparative evaluation of the effectiveness of different therapeutic strategies in patients with polycythemia vera (PV) and essential thrombocythemia (ET). Materials and methods. Patients with PV or ET, diagnosed according to the criteria WHO 2016 were included in the study. The primary endpoint - 6 months of therapy (clinical-hematological and molecular responses). The secondary endpoint - 12 months of therapy (clinico-hematologic, molecular, histological responses). Sixty three patients were included in the analysis: the first group consisted of 33 patients who received the therapy with ce-pegiterferone alpha-2b (ce-pegalpha-INF-α-2b), 10 of them received previous treatment; the second group - 23 patients btained hydroxycarbamide; the third group - 7 patients were treated with recombinant interferon alpha therapy (rINFα). In comparison groups, differences in age were revealed: patients receiving hydroxycarbamide therapy were older. Phlebotomy occurred in 36% of patients in the first group, 9% in the second group, and 14% in the third group. Results. By the 6th month of therapy, 43% of the patients receiving the ce-pegalpha-INF-α-2b had complete clinical-hematologic response, 36% had partial clinical-hematologic remission and stabilization of the disease was established in 21% cases. No disease progression occured. By the 12th month of therapy, statistically significant differences in terms of efficacy between the different therapeutic groups (p = 0.2462, Fisher's exact test). In all three groups, the allelic load of JAK2V617F decreased: from 50 to 19%, from 22.3 to 15.8%, from 50 to 7.19%, respectively. The lower the allele load positively correlated with better response to therapy, which was observed in all analyzed groups. Hematologic adverse events (AEs) were more frequently observed in patients receiving ce-pegalpha-INF-α-2b therapy. Local reactions developed on 3-7 days of therapy as a hyperemic macula at the injection site. Both these reactions and hair loss did not influence on patient’s condition. In the second group (patients with hydroxycarbamide therapy) there were changes in the skin and mucous membranes: dry skin, stomatitis, and in older patients new keratomas appeared. The flu-like syndrome was the most common adverse event associated with the therapy of ce-pegalpha-INF-α-2b, which fully relived during the first month of therapy. There was only one case with the flu-like syndrome we observed at the 11th month of therapy. As a rule, the biochemical blood test changes did not influence on patient’s condition, were mostly associated with dietary violations, had a tendency to self-resolution and did not require medical interventions. Serious AEs were reported in one case - pulmonary embolism in a patient treated with rINFα. The reasons for the therapy discontinue in group 1: toxic hepatitis, intolerance, by the request of the patient, inadequate efficacy of therapy; in group 2: skin toxicity, in group 3: thromboses. The conclusion. Treatment of ce-pegalpha-INF-α-2b in patients with PV and ET is highly effective - the most patients pbtained clinical and hematological responses. There were no statistically significant differences in these parameters in comparison with hydroxycarbamide and rINFα. The use of the ce-pegalpha-INF-α-2b had an acceptable safety profile. The estimated therapeutic dose should be calculated according to body weight. To reduce the frequency of hematologic AE, titration of the drug dose is required.https://ter-arkhiv.ru/0040-3660/article/viewFile/32759/pdfjak2v617fce-pegalpha-inf-α-2bpegylated interferon alfa-2a / 2bpolycythemia veraessential thrombocythemia |