Comparative efficacy and safety of adalimumab biosimilar (BCD-057) and innovator in patients with psoriasis vulgaris. Results of the BCD-057-2/CALYPSO phase III international, multicenter, randomized double-blind clinical trial
The paper gives the results of the phase III clinical trial of adalimumab (ADA) biosimilar, (BCD-057) (BIOCAD, Russia), which demonstrate the clinical equivalence of the biosimilar to the ADA innovator Humira® in patients with moderate and severe psoriasis.Objective. The BCD-057-2/CALYPSO phase III...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
IMA-PRESS LLC
2018-12-01
|
| Series: | Современная ревматология |
| Subjects: | |
| Online Access: | https://mrj.ima-press.net/mrj/article/view/865 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1839574177136246784 |
|---|---|
| author | Т. V. Korotaeva A. V. Samtsov A. L. Bakulev M. M. Kokhan I. K. Minullin O. A. Vylegzhanina V. V. Dubensky B. V. Khalilov A. A. Khotko O. S. Zykova I. V. Chumachenko A. M. Lukyanov A. V. Artemyeva S. I. Derbin E. Yu. Stukalina E. V. Chernyaeva R. A. Ivanov |
| author_facet | Т. V. Korotaeva A. V. Samtsov A. L. Bakulev M. M. Kokhan I. K. Minullin O. A. Vylegzhanina V. V. Dubensky B. V. Khalilov A. A. Khotko O. S. Zykova I. V. Chumachenko A. M. Lukyanov A. V. Artemyeva S. I. Derbin E. Yu. Stukalina E. V. Chernyaeva R. A. Ivanov |
| author_sort | Т. V. Korotaeva |
| collection | DOAJ |
| description | The paper gives the results of the phase III clinical trial of adalimumab (ADA) biosimilar, (BCD-057) (BIOCAD, Russia), which demonstrate the clinical equivalence of the biosimilar to the ADA innovator Humira® in patients with moderate and severe psoriasis.Objective. The BCD-057-2/CALYPSO phase III international, multicenter, randomized double-blind clinical trial of the efficacy and safety of BCD-057 (International Nonproprietary Name (INN): adalimumab, ZAO «BIOCARD», Russia) versus Himura® (INN: adalimumab (OOO «Abbvie») in patients with plaque psoriasis aims to prove the equivalent pharmacokinetics, efficacy, safety, and immunogenicity of these medicines in both direct parallel comparison and subsequent switching from innovator to biosimilar.Patients and methods. The investigation enrolled 346 adult patients diagnosed with moderate to severe plaque psoriasis lasting at least 6 months. After screening, the patients were randomized in a 1:1 ratio into BCD-057 or Humira® groups. At week 24, the patients taking Humira® were re-randomized 1:1 into a group to continue treatment with the ADA innovator or into that to switch to BCD-057. The primary efficacy endpoint was to estimate the proportion of patients who had achieved a 75% improvement in Psoriasis Area and Severity Index (PASI75) at week 16. The secondary endpoints included the assessment of the time course of changes in the skin, nails, degree of itching, and quality of life at weeks 16 and 24. Safety was evaluated from the incidence of treatment-associated adverse events (AEs), cases of severe toxicity (grades 3–4 AEs according to the Common Terminology Criteria Adverse Event (CTCAE) 4.03), cases of early patient withdrawal due to AEs, as well as cases of toxicity potentially associated with the use of tumor necrosis factor-α inhibitors. Immunogenicity was determined using the validated test of patient serum samples for binding antibodies (BAb) and neutralizing antibodies.Results and discussion. The per-protocol population for efficacy evaluation included 342 patients. At week 16, the primary endpoint of PASI75 was shown to be achieved by 62.5% (105/168) and 66.46% (109/164) of the patients in the BCD-057 and Himura® groups, respectively; p=0.45). The difference between the groups in PASI75 responses was 3.22% with 95% confidence interval [-14.25%; 6.32%]. The analysis of additional endpoints revealed no significant differences in the efficacy of the biosimilar and innovator. During 24 weeks of the investigation, treatment-associated AEs were recorded in 31.03 and 25.58% of the patients in the BCD-057 and Humira® groups, respectively (p=0.31). The proportion of patients with BAb detected at 16 weeks of the investigation was 25.44 and 24.07% in the BCD-057 and Humira® groups, respectively (p=0.87).Conclusion. The investigation provided convincing clinical evidence for of the equivalent efficacy, safety, and immunogenicity of BCD-057 and Humira®. |
| format | Article |
| id | doaj-art-dcfec1eedb564d51b6a28f18e8c990d5 |
| institution | Matheson Library |
| issn | 1996-7012 2310-158X |
| language | Russian |
| publishDate | 2018-12-01 |
| publisher | IMA-PRESS LLC |
| record_format | Article |
| series | Современная ревматология |
| spelling | doaj-art-dcfec1eedb564d51b6a28f18e8c990d52025-08-04T14:00:35ZrusIMA-PRESS LLCСовременная ревматология1996-70122310-158X2018-12-01124718410.14412/1996-7012-2018-4-71-842129Comparative efficacy and safety of adalimumab biosimilar (BCD-057) and innovator in patients with psoriasis vulgaris. Results of the BCD-057-2/CALYPSO phase III international, multicenter, randomized double-blind clinical trialТ. V. Korotaeva0A. V. Samtsov1A. L. Bakulev2M. M. Kokhan3I. K. Minullin4O. A. Vylegzhanina5V. V. Dubensky6B. V. Khalilov7A. A. Khotko8O. S. Zykova9I. V. Chumachenko10A. M. Lukyanov11A. V. Artemyeva12S. I. Derbin13E. Yu. Stukalina14E. V. Chernyaeva15R. A. Ivanov16V.A. Nasonova Research Institute of Rheumatology.S.M. Kirov Military Medical Academy, Ministry of Defense of Russia.V.I. Razumovsky Saratov State Medical University, Ministry of Health of Russia.Ural Research Institute of Dermatovenereology and Immunopathology.Republican Dermatovenereology Dispensary.Siberian District Medical Center, Federal Biomedical Agency of Russia.Tver State Medical University, Ministry of Health of Russia.Kazan State Medical University, Ministry of Health of Russia.Clinical Dermatovenereology Dispensary, Ministry of Health of the Krasnodar Territory.Vitebsk Regional Clinical Center of Dermatovenereology and Cosmetology.Mogilev Regional Dermatovenereology Dispensary.City Clinical Dermatovenereology Dispensary.ZAO «BIOCAD».ZAO «BIOCAD».ZAO «BIOCAD».ZAO «BIOCAD».ZAO «BIOCAD».The paper gives the results of the phase III clinical trial of adalimumab (ADA) biosimilar, (BCD-057) (BIOCAD, Russia), which demonstrate the clinical equivalence of the biosimilar to the ADA innovator Humira® in patients with moderate and severe psoriasis.Objective. The BCD-057-2/CALYPSO phase III international, multicenter, randomized double-blind clinical trial of the efficacy and safety of BCD-057 (International Nonproprietary Name (INN): adalimumab, ZAO «BIOCARD», Russia) versus Himura® (INN: adalimumab (OOO «Abbvie») in patients with plaque psoriasis aims to prove the equivalent pharmacokinetics, efficacy, safety, and immunogenicity of these medicines in both direct parallel comparison and subsequent switching from innovator to biosimilar.Patients and methods. The investigation enrolled 346 adult patients diagnosed with moderate to severe plaque psoriasis lasting at least 6 months. After screening, the patients were randomized in a 1:1 ratio into BCD-057 or Humira® groups. At week 24, the patients taking Humira® were re-randomized 1:1 into a group to continue treatment with the ADA innovator or into that to switch to BCD-057. The primary efficacy endpoint was to estimate the proportion of patients who had achieved a 75% improvement in Psoriasis Area and Severity Index (PASI75) at week 16. The secondary endpoints included the assessment of the time course of changes in the skin, nails, degree of itching, and quality of life at weeks 16 and 24. Safety was evaluated from the incidence of treatment-associated adverse events (AEs), cases of severe toxicity (grades 3–4 AEs according to the Common Terminology Criteria Adverse Event (CTCAE) 4.03), cases of early patient withdrawal due to AEs, as well as cases of toxicity potentially associated with the use of tumor necrosis factor-α inhibitors. Immunogenicity was determined using the validated test of patient serum samples for binding antibodies (BAb) and neutralizing antibodies.Results and discussion. The per-protocol population for efficacy evaluation included 342 patients. At week 16, the primary endpoint of PASI75 was shown to be achieved by 62.5% (105/168) and 66.46% (109/164) of the patients in the BCD-057 and Himura® groups, respectively; p=0.45). The difference between the groups in PASI75 responses was 3.22% with 95% confidence interval [-14.25%; 6.32%]. The analysis of additional endpoints revealed no significant differences in the efficacy of the biosimilar and innovator. During 24 weeks of the investigation, treatment-associated AEs were recorded in 31.03 and 25.58% of the patients in the BCD-057 and Humira® groups, respectively (p=0.31). The proportion of patients with BAb detected at 16 weeks of the investigation was 25.44 and 24.07% in the BCD-057 and Humira® groups, respectively (p=0.87).Conclusion. The investigation provided convincing clinical evidence for of the equivalent efficacy, safety, and immunogenicity of BCD-057 and Humira®.https://mrj.ima-press.net/mrj/article/view/865adalimumabbiosimilarbcd-057psoriasis |
| spellingShingle | Т. V. Korotaeva A. V. Samtsov A. L. Bakulev M. M. Kokhan I. K. Minullin O. A. Vylegzhanina V. V. Dubensky B. V. Khalilov A. A. Khotko O. S. Zykova I. V. Chumachenko A. M. Lukyanov A. V. Artemyeva S. I. Derbin E. Yu. Stukalina E. V. Chernyaeva R. A. Ivanov Comparative efficacy and safety of adalimumab biosimilar (BCD-057) and innovator in patients with psoriasis vulgaris. Results of the BCD-057-2/CALYPSO phase III international, multicenter, randomized double-blind clinical trial Современная ревматология adalimumab biosimilar bcd-057 psoriasis |
| title | Comparative efficacy and safety of adalimumab biosimilar (BCD-057) and innovator in patients with psoriasis vulgaris. Results of the BCD-057-2/CALYPSO phase III international, multicenter, randomized double-blind clinical trial |
| title_full | Comparative efficacy and safety of adalimumab biosimilar (BCD-057) and innovator in patients with psoriasis vulgaris. Results of the BCD-057-2/CALYPSO phase III international, multicenter, randomized double-blind clinical trial |
| title_fullStr | Comparative efficacy and safety of adalimumab biosimilar (BCD-057) and innovator in patients with psoriasis vulgaris. Results of the BCD-057-2/CALYPSO phase III international, multicenter, randomized double-blind clinical trial |
| title_full_unstemmed | Comparative efficacy and safety of adalimumab biosimilar (BCD-057) and innovator in patients with psoriasis vulgaris. Results of the BCD-057-2/CALYPSO phase III international, multicenter, randomized double-blind clinical trial |
| title_short | Comparative efficacy and safety of adalimumab biosimilar (BCD-057) and innovator in patients with psoriasis vulgaris. Results of the BCD-057-2/CALYPSO phase III international, multicenter, randomized double-blind clinical trial |
| title_sort | comparative efficacy and safety of adalimumab biosimilar bcd 057 and innovator in patients with psoriasis vulgaris results of the bcd 057 2 calypso phase iii international multicenter randomized double blind clinical trial |
| topic | adalimumab biosimilar bcd-057 psoriasis |
| url | https://mrj.ima-press.net/mrj/article/view/865 |
| work_keys_str_mv | AT tvkorotaeva comparativeefficacyandsafetyofadalimumabbiosimilarbcd057andinnovatorinpatientswithpsoriasisvulgarisresultsofthebcd0572calypsophaseiiiinternationalmulticenterrandomizeddoubleblindclinicaltrial AT avsamtsov comparativeefficacyandsafetyofadalimumabbiosimilarbcd057andinnovatorinpatientswithpsoriasisvulgarisresultsofthebcd0572calypsophaseiiiinternationalmulticenterrandomizeddoubleblindclinicaltrial AT albakulev comparativeefficacyandsafetyofadalimumabbiosimilarbcd057andinnovatorinpatientswithpsoriasisvulgarisresultsofthebcd0572calypsophaseiiiinternationalmulticenterrandomizeddoubleblindclinicaltrial AT mmkokhan comparativeefficacyandsafetyofadalimumabbiosimilarbcd057andinnovatorinpatientswithpsoriasisvulgarisresultsofthebcd0572calypsophaseiiiinternationalmulticenterrandomizeddoubleblindclinicaltrial AT ikminullin comparativeefficacyandsafetyofadalimumabbiosimilarbcd057andinnovatorinpatientswithpsoriasisvulgarisresultsofthebcd0572calypsophaseiiiinternationalmulticenterrandomizeddoubleblindclinicaltrial AT oavylegzhanina comparativeefficacyandsafetyofadalimumabbiosimilarbcd057andinnovatorinpatientswithpsoriasisvulgarisresultsofthebcd0572calypsophaseiiiinternationalmulticenterrandomizeddoubleblindclinicaltrial AT vvdubensky comparativeefficacyandsafetyofadalimumabbiosimilarbcd057andinnovatorinpatientswithpsoriasisvulgarisresultsofthebcd0572calypsophaseiiiinternationalmulticenterrandomizeddoubleblindclinicaltrial AT bvkhalilov comparativeefficacyandsafetyofadalimumabbiosimilarbcd057andinnovatorinpatientswithpsoriasisvulgarisresultsofthebcd0572calypsophaseiiiinternationalmulticenterrandomizeddoubleblindclinicaltrial AT aakhotko comparativeefficacyandsafetyofadalimumabbiosimilarbcd057andinnovatorinpatientswithpsoriasisvulgarisresultsofthebcd0572calypsophaseiiiinternationalmulticenterrandomizeddoubleblindclinicaltrial AT oszykova comparativeefficacyandsafetyofadalimumabbiosimilarbcd057andinnovatorinpatientswithpsoriasisvulgarisresultsofthebcd0572calypsophaseiiiinternationalmulticenterrandomizeddoubleblindclinicaltrial AT ivchumachenko comparativeefficacyandsafetyofadalimumabbiosimilarbcd057andinnovatorinpatientswithpsoriasisvulgarisresultsofthebcd0572calypsophaseiiiinternationalmulticenterrandomizeddoubleblindclinicaltrial AT amlukyanov comparativeefficacyandsafetyofadalimumabbiosimilarbcd057andinnovatorinpatientswithpsoriasisvulgarisresultsofthebcd0572calypsophaseiiiinternationalmulticenterrandomizeddoubleblindclinicaltrial AT avartemyeva comparativeefficacyandsafetyofadalimumabbiosimilarbcd057andinnovatorinpatientswithpsoriasisvulgarisresultsofthebcd0572calypsophaseiiiinternationalmulticenterrandomizeddoubleblindclinicaltrial AT siderbin comparativeefficacyandsafetyofadalimumabbiosimilarbcd057andinnovatorinpatientswithpsoriasisvulgarisresultsofthebcd0572calypsophaseiiiinternationalmulticenterrandomizeddoubleblindclinicaltrial AT eyustukalina comparativeefficacyandsafetyofadalimumabbiosimilarbcd057andinnovatorinpatientswithpsoriasisvulgarisresultsofthebcd0572calypsophaseiiiinternationalmulticenterrandomizeddoubleblindclinicaltrial AT evchernyaeva comparativeefficacyandsafetyofadalimumabbiosimilarbcd057andinnovatorinpatientswithpsoriasisvulgarisresultsofthebcd0572calypsophaseiiiinternationalmulticenterrandomizeddoubleblindclinicaltrial AT raivanov comparativeefficacyandsafetyofadalimumabbiosimilarbcd057andinnovatorinpatientswithpsoriasisvulgarisresultsofthebcd0572calypsophaseiiiinternationalmulticenterrandomizeddoubleblindclinicaltrial |