| Title |
Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis
|
|---|---|
| Published in |
BioDrugs, June 2017
|
| DOI | 10.1007/s40259-017-0233-6 |
| Pubmed ID | |
| Authors |
Won Park, Chang-Hee Suh, Seung Cheol Shim, Francisco Fidencio Cons Molina, Slawomir Jeka, Francisco G. Medina-Rodriguez, Pawel Hrycaj, Piotr Wiland, Eun Young Lee, Pavel Shesternya, Volodymyr Kovalenko, Leysan Myasoutova, Marina Stanislav, Sebastiao Radominski, Mie Jin Lim, Jung-Yoon Choe, Sang Joon Lee, Sung Young Lee, Sung Hwan Kim, Dae Hyun Yoo |
| Abstract |
CT-P10 is a biosimilar candidate of innovator rituximab (RTX) that demonstrated a comparable clinical profile to RTX in a phase I randomized controlled trial (RCT) in rheumatoid arthritis (RA) (ClinicalTrials.gov identifier: NCT01534884). This open-label extension (OLE) study (NCT01873443) compared the efficacy and safety of CT-P10 in patients with RA who received CT-P10 from the outset (i.e., from the start of the RCT and also in the OLE; 'maintenance group') with those who received RTX during the RCT and switched to CT-P10 during the OLE ('switch group'). Patients who completed the RCT were recruited. Based on the Disease Activity Score using 28 joints (DAS28) and predefined safety criteria, patients could receive up to two courses of CT-P10 during the OLE. Efficacy [DAS28 and European League Against Rheumatism (EULAR) response], safety and immunogenicity were assessed. Eighty-seven patients were enrolled; 58 and 29 had previously received CT-P10 or RTX, respectively, in the RCT. Of these, 38 (65.5%) and 20 (69.0%) were treated with CT-P10 in the OLE and therefore comprised the maintenance and switch groups, respectively. The mean change in DAS28-erythrocyte sedimentation rate (ESR) from baseline (week 0 of RCT) at week 24 of the first OLE treatment course in the maintenance and switch groups was -2.7 and -2.4, respectively. The proportion of patients with good/moderate EULAR responses was also comparable between groups. Antidrug antibodies were detected in 13.2 and 15.0% of patients in the maintenance and switch groups, respectively, at week 24 of the first OLE course. CT-P10 treatment was well-tolerated when administered for up to 2 years or after switching from RTX. In this study population, comparable efficacy and safety profiles were observed in patients who switched from RTX to CT-P10 and those maintained on CT-P10 throughout treatment. |
Mendeley readers
The data shown below were compiled from readership statistics for 87 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 87 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 16 | 18% |
| Student > Master | 16 | 18% |
| Student > Ph. D. Student | 8 | 9% |
| Other | 6 | 7% |
| Student > Bachelor | 4 | 5% |
| Other | 10 | 11% |
| Unknown | 27 | 31% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 23 | 26% |
| Pharmacology, Toxicology and Pharmaceutical Science | 18 | 21% |
| Biochemistry, Genetics and Molecular Biology | 4 | 5% |
| Nursing and Health Professions | 2 | 2% |
| Economics, Econometrics and Finance | 2 | 2% |
| Other | 5 | 6% |
| Unknown | 33 | 38% |
Attention Score in Context
This research output has an Altmetric Attention Score of 7. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 14 June 2017.
All research outputs
#4,214,819
of 22,981,247 outputs
Outputs from BioDrugs
#125
of 660 outputs
Outputs of similar age
#75,195
of 317,132 outputs
Outputs of similar age from BioDrugs
#5
of 11 outputs
Altmetric has tracked 22,981,247 research outputs across all sources so far. Compared to these this one has done well and is in the 80th percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 660 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 6.6. This one has done well, scoring higher than 79% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 317,132 tracked outputs that were published within six weeks on either side of this one in any source. This one has done well, scoring higher than 75% of its contemporaries.
We're also able to compare this research output to 11 others from the same source and published within six weeks on either side of this one. This one is in the 45th percentile – i.e., 45% of its contemporaries scored the same or lower than it.