Siva Narayanan and co-authors from Ipsos Healthcare assessed the clinical characteristics of patients with rheumatoid arthritis (RA) considered suitable for biosimilar infliximab (when it becomes available) by their physicians. These characteristics were compared to those in patients who were not considered suitable for biosimilar infliximab in the European Union (EU) [1].

A medical chart-review study of RA patients was conducted among physicians (primarily rheumatologists) in hospitals/private practices in the UK, France, Germany, Italy and Spain (5EU) to collect de-identified data on patient diagnosis, treatment patterns/dynamics and patient symptomatology/disease status. Physicians identified whether the patient was suitable for biosimilar infliximab (yes/no), and if yes, rated how likely they would be to prescribe biosimilar infliximab to them when the product becomes available. Physicians were screened for practice duration and patient volume and recruited from a large panel to ensure that the sample was geographically representative. Consecutive patients currently on (or discontinued within the past three months) a biological drug and visiting each centre during the screening period were selected for chart abstraction. The analysis compared patients that were considered suitable for biosimilar infliximab to those who were not (per physician judgement), excluding those who previously failed on infliximab.

A total of 1,204 patients (UK: 239; France: 233; Germany: 229; Italy: 252; Spain: 251) were included in the analysis. Of those, 425 patients (35%; UK: 46%; France: 27%; Germany: 36%; Italy: 41%; Spain: 27%) were identified by physicians as being suitable for biosimilar infliximab. Of these patients, 55% and 26% were rated ≥ 5 and 4 [scale: 7 (extremely likely) to 1 (not at all likely)], respectively, regarding the likelihood of being prescribed biosimilar infliximab. For patients considered suitable for biosimilar infliximab Yes/No groups, mean age: 50.2/51.6 yrs; female: 73% (both groups); time since diagnosis: 67.1/85.3 months; mean # of lines of past biological/oral-DMARD use: 1.2/1.4, score of ≥ 5 on patient involvement in treatment decisions: 64%/56% [scale: 7 (very much involved) to 1 (not at all involved)]. Current treatments included: biological-DMARD: 95%/94%, non-biological-DMARD: 63%/60%, steroids: 20%/27%, NSAIDs:  23%/18%, analgesics: 21%/13%, physical therapy: 11%/5% for patients considered suitable for biosimilar infliximab: Yes/No, respectively. The percentage of patients with moderate/severe disease (per physician judgement) was 46% and 40% for patients considered suitable for biosimilar infliximab: Yes/No, respectively. Among those with available data, recent lab/disease measures were: ESR(23.4/21.2mm/h) and CRP(12.6/8.1mg/dL); VAS(0−10 scale; 3.7/3.4), Swollen Joint Count (2.6/1.9) and Tender Joint Count (4.4/3.1) for patients considered suitable for biosimilar infliximab: Yes/No, respectively.

The results showed that RA patients considered suitable for biosimilar infliximab (per clinical judgement) had been in care for a relatively shorter period, had higher disease severity and were more involved in treatment decisions. They also revealed that physicians were not readily prepared to prescribe the biosimilar to all RA patients considered suitable for biosimilar infliximab. The authors concluded that further scrutiny is warranted to understand the drivers behind physician perception of the suitability of RA patients for biosimilar infliximab.

Biosimilar infliximab (Inflectra/Remsima) was approved by the European Medicines Agency (EMA) in September 2013 [2]. Pfizer announced on 17 October 2016 that it would begin shipment of its monoclonal antibody biosimilar Inflectra (infliximab-dyyb) to the US in late November 2016 [3].

Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.

Abstracted by Siva Narayanan, Executive Vice President, Market Access Solutions, Raritan, USA.

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References
1.    Narayanan S, Lu Y, Hutchings R, Baskett A, Mentzer S. Patients with rheumatoid arthritis identified as potentially suitable for biosimilar infliximab in Europe. Int J Sci Res (IJSR). 2016;5(8):145-9.
2.    GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 27]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3.    GaBI Online - Generics and Biosimilars Initiative. Pfizer to launch infliximab biosimilar Inflectra in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 27]. Available from: www.gabionline.net/Biosimilars/News/Pfizer-to-launch-infliximab-biosimilar-Inflectra-in-US

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