Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment
Objective. To report long-term safety and tolerability of olokizumab (OKZ) in combination with methotrexate (MTX) in subjects with active rheumatoid arthritis (RA), using pooled data from three randomised clinical trials (RCT) followed by open-label extension (OLE) study.Methods. Cumulative data fro...
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| Format: | Article |
| Language: | Russian |
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IMA-PRESS LLC
2024-12-01
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| Series: | Современная ревматология |
| Online Access: | https://mrj.ima-press.net/mrj/article/view/1663 |
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| author | Eugen Feist Roy M. Fleischmann Saeed Fatenejad Daria Bukhanova Sergey Grishin Sofia Kuzkina Michael Luggen Evgeniy Nasonov Mikhail Samsonov Josef S. Smolen |
| author_facet | Eugen Feist Roy M. Fleischmann Saeed Fatenejad Daria Bukhanova Sergey Grishin Sofia Kuzkina Michael Luggen Evgeniy Nasonov Mikhail Samsonov Josef S. Smolen |
| author_sort | Eugen Feist |
| collection | DOAJ |
| description | Objective. To report long-term safety and tolerability of olokizumab (OKZ) in combination with methotrexate (MTX) in subjects with active rheumatoid arthritis (RA), using pooled data from three randomised clinical trials (RCT) followed by open-label extension (OLE) study.Methods. Cumulative data from three phase 3 core trials and their OLE were analysed. Safety variables assessed included treatment-emergent adverse events (AEs), serious AEs (SAEs), AEs of special interest and laboratory results. Efficacy assessments included ACR20/50/70 responses, Disease Activity Score 28 (C-reactive protein) <3.2, CDAI remission and low disease activity (LDA), SDAI remission and LDA, HAQ-DI decrease of 0.22 unit and Boolean 2.0 remission.Results. A total of 2304 patients received OKZ in combination with MTX either once every 2 weeks or once every 4 weeks. Event rates per 100 patient-years in OKZ every 2 weeks and OKZ every 4 weeks, respectively, were 9.57 and 9.13 for SAEs; 2.95 and 2.34 for serious infections; 0.09 and 0.05 for gastrointestinal perforations; 0.58 and 0.83 for major adverse cardiovascular events; and 0.45 and 0.50 for malignancies. No increase in the rate of any AE was observed over 106 weeks of treatment. The evaluation of laboratory variables demonstrated the expected changes, like neutropenia, elevation of liver enzymes and blood lipids. Clinical response rates remained stable during the OLE.Conclusion. The long-term safety and tolerability of OKZ in combination with MTX remained stable. The efficacy of OKZ was maintained through week 106. These findings support OKZ as a treatment option for patients with active RA. |
| format | Article |
| id | doaj-art-b1bb6436294d4a53893aed51dc01842f |
| institution | DOAJ |
| issn | 1996-7012 2310-158X |
| language | Russian |
| publishDate | 2024-12-01 |
| publisher | IMA-PRESS LLC |
| record_format | Article |
| series | Современная ревматология |
| spelling | doaj-art-b1bb6436294d4a53893aed51dc01842f2025-08-20T03:20:58ZrusIMA-PRESS LLCСовременная ревматология1996-70122310-158X2024-12-01186213510.14412/1996-7012-2024-6-21-352734Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatmentEugen Feist0Roy M. Fleischmann1Saeed Fatenejad2Daria Bukhanova3Sergey Grishin4Sofia Kuzkina5Michael Luggen6Evgeniy Nasonov7Mikhail Samsonov8Josef S. Smolen9Rheumatology and Clinical Immunology, HELIOS Fachklinik Vogelsang/Gommern; Experimental Rheumatology, Otto-von-Guericke University MagdeburgMedicine University of Texas Southwestern; Metroplex Clinical Research CenterSFC Medica, LLCR-Pharm JSCR-Pharm JSCR-Pharm JSCUniversity of Cincinnati College of MedicineV.A. Nasonova Research Institute of Rheumatology; I.M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of RussiaR-Pharm JSCDivision of Rheumatology, Department of Medicine 3, Medical University of ViennaObjective. To report long-term safety and tolerability of olokizumab (OKZ) in combination with methotrexate (MTX) in subjects with active rheumatoid arthritis (RA), using pooled data from three randomised clinical trials (RCT) followed by open-label extension (OLE) study.Methods. Cumulative data from three phase 3 core trials and their OLE were analysed. Safety variables assessed included treatment-emergent adverse events (AEs), serious AEs (SAEs), AEs of special interest and laboratory results. Efficacy assessments included ACR20/50/70 responses, Disease Activity Score 28 (C-reactive protein) <3.2, CDAI remission and low disease activity (LDA), SDAI remission and LDA, HAQ-DI decrease of 0.22 unit and Boolean 2.0 remission.Results. A total of 2304 patients received OKZ in combination with MTX either once every 2 weeks or once every 4 weeks. Event rates per 100 patient-years in OKZ every 2 weeks and OKZ every 4 weeks, respectively, were 9.57 and 9.13 for SAEs; 2.95 and 2.34 for serious infections; 0.09 and 0.05 for gastrointestinal perforations; 0.58 and 0.83 for major adverse cardiovascular events; and 0.45 and 0.50 for malignancies. No increase in the rate of any AE was observed over 106 weeks of treatment. The evaluation of laboratory variables demonstrated the expected changes, like neutropenia, elevation of liver enzymes and blood lipids. Clinical response rates remained stable during the OLE.Conclusion. The long-term safety and tolerability of OKZ in combination with MTX remained stable. The efficacy of OKZ was maintained through week 106. These findings support OKZ as a treatment option for patients with active RA.https://mrj.ima-press.net/mrj/article/view/1663 |
| spellingShingle | Eugen Feist Roy M. Fleischmann Saeed Fatenejad Daria Bukhanova Sergey Grishin Sofia Kuzkina Michael Luggen Evgeniy Nasonov Mikhail Samsonov Josef S. Smolen Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment Современная ревматология |
| title | Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment |
| title_full | Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment |
| title_fullStr | Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment |
| title_full_unstemmed | Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment |
| title_short | Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment |
| title_sort | olokizumab plus methotrexate safety and efficacy over 106 weeks of treatment |
| url | https://mrj.ima-press.net/mrj/article/view/1663 |
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