Abstract | BACKGROUND: METHODS: Patients with active RA (N = 597) were randomly assigned (1:1) to PF-06410293 or adalimumab-EU, while continuing with MTX treatment. The primary endpoint was American College of Rheumatology 20% improvement (ACR20) at week 12. Therapeutic equivalence was concluded if the two-sided 95% confidence interval (CI) for the ACR20 difference between the two arms was entirely contained within the symmetric equivalence margin (±14%). Additionally, a two-sided 90% CI was calculated by using an asymmetric equivalence margin (-12%, 15%). Secondary efficacy endpoints to week 26 included ACR20/50/70, change from baseline Disease Activity Score based on high-sensitivity C-reactive protein [DAS28-4(CRP)], European League Against Rheumatism (EULAR) response, DAS28-4(CRP) of less than 2.6, and ACR/EULAR remission. QuantiFERON-TB testing was performed at screening and week 26. RESULTS: Patients (78.7% of whom were female and whose mean age was 52.5 years) had a mean baseline RA duration of 6.8 years. The mean baseline DAS28-4(CRP) values were 5.9 (PF-06410293) and 6.1 ( adalimumab-EU). The observed week-12 ACR20 values were 68.7% (PF-06410293) and 72.7% ( adalimumab-EU) in the intention-to-treat population. With non-responder imputation, the treatment difference in week-12 ACR20 was -2.98% and corresponding CIs-95% CI (-10.38%, 4.44%) and 90% CI (-9.25%, 3.28%)-were entirely contained within the equivalence margins (symmetric and asymmetric, respectively). The secondary efficacy endpoints were similar between arms. Over 26 weeks, injection-site reactions occurred in 1.7% versus 2.0%, hypersensitivity events in 4.4% versus 8.4%, pneumonia in 0.7% versus 2.0%, and opportunistic infections in 2.4% versus 1.7% in the PF-06410293 and adalimumab-EU arms, respectively. One death due to myocardial infarction occurred ( adalimumab-EU arm). Rates of anti- drug antibody incidence were 44.4% (PF-06410293) and 50.5% ( adalimumab-EU). CONCLUSIONS: The study results demonstrate that efficacy, safety, and immunogenicity of PF-06410293 and adalimumab-EU were similar during the first 26 weeks of treatment in patients with active RA on background MTX. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02480153 . First posted on June 24, 2015; EU Clinical Trials Register EudraCT number: 2014-000352-29 . Start date: October 27, 2014.
|
Authors | Roy M Fleischmann, Rieke Alten, Margarita Pileckyte, Kasia Lobello, Steven Y Hua, Carol Cronenberger, Daniel Alvarez, Amy E Bock, K Lea Sewell |
Journal | Arthritis research & therapy
(Arthritis Res Ther)
Vol. 20
Issue 1
Pg. 178
(08 15 2018)
ISSN: 1478-6362 [Electronic] England |
PMID | 30111357
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Antirheumatic Agents
- Biosimilar Pharmaceuticals
- PF-06410293
- Adalimumab
|
Topics |
- Adalimumab
(therapeutic use)
- Adult
- Aged
- Antirheumatic Agents
(therapeutic use)
- Arthritis, Rheumatoid
(drug therapy)
- Biosimilar Pharmaceuticals
(therapeutic use)
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
|