CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability Study
Abstract Introduction A 27-week analysis of this phase 3 study demonstrated the interchangeability of the adalimumab biosimilar CT-P17 and reference adalimumab. The current 52-week analysis reports secondary data from the open-label extension period (OLE) of the study. Methods In this randomized, do...
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Adis, Springer Healthcare
2025-03-01
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| Series: | Dermatology and Therapy |
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| Online Access: | https://doi.org/10.1007/s13555-025-01383-5 |
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| author | David M. Pariser Mark G. Lebwohl Janusz Jaworski Jakub Trefler Stefan Daniluk Anna Dudek Wojciech Baran Witold Owczarek Pawel Brzewski Mariusz Sikora Marek Krogulec SungHyun Kim JeeHye Suh EunJin Choi JungBin Cha HyunJin Lee SungJeong Lee John Y. Koo |
| author_facet | David M. Pariser Mark G. Lebwohl Janusz Jaworski Jakub Trefler Stefan Daniluk Anna Dudek Wojciech Baran Witold Owczarek Pawel Brzewski Mariusz Sikora Marek Krogulec SungHyun Kim JeeHye Suh EunJin Choi JungBin Cha HyunJin Lee SungJeong Lee John Y. Koo |
| author_sort | David M. Pariser |
| collection | DOAJ |
| description | Abstract Introduction A 27-week analysis of this phase 3 study demonstrated the interchangeability of the adalimumab biosimilar CT-P17 and reference adalimumab. The current 52-week analysis reports secondary data from the open-label extension period (OLE) of the study. Methods In this randomized, double-blind, active-controlled phase 3 study, adults with moderate-to-severe chronic plaque psoriasis received (via prefilled syringe) 80 mg subcutaneous reference adalimumab on day 1, then 40 mg 1 week later, and every other week (EOW) until week 11. At week 13, patients were randomized (1:1) to continue reference adalimumab (“continuous” group) or undergo repeated switching between CT-P17 and reference adalimumab (“switching” group) until week 25. Thereafter, patients entered an OLE and received 40 mg CT-P17 EOW from week 27 to 49, with an end-of-study visit at week 52. Here we present findings from the OLE. Pharmacokinetics (PK), efficacy (including mean percent improvement from baseline in Psoriasis Area Severity Index [PASI] score), safety, and immunogenicity were evaluated. Post hoc subgroup analyses were also conducted. Results Of 327 patients who initiated the OLE, 152 and 160 patients from the switching group and continuous group, respectively, completed the study. Mean serum concentrations were similar between groups throughout the OLE. Efficacy improvements observed up to week 27 were maintained during the OLE and were comparable between groups. At week 52, overall mean (standard deviation [SD]) improvement from baseline in PASI score was 90.34% (16.59). Safety profiles were similar between groups, and immunogenicity did not increase during the OLE. The mean (SD) percent improvement from baseline in PASI score was slightly lower in patients who were antidrug antibody (ADA)-positive versus those who were ADA-negative (89.57 [17.27] versus 97.29 [4.08]) at week 52. Conclusions PK, efficacy, safety, and immunogenicity findings remained consistent throughout the OLE, regardless of prior treatment, and were generally comparable across timepoints. Trial registration ClinicalTrials.gov: NCT05495568. |
| format | Article |
| id | doaj-art-e9f0388f9cc64179b191807db3747104 |
| institution | OA Journals |
| issn | 2193-8210 2190-9172 |
| language | English |
| publishDate | 2025-03-01 |
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| series | Dermatology and Therapy |
| spelling | doaj-art-e9f0388f9cc64179b191807db37471042025-08-20T02:30:20ZengAdis, Springer HealthcareDermatology and Therapy2193-82102190-91722025-03-011551079109210.1007/s13555-025-01383-5CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability StudyDavid M. Pariser0Mark G. Lebwohl1Janusz Jaworski2Jakub Trefler3Stefan Daniluk4Anna Dudek5Wojciech Baran6Witold Owczarek7Pawel Brzewski8Mariusz Sikora9Marek Krogulec10SungHyun Kim11JeeHye Suh12EunJin Choi13JungBin Cha14HyunJin Lee15SungJeong Lee16John Y. Koo17Eastern Virginia Medical School and Virginia Clinical Research, Inc.Icahn School of Medicine at Mount SinaiCentrum Medyczne Reuma ParkReuma CentrumClinicMed Daniluk, Nowak Sp.k.Centrum Medyczne AMEDDepartment of Dermatology, Venereology and Allergology, Wrocław Medical UniversityRoyaldermSpecjalistyczny Gabinet Dermatologiczny Aplikacyjno-BadawczyNational Institute of Geriatrics, Rheumatology and RehabilitationRheumatology Clinic, NZOZ Lecznica MAK-MEDCelltrion, Inc.Celltrion, Inc.Celltrion, Inc.Celltrion, Inc.Celltrion, Inc.Celltrion, Inc.UCSF Psoriasis and Skin Treatment CenterAbstract Introduction A 27-week analysis of this phase 3 study demonstrated the interchangeability of the adalimumab biosimilar CT-P17 and reference adalimumab. The current 52-week analysis reports secondary data from the open-label extension period (OLE) of the study. Methods In this randomized, double-blind, active-controlled phase 3 study, adults with moderate-to-severe chronic plaque psoriasis received (via prefilled syringe) 80 mg subcutaneous reference adalimumab on day 1, then 40 mg 1 week later, and every other week (EOW) until week 11. At week 13, patients were randomized (1:1) to continue reference adalimumab (“continuous” group) or undergo repeated switching between CT-P17 and reference adalimumab (“switching” group) until week 25. Thereafter, patients entered an OLE and received 40 mg CT-P17 EOW from week 27 to 49, with an end-of-study visit at week 52. Here we present findings from the OLE. Pharmacokinetics (PK), efficacy (including mean percent improvement from baseline in Psoriasis Area Severity Index [PASI] score), safety, and immunogenicity were evaluated. Post hoc subgroup analyses were also conducted. Results Of 327 patients who initiated the OLE, 152 and 160 patients from the switching group and continuous group, respectively, completed the study. Mean serum concentrations were similar between groups throughout the OLE. Efficacy improvements observed up to week 27 were maintained during the OLE and were comparable between groups. At week 52, overall mean (standard deviation [SD]) improvement from baseline in PASI score was 90.34% (16.59). Safety profiles were similar between groups, and immunogenicity did not increase during the OLE. The mean (SD) percent improvement from baseline in PASI score was slightly lower in patients who were antidrug antibody (ADA)-positive versus those who were ADA-negative (89.57 [17.27] versus 97.29 [4.08]) at week 52. Conclusions PK, efficacy, safety, and immunogenicity findings remained consistent throughout the OLE, regardless of prior treatment, and were generally comparable across timepoints. Trial registration ClinicalTrials.gov: NCT05495568.https://doi.org/10.1007/s13555-025-01383-5AdalimumabBiosimilarCT-P17InterchangeabilityPsoriasisSwitching |
| spellingShingle | David M. Pariser Mark G. Lebwohl Janusz Jaworski Jakub Trefler Stefan Daniluk Anna Dudek Wojciech Baran Witold Owczarek Pawel Brzewski Mariusz Sikora Marek Krogulec SungHyun Kim JeeHye Suh EunJin Choi JungBin Cha HyunJin Lee SungJeong Lee John Y. Koo CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability Study Dermatology and Therapy Adalimumab Biosimilar CT-P17 Interchangeability Psoriasis Switching |
| title | CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability Study |
| title_full | CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability Study |
| title_fullStr | CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability Study |
| title_full_unstemmed | CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability Study |
| title_short | CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability Study |
| title_sort | ct p17 adalimumab biosimilar in patients with moderate to severe chronic plaque psoriasis an open label extension of a phase 3 interchangeability study |
| topic | Adalimumab Biosimilar CT-P17 Interchangeability Psoriasis Switching |
| url | https://doi.org/10.1007/s13555-025-01383-5 |
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