OSKIRA-4: a phase IIb randomised, placebo-controlled study of the efficacy and safety of fostamatinib monotherapy.
OBJECTIVES: OSKIRA-4 evaluated the efficacy of fostamatinib monotherapy versus placebo on the signs and symptoms of rheumatoid arthritis over 6 weeks by Disease Activity Score C reactive protein (DAS-28(CRP)) and assessed non-inferiority to adalimumab monotherapy at Week 24 by DAS-28(CRP). METHODS:...
| Päätekijät: | , , , , , , , , |
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| Aineistotyyppi: | Journal article |
| Kieli: | English |
| Julkaistu: |
2014
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| _version_ | 1826272035056123904 |
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| author | Taylor, P Genovese, M Greenwood, M Ho, M Nasonov, E Oemar, B Stoilov, R Vencovsky, J Weinblatt, M |
| author_facet | Taylor, P Genovese, M Greenwood, M Ho, M Nasonov, E Oemar, B Stoilov, R Vencovsky, J Weinblatt, M |
| author_sort | Taylor, P |
| collection | OXFORD |
| description | OBJECTIVES: OSKIRA-4 evaluated the efficacy of fostamatinib monotherapy versus placebo on the signs and symptoms of rheumatoid arthritis over 6 weeks by Disease Activity Score C reactive protein (DAS-28(CRP)) and assessed non-inferiority to adalimumab monotherapy at Week 24 by DAS-28(CRP). METHODS: Overall, 279 patients not currently taking disease-modifying antirheumatic drugs were randomised to: (A) fostamatinib 100 mg twice daily for 24 weeks plus placebo injection every 2 weeks (PBOI); (B) fostamatinib 100 mg twice daily for 4 weeks, then 150 mg once daily up to Week 24, plus PBOI; (C) fostamatinib 100 mg twice daily for 4 weeks, then 100 mg once daily up to Week 24, plus PBOI; (D) adalimumab 40 mg every 2 weeks for 24 weeks, plus oral placebo twice daily; or (E) oral placebo twice daily for 6 weeks, plus PBOI, then a switch to arm A or B. RESULTS: Fostamatinib demonstrated a significant improvement in DAS-28(CRP) score from baseline versus placebo at Week 6 for arms A and B, but not C. Fostamatinib was significantly less effective than adalimumab at Week 24 based on DAS-28(CRP). Adverse events observed with fostamatinib treatment were consistent with those reported in previous studies, including hypertension and diarrhoea. CONCLUSIONS: Fostamatinib demonstrated efficacy as monotherapy, showing superior DAS-28(CRP) score changes between baseline and 6 weeks when compared with placebo in treatment arms A and B. However, all fostamatinib regimens demonstrated inferior responses compared with adalimumab at Week 24. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov: NCT01264770. |
| first_indexed | 2024-03-06T22:06:11Z |
| format | Journal article |
| id | oxford-uuid:5039d79c-8950-47cc-8754-fe973d35e33c |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T22:06:11Z |
| publishDate | 2014 |
| record_format | dspace |
| spelling | oxford-uuid:5039d79c-8950-47cc-8754-fe973d35e33c2022-03-26T16:12:18ZOSKIRA-4: a phase IIb randomised, placebo-controlled study of the efficacy and safety of fostamatinib monotherapy.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:5039d79c-8950-47cc-8754-fe973d35e33cEnglishSymplectic Elements at Oxford2014Taylor, PGenovese, MGreenwood, MHo, MNasonov, EOemar, BStoilov, RVencovsky, JWeinblatt, MOBJECTIVES: OSKIRA-4 evaluated the efficacy of fostamatinib monotherapy versus placebo on the signs and symptoms of rheumatoid arthritis over 6 weeks by Disease Activity Score C reactive protein (DAS-28(CRP)) and assessed non-inferiority to adalimumab monotherapy at Week 24 by DAS-28(CRP). METHODS: Overall, 279 patients not currently taking disease-modifying antirheumatic drugs were randomised to: (A) fostamatinib 100 mg twice daily for 24 weeks plus placebo injection every 2 weeks (PBOI); (B) fostamatinib 100 mg twice daily for 4 weeks, then 150 mg once daily up to Week 24, plus PBOI; (C) fostamatinib 100 mg twice daily for 4 weeks, then 100 mg once daily up to Week 24, plus PBOI; (D) adalimumab 40 mg every 2 weeks for 24 weeks, plus oral placebo twice daily; or (E) oral placebo twice daily for 6 weeks, plus PBOI, then a switch to arm A or B. RESULTS: Fostamatinib demonstrated a significant improvement in DAS-28(CRP) score from baseline versus placebo at Week 6 for arms A and B, but not C. Fostamatinib was significantly less effective than adalimumab at Week 24 based on DAS-28(CRP). Adverse events observed with fostamatinib treatment were consistent with those reported in previous studies, including hypertension and diarrhoea. CONCLUSIONS: Fostamatinib demonstrated efficacy as monotherapy, showing superior DAS-28(CRP) score changes between baseline and 6 weeks when compared with placebo in treatment arms A and B. However, all fostamatinib regimens demonstrated inferior responses compared with adalimumab at Week 24. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov: NCT01264770. |
| spellingShingle | Taylor, P Genovese, M Greenwood, M Ho, M Nasonov, E Oemar, B Stoilov, R Vencovsky, J Weinblatt, M OSKIRA-4: a phase IIb randomised, placebo-controlled study of the efficacy and safety of fostamatinib monotherapy. |
| title | OSKIRA-4: a phase IIb randomised, placebo-controlled study of the efficacy and safety of fostamatinib monotherapy. |
| title_full | OSKIRA-4: a phase IIb randomised, placebo-controlled study of the efficacy and safety of fostamatinib monotherapy. |
| title_fullStr | OSKIRA-4: a phase IIb randomised, placebo-controlled study of the efficacy and safety of fostamatinib monotherapy. |
| title_full_unstemmed | OSKIRA-4: a phase IIb randomised, placebo-controlled study of the efficacy and safety of fostamatinib monotherapy. |
| title_short | OSKIRA-4: a phase IIb randomised, placebo-controlled study of the efficacy and safety of fostamatinib monotherapy. |
| title_sort | oskira 4 a phase iib randomised placebo controlled study of the efficacy and safety of fostamatinib monotherapy |
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