A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2018-08-15

AUTHORS

Roy M. Fleischmann, Rieke Alten, Margarita Pileckyte, Kasia Lobello, Steven Y. Hua, Carol Cronenberger, Daniel Alvarez, Amy E. Bock, K. Lea Sewell

ABSTRACT

BACKGROUND: This double-blind, randomized, 78-week study evaluated the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of PF-06410293, a candidate adalimumab biosimilar, versus adalimumab reference product (Humira®) sourced from the EU (adalimumab-EU) in biologic-naïve patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) (10-25 mg/week). We report results for the first 26 weeks of treatment. 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. More... »

PAGES

178

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s13075-018-1676-y

DOI

http://dx.doi.org/10.1186/s13075-018-1676-y

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1106151500

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30111357


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43 NCT02480153
44 PF-06410293
45 QuantiFERON-TB testing
46 RA duration
47 Register EudraCT number
48 Rheumatism (EULAR) response
49 Rheumatology 20
50 Trials Register EudraCT number
51 active rheumatoid arthritis
52 activity score
53 adalimumab biosimilar
54 adalimumab reference product
55 adalimumab-EU
56 adalimumab-EU arms
57 anti-drug antibody incidence
58 antibody incidence
59 arm
60 arthritis
61 asymmetric equivalence margin
62 background methotrexate
63 baseline DAS28
64 baseline Disease Activity Score
65 baseline RA duration
66 biologic-naïve patients
67 biosimilars
68 candidate adalimumab biosimilar
69 changes
70 clinical studies
71 comparative clinical study
72 confidence intervals
73 corresponding CIs-95
74 date
75 death
76 differences
77 duration
78 efficacy
79 efficacy endpoint
80 endpoint
81 equivalence
82 equivalence margin
83 events
84 hypersensitivity events
85 identifiers
86 immunogenicity
87 improvement
88 imputation
89 incidence
90 infarction
91 infection
92 injection site reactions
93 intention
94 intervals
95 margin
96 mean baseline DAS28
97 mean baseline RA duration
98 methotrexate
99 myocardial infarction
100 non-responder imputation
101 number
102 observed week-12 ACR20 values
103 opportunistic infections
104 patients
105 pharmacodynamics
106 pharmacokinetics
107 pneumonia
108 population
109 primary endpoint
110 products
111 protein
112 rate
113 reaction
114 reactive protein
115 reference product
116 remission
117 response
118 results
119 rheumatoid arthritis
120 safety
121 scores
122 screening
123 secondary efficacy endpoints
124 study
125 study results
126 symmetric equivalence margin
127 testing
128 therapeutic equivalence
129 treat population
130 treatment
131 treatment differences
132 values
133 week 12
134 week 26
135 week-12 ACR20
136 week-12 ACR20 values
137 weeks
138 weeks of treatment
139 years
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