Key study design elements for adalimumab biosimilar studies in rheumatoid arthritis*
| Company | Amgen | Boehringer Ingelheim | Fuji Film Kyowa Kirin Biologics | Pfizer | Samsung Bioepis |
|---|---|---|---|---|---|
| Drug | ABP-501 | BI 695501 | FKB327 | PF-06410293 | SB5 |
| Disease activity | ≥6 Swollen and ≥6 tender joints†. Acute reactant requirement not available | ≥6 Swollen and ≥6 tender joints. Either ESR of >28 mm/h or CRP>1.0 mg/dL | ≥6 Swollen and ≥6 tender joints CRP≥1.0 mg/dL | ≥6 Swollen and ≥6 tender joints hs-CRP≥0.8 mg/dL | ≥6 Swollen and ≥6 tender joints Either ESR≥28 mm/h or CRP≥1.0 mg/dL |
| Previous biological therapy | Permitted (<2 agents) | Permitted (<2 agents) | Permitted (<2 agents) | Not permitted‡ | Not permitted |
| MTX treatment | Required Stable dose of 7.5–25 mg/week | Required Stable dose of 15–25 mg/week§ | Required Stable dose of 10–25 mg/week | Required Dose range not available | Required Stable dose of 10–25 mg/week |
| Transition design¶ | At week 26, single-arm OLE with ABP-501 | Transition from Humira to either Humira or BI695501 after week 24 | Transition after week 24 in separate OLE with two arms, including Humira and FKB327. After week 52, all patients receive open-label FKB327 | At week 26, Humira arm rerandomised to either Humira or PF-06410293. At week 52, all patients receive open-label PF-06410293** | Transition from Humira to either SB5 or Humira after week 24 |
| Primary end point | ACR20 at week 24 | Coprimary: ACR20 at week 24 and at week 12 | ACR20 at week 24 | ACR20 at week 12 | ACR20 at week 24 |
*Unless specified otherwise, study design information is summarised on the basis of information from the clinicaltrial.gov or EU clinical trial registry (see table 1 for NCT or EudraCT number), searched on 8 September 2015. All studies included in table 2 have an equivalence design.
†From the 66/68 count system.
‡No more than two doses of one biological therapy (other than adalimumab or a lymphocyte depleting therapy).
§Dose may be as low as 10 mg per week if the patient is unable to tolerate a higher dose.
¶Transition from the branded to the biosimilar product within the main study or in the OLE study.
**Study design information from the Peru clinical trial registry, based on a search of biosimilar adalimumab in Citeline's Trialtrove database on 8 September 2015.
ACR20, 20% improvement in the American College of Rheumatology criteria; CRP, C reactive protein; ESR, erythrocyte sedimentation rate; EU, European Union; hs-CRP, high-sensitivity CRP; MTX, methotrexate; OLE, open-label extension.