Safety and efficacy of switching from adalimumab to sarilumab in patients with rheumatoid arthritis in the ongoing MONARCH open-label extension
Objective Evaluate open-label sarilumab monotherapy in patients with rheumatoid arthritis switching from adalimumab monotherapy in MONARCH (NCT02332590); assess long-term safety and efficacy in patients continuing sarilumab during open-label extension (OLE).Methods During the 48-week OLE, patients r...
Saved in:
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2019-10-01
|
| Series: | RMD Open |
| Online Access: | https://rmdopen.bmj.com/content/5/2/e001017.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1825201938729271296 |
|---|---|
| author | Gerd R Burmester Mark C Genovese Vibeke Strand Gregory St John Andrea Rubbert-Roth Howard Amital Tatiana Raskina Antonio Gómez-Centeno Claudia Pena-Rossi Leon Gervitz Karthinathan Thangavelu Susan Boklage |
| author_facet | Gerd R Burmester Mark C Genovese Vibeke Strand Gregory St John Andrea Rubbert-Roth Howard Amital Tatiana Raskina Antonio Gómez-Centeno Claudia Pena-Rossi Leon Gervitz Karthinathan Thangavelu Susan Boklage |
| author_sort | Gerd R Burmester |
| collection | DOAJ |
| description | Objective Evaluate open-label sarilumab monotherapy in patients with rheumatoid arthritis switching from adalimumab monotherapy in MONARCH (NCT02332590); assess long-term safety and efficacy in patients continuing sarilumab during open-label extension (OLE).Methods During the 48-week OLE, patients received sarilumab 200 mg subcutaneously once every 2 weeks. Safety (March 2017 cut-off) and efficacy, including patient-reported outcomes, were evaluated.Results In the double-blind phase, patients receiving sarilumab or adalimumab monotherapy showed meaningful improvements in disease activity; sarilumab was superior to adalimumab for improving signs, symptoms and physical function. Overall, 320/369 patients completing the 24-week double-blind phase entered OLE (155 switched from adalimumab; 165 continued sarilumab). Sarilumab safety profile was consistent with previous reports. Treatment-emergent adverse events were similar between groups; no unexpected safety signals emerged in the first 10 weeks postswitch. Among switch patients, improvement in disease activity was evident at OLE week 12: 47.1%/34.8% had changes ≥1.2 in Disease Activity Score (28 joints) (DAS28)-erythrocyte sedimentation rate/DAS28-C-reactive protein. In switch patients achieving low disease activity (LDA: Clinical Disease Activity Index (CDAI) ≤10; Simplified Disease Activity Index (SDAI) ≤11) by OLE week 24, 70.7%/69.5% sustained CDAI/SDAI LDA at both OLE weeks 36 and 48. Proportions of switch patients achieving CDAI ≤2.8 and SDAI ≤3.3 by OLE week 24 increased through OLE week 48. Improvements postswitch approached continuation-group values, including scores ≥normative values.Conclusions During this OLE, there were no unexpected safety issues in patients switching from adalimumab to sarilumab monotherapy, and disease activity improved in many patients. Patients continuing sarilumab reported safety consistent with prolonged use and had sustained benefit. |
| format | Article |
| id | doaj-art-b7c57bebf5c74234bc07d677e5636666 |
| institution | Kabale University |
| issn | 2056-5933 |
| language | English |
| publishDate | 2019-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | RMD Open |
| spelling | doaj-art-b7c57bebf5c74234bc07d677e56366662025-02-07T18:00:09ZengBMJ Publishing GroupRMD Open2056-59332019-10-015210.1136/rmdopen-2019-001017Safety and efficacy of switching from adalimumab to sarilumab in patients with rheumatoid arthritis in the ongoing MONARCH open-label extensionGerd R Burmester0Mark C Genovese1Vibeke Strand2Gregory St John3Andrea Rubbert-Roth4Howard Amital5Tatiana Raskina6Antonio Gómez-Centeno7Claudia Pena-Rossi8Leon Gervitz9Karthinathan Thangavelu10Susan Boklage11Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, GermanyClinical Development, Gilead Sciences Inc, Foster City, California, USADivision of Immunology/Rheumatology, Stanford University, Palo Alto, California, USA3 Medical Affairs, Regeneron Pharmaceuticals, Tarrytown, New York, USA39 Klinik für Rheumatologie, Kantonsspital St Gallen, St Gallen, SwitzerlandDepartment of Medicine ‘B’ and Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel3FSBEI HE KemSMU MOH, Kemerovo, Russian Federation5Corporació Sanitària Parc Taulí, Barcelona, SpainImmunology and Inflammation, Sanofi, Bridgewater, New Jersey, USAMedical Operations and Effectiveness, Sanofi Genzyme, Cambridge, Massachusetts, USASanofi Genzyme, Boston, MA, United States of AmericaRegeneron Pharmaceuticals, Inc., Tarrytown, United States of AmericaObjective Evaluate open-label sarilumab monotherapy in patients with rheumatoid arthritis switching from adalimumab monotherapy in MONARCH (NCT02332590); assess long-term safety and efficacy in patients continuing sarilumab during open-label extension (OLE).Methods During the 48-week OLE, patients received sarilumab 200 mg subcutaneously once every 2 weeks. Safety (March 2017 cut-off) and efficacy, including patient-reported outcomes, were evaluated.Results In the double-blind phase, patients receiving sarilumab or adalimumab monotherapy showed meaningful improvements in disease activity; sarilumab was superior to adalimumab for improving signs, symptoms and physical function. Overall, 320/369 patients completing the 24-week double-blind phase entered OLE (155 switched from adalimumab; 165 continued sarilumab). Sarilumab safety profile was consistent with previous reports. Treatment-emergent adverse events were similar between groups; no unexpected safety signals emerged in the first 10 weeks postswitch. Among switch patients, improvement in disease activity was evident at OLE week 12: 47.1%/34.8% had changes ≥1.2 in Disease Activity Score (28 joints) (DAS28)-erythrocyte sedimentation rate/DAS28-C-reactive protein. In switch patients achieving low disease activity (LDA: Clinical Disease Activity Index (CDAI) ≤10; Simplified Disease Activity Index (SDAI) ≤11) by OLE week 24, 70.7%/69.5% sustained CDAI/SDAI LDA at both OLE weeks 36 and 48. Proportions of switch patients achieving CDAI ≤2.8 and SDAI ≤3.3 by OLE week 24 increased through OLE week 48. Improvements postswitch approached continuation-group values, including scores ≥normative values.Conclusions During this OLE, there were no unexpected safety issues in patients switching from adalimumab to sarilumab monotherapy, and disease activity improved in many patients. Patients continuing sarilumab reported safety consistent with prolonged use and had sustained benefit.https://rmdopen.bmj.com/content/5/2/e001017.full |
| spellingShingle | Gerd R Burmester Mark C Genovese Vibeke Strand Gregory St John Andrea Rubbert-Roth Howard Amital Tatiana Raskina Antonio Gómez-Centeno Claudia Pena-Rossi Leon Gervitz Karthinathan Thangavelu Susan Boklage Safety and efficacy of switching from adalimumab to sarilumab in patients with rheumatoid arthritis in the ongoing MONARCH open-label extension RMD Open |
| title | Safety and efficacy of switching from adalimumab to sarilumab in patients with rheumatoid arthritis in the ongoing MONARCH open-label extension |
| title_full | Safety and efficacy of switching from adalimumab to sarilumab in patients with rheumatoid arthritis in the ongoing MONARCH open-label extension |
| title_fullStr | Safety and efficacy of switching from adalimumab to sarilumab in patients with rheumatoid arthritis in the ongoing MONARCH open-label extension |
| title_full_unstemmed | Safety and efficacy of switching from adalimumab to sarilumab in patients with rheumatoid arthritis in the ongoing MONARCH open-label extension |
| title_short | Safety and efficacy of switching from adalimumab to sarilumab in patients with rheumatoid arthritis in the ongoing MONARCH open-label extension |
| title_sort | safety and efficacy of switching from adalimumab to sarilumab in patients with rheumatoid arthritis in the ongoing monarch open label extension |
| url | https://rmdopen.bmj.com/content/5/2/e001017.full |
| work_keys_str_mv | AT gerdrburmester safetyandefficacyofswitchingfromadalimumabtosarilumabinpatientswithrheumatoidarthritisintheongoingmonarchopenlabelextension AT markcgenovese safetyandefficacyofswitchingfromadalimumabtosarilumabinpatientswithrheumatoidarthritisintheongoingmonarchopenlabelextension AT vibekestrand safetyandefficacyofswitchingfromadalimumabtosarilumabinpatientswithrheumatoidarthritisintheongoingmonarchopenlabelextension AT gregorystjohn safetyandefficacyofswitchingfromadalimumabtosarilumabinpatientswithrheumatoidarthritisintheongoingmonarchopenlabelextension AT andrearubbertroth safetyandefficacyofswitchingfromadalimumabtosarilumabinpatientswithrheumatoidarthritisintheongoingmonarchopenlabelextension AT howardamital safetyandefficacyofswitchingfromadalimumabtosarilumabinpatientswithrheumatoidarthritisintheongoingmonarchopenlabelextension AT tatianaraskina safetyandefficacyofswitchingfromadalimumabtosarilumabinpatientswithrheumatoidarthritisintheongoingmonarchopenlabelextension AT antoniogomezcenteno safetyandefficacyofswitchingfromadalimumabtosarilumabinpatientswithrheumatoidarthritisintheongoingmonarchopenlabelextension AT claudiapenarossi safetyandefficacyofswitchingfromadalimumabtosarilumabinpatientswithrheumatoidarthritisintheongoingmonarchopenlabelextension AT leongervitz safetyandefficacyofswitchingfromadalimumabtosarilumabinpatientswithrheumatoidarthritisintheongoingmonarchopenlabelextension AT karthinathanthangavelu safetyandefficacyofswitchingfromadalimumabtosarilumabinpatientswithrheumatoidarthritisintheongoingmonarchopenlabelextension AT susanboklage safetyandefficacyofswitchingfromadalimumabtosarilumabinpatientswithrheumatoidarthritisintheongoingmonarchopenlabelextension |