Presentation: Leflunomide is an acceptable Combination Partner for TNF Inhibitors if Methotrexate is not Tolerated - Results from the German Biologics Register (2007)

342 Leflunomide is an acceptable Combination Partner for TNF Inhibitors if Methotrexate is not Tolerated - Results from the German Biologics Register

Purpose: To investigate therapy continuation and reasons for treatment termination over 30 months in a large cohort of patients treated with Etanercept (ETA), Adalimumab (ADA) or Infliximab (INF).
Methods: Patients with rheumatoid arthritis (RA) who were enrolled in the German biologics register RABBIT at start of treatment with ETA (n=1,068), ADA (n=1,179) or INF (n=497) were followed-up at 3, 6, 12, 18, 24 and 30 months. Treatment termination was defined as stop of the initial biologic agent.
Results: Treatment continuation at 12 months was 65.5%, 62.0% and 54.7% in pts. treated with ETA, ADA or INF, respectively. For patients treated with ETA or INF continuation was generally higher when the TNF inhibitor was combined with methotrexate (MTX) or Leflunomide (LEF) compared to monotherapy (see table 1). This was not the case for ADA. For ETA, ADA or INF no significant differences between MTX and LEF as combination partners were observed. The lower treatment continuation for monotherapy was attributable to inefficacy. There was no difference concerning termination because of adverse events between mono- and combination therapy with MTX or LEF.
After treatment termination with one biologic, more than half of all patients received another biologic agent within three months. After 6 months (12 months) 63% (72%) of the patients treated initially with ETA, 56% (65%) of those treated with ADA and 67% (76%) of those treated with INF were on another biologic agent. Change to another biologic was more frequent after termination because of inefficacy.
Conclusion: Combination of ETA or INF with either MTX or LEF increases the treatment duration, mainly because of higher efficacy. There is no increase in termination due to adverse events with combination therapy. If MTX is not tolerated, combination with LEF seems to be an acceptable alternative.
Percent of patients on the initial anti-TNF therapy
Percent of patients on the initial anti-TNF therapy
n12 months24 months30 monthsp (versus monotherapy)
ETA mono50461.850.147.7
ETA + MTX42971.360.157.50.004
ETA + LEF13569.257.149.90.112
ADA mono50361.355.349.7
ADA + MTX51765.555.550.00.38
ADA + LEF15957.549.241.40.40
INF mono7238.025.823.4
INF + MTX35059.546.343.20.002
INF + LEF7555.535.632.60.19

 A. Zink, None; A. Strangfeld, None; P. Herzer, None; C. Bungartz, None; U. von Hinueber, None; S. Wassenberg, None; J. Listing, None.