Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial
Objective To assess the long-term (3 year) efficacy and safety of secukinumab in patients with active psoriatic arthritis (PsA) in the extension phase of the FUTURE 1 study (NCT01892436).Methods Following the 2-year core trial, eligible patients receiving subcutaneous secukinumab 150 or 75 mg entere...
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| Format: | Article |
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BMJ Publishing Group
2018-08-01
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| Series: | RMD Open |
| Online Access: | https://rmdopen.bmj.com/content/4/2/e000723.full |
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| author | Philip J Mease Arthur Kavanaugh Andreas Reimold Hasan Tahir Jürgen Rech Stephen Hall Piet Geusens Pascale Pellet Evie Maria Delicha Shephard Mpofu Luminita Pricop |
| author_facet | Philip J Mease Arthur Kavanaugh Andreas Reimold Hasan Tahir Jürgen Rech Stephen Hall Piet Geusens Pascale Pellet Evie Maria Delicha Shephard Mpofu Luminita Pricop |
| author_sort | Philip J Mease |
| collection | DOAJ |
| description | Objective To assess the long-term (3 year) efficacy and safety of secukinumab in patients with active psoriatic arthritis (PsA) in the extension phase of the FUTURE 1 study (NCT01892436).Methods Following the 2-year core trial, eligible patients receiving subcutaneous secukinumab 150 or 75 mg entered a 3-year extension phase. Results are presented for key efficacy and safety endpoints at week 156.Results In total, 460 patients entered the extension study; 308 patients originally randomised to secukinumab were assessed for efficacy. Sustained improvements in all efficacy endpoints were achieved with secukinumab through week 156. Overall, 76.8%/54.9% (secukinumab 150 mg) and 65.2%/39.0% (secukinumab 75 mg) of patients achieved an American College of Rheumatology (ACR) 20/50 response (multiple imputation data); ACR20 responses were sustained irrespective of previous anti-tumour necrosis factor exposure. Improvements in quality of life and physical function were also sustained through week 156. Radiographic results (observed data; van der Heijde modified total Sharp score (mTSS)) showed that 78.1% (secukinumab 150 mg) and 74.8% (secukinumab 75 mg) of patients had no radiographic progression (≤0.5 increase in mTSS) through week 156. Exposure-adjusted incidence rates for selected adverse events per 100 patient-years (secukinumab 150/75 mg) were serious infections (1.7/1.6), Candida infections (1.4/0.7), Crohn’s disease (0/0.3), ulcerative colitis (0/0.3) and major adverse cardiac events (0.3/0.8).Conclusion Subcutaneous secukinumab provided sustained improvements in the signs and symptoms, quality of life and physical function of patients with active PsA with low rate of radiographic disease progression through 3 years. Secukinumab was well tolerated with no new safety signals. |
| format | Article |
| id | doaj-art-b0fa139dc8754190abd5d8b31638952e |
| institution | Kabale University |
| issn | 2056-5933 |
| language | English |
| publishDate | 2018-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | RMD Open |
| spelling | doaj-art-b0fa139dc8754190abd5d8b31638952e2025-02-08T09:15:09ZengBMJ Publishing GroupRMD Open2056-59332018-08-014210.1136/rmdopen-2018-000723Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trialPhilip J Mease0Arthur Kavanaugh1Andreas Reimold2Hasan Tahir3Jürgen Rech4Stephen Hall5Piet Geusens6Pascale Pellet7Evie Maria Delicha8Shephard Mpofu9Luminita Pricop10University of Washington School of Medicine, Seattle, Washington, USADivision of Rheumatology, Autoimmunity and Inflammation, University of California San Diego, La Jolla, California, USA3Dallas VA Medical Center and University of Texas Southwestern Medical Center, Dallas, United States of America4Barts Health NHS Trust, London, United Kingdom5Universitätsklinikum Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, GermanyRheumatology, Emeritus Research and Monash University, Melbourne, Victoria, AustraliaDepartment of Internal Medicine, Subdivision Rheumatology, Research School CAPHRI, Maastricht Univeristy Medical Centre, Maastricht, The Netherlands9Novartis Pharma AG, Basel, Switzerland9 Novartis Pharma AG, Basel, Switzerland9Novartis Pharma AG, Basel, Switzerland10Novartis Pharmaceuticals Corporation, East Hanover, United States of AmericaObjective To assess the long-term (3 year) efficacy and safety of secukinumab in patients with active psoriatic arthritis (PsA) in the extension phase of the FUTURE 1 study (NCT01892436).Methods Following the 2-year core trial, eligible patients receiving subcutaneous secukinumab 150 or 75 mg entered a 3-year extension phase. Results are presented for key efficacy and safety endpoints at week 156.Results In total, 460 patients entered the extension study; 308 patients originally randomised to secukinumab were assessed for efficacy. Sustained improvements in all efficacy endpoints were achieved with secukinumab through week 156. Overall, 76.8%/54.9% (secukinumab 150 mg) and 65.2%/39.0% (secukinumab 75 mg) of patients achieved an American College of Rheumatology (ACR) 20/50 response (multiple imputation data); ACR20 responses were sustained irrespective of previous anti-tumour necrosis factor exposure. Improvements in quality of life and physical function were also sustained through week 156. Radiographic results (observed data; van der Heijde modified total Sharp score (mTSS)) showed that 78.1% (secukinumab 150 mg) and 74.8% (secukinumab 75 mg) of patients had no radiographic progression (≤0.5 increase in mTSS) through week 156. Exposure-adjusted incidence rates for selected adverse events per 100 patient-years (secukinumab 150/75 mg) were serious infections (1.7/1.6), Candida infections (1.4/0.7), Crohn’s disease (0/0.3), ulcerative colitis (0/0.3) and major adverse cardiac events (0.3/0.8).Conclusion Subcutaneous secukinumab provided sustained improvements in the signs and symptoms, quality of life and physical function of patients with active PsA with low rate of radiographic disease progression through 3 years. Secukinumab was well tolerated with no new safety signals.https://rmdopen.bmj.com/content/4/2/e000723.full |
| spellingShingle | Philip J Mease Arthur Kavanaugh Andreas Reimold Hasan Tahir Jürgen Rech Stephen Hall Piet Geusens Pascale Pellet Evie Maria Delicha Shephard Mpofu Luminita Pricop Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial RMD Open |
| title | Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial |
| title_full | Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial |
| title_fullStr | Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial |
| title_full_unstemmed | Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial |
| title_short | Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial |
| title_sort | secukinumab in the treatment of psoriatic arthritis efficacy and safety results through 3 years from the year 1 extension of the randomised phase iii future 1 trial |
| url | https://rmdopen.bmj.com/content/4/2/e000723.full |
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