Do rheumatoid arthritis patients in clinical practice benefit from switching from infliximab to a second tumor necrosis factor alpha inhibitor?

Elisabeth Hjardem ¹, Mikkel stergaard ², Jan Pødenphant ³, Ulrik Tarp ⁴, Lis Smedegaard Andersen ⁵, Jette Bing ⁶, Elisabeth Peen ⁷, Hanne Merete Lindegaard ⁸, Vibeke Stevenius Ringsdal ⁹, Anne Rødgaard ¹⁰, Jens Skøt ¹¹, Annette Hansen ¹², Hans Henrik Mogensen ¹³, Janne Unkerskov ¹⁴ and Merete Lund Hetland ^15*

¹ Hvidovre Hospital, Denmark
² The Danish Database for Biological Therapies in Rheumatology (Danbio), Denmark
³ Copenhagen University Hospital at Herlev, Denmark
⁴ University Hospital at Aarhus, Denmark
⁵ Rheumatism Hospital, Gråsten, Denmark
⁶ Copenhagen University Hospital at Frederiksberg, Denmark
⁷ Sydvestjysk Sygehus in Esbjerg, Denmark
⁸ University Hospital at Odense, Denmark
⁹ Aalborg University Hospital, Denmark
¹⁰ University Hosptial in Glostrup, Denmark
¹¹ University Hospital at Gentofte, Denmark
¹² University Hospital of Rigshospitalet, Denmark
¹³ Hørsholm Hospital, Denmark
¹⁴ Institute for Rational Pharmacotherapy, Danish Medicines Agency, Denmark
¹⁵ University Hospital at Hvidovre, Denmark

^* To whom correspondence should be addressed. E-mail: merete.hetland{at}dadlnet.dk.

Accepted 10 March 2007

Abstract

Objective:In rheumatoid arthritis (RA) patients to investigate the efficacy of switching to a second biological drug.

Methods:Since 2000, Danish RA patients (n=1021) receiving biological therapy have been registered in the nationwide DANBIO database. The 1st and 2nd treatment series of patients, who switched therapy before 2005 (n=235), were analysed for reasons for switching, DAS28 score, DAS28 improvement, EULAR response and drug survival. Most patients switched from infliximab to etanercept or adalimumab.

Results:Median survivals for switchers' 1st /2nd treatment were 37/92 weeks (All patients’ 1st treatment: 119 weeks). Reasons for switching were lack of efficacy (LOE) (109 patients), adverse events (AE) (72), other reasons (54). If patients experienced AE to the 1st drug, 15% had AE to the 2nd. Median DAS28 improvements in 1st /2nd treatment at 3 months were: LOE switchers: 1.1/1.6; AE switchers: 1.5/0.8. In LOE switchers, a good/moderate EULAR response was more prevalent during the 2nd treatment course than during the 1st (63% vs. 54%, p=0.02). AE switchers achieved similar EULAR responses to both treatments (59% vs. 50%, p=0.38).

ConclusionLOE switchers had better clinical response to the 2nd treatment. AE switchers responded equally well to both treatments with a low risk of discontinuing the 2nd drug due to AE. Drug survival of the switchers’ 2nd biological therapy was higher than of the 1st, but lower than that of non-switchers. No difference between various sequences of drugs were found. Danish post-marketing data thus support that RA patients may benefit from switching biological therapy.

Keywords: TNF alpha inhibitors, drug efficacy, observational study, rheumatoid arthritis, second biological treatment

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