Rescue of combination therapy failures using infliximab, while maintaining the combination or monotherapy with methotrexate

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Rescue of combination therapy failures using infliximab, while maintaining

the combination or monotherapy with methotrexate: results of an open trial

G. F. Ferraccioli, R. Assaloni, E. Di Poi, E. Gremese, G. De Marchi and M.

Fabris

Division of Rheumatology, Dipartimento Patologia Medicina Sperimentale e

Clinica, School of Medicine, University of Udine, Italy

Objective. To assess the possible clinical and biological rescue of

rheumatoid arthritis (RA) in 16 patients who were still active despite

intensive combination therapy after receiving infliximab following the

Anti-Tumour necrosis factor Trial in Rheumatoid Arthritis with Concomitant

Therapy (ATTRACT) schedule.

Methods. Sixteen patients who were still active despite combination therapy

with optimal doses of methotrexate (MTX 15­17.5 mg/week) and cyclosporin A

(CsA 2.5­3.5 mg/day) received infliximab. Ten received their combination

plus infliximab (Combi), and six received infliximab plus MTX alone (Mono).

The follow-up was carried out for 30 weeks in all patients and for 46 weeks

in eight. Efficacy and safety were examined.

Results. At entry, the mean disease activity score (DAS) was 5.6 (all

patients had a DAS >3.7). After therapy, eight of 10 patients in Combi and

four out of six in Mono showed an improvement of >50% in the initial swollen

joint count, yet only one patient reached 50% improvement in the initial DAS

after 30 weeks, and one patient had a DAS <2.4 (low disease activity). Of

the eight patients who reached 46 weeks of follow-up, three showed an

improvement in DAS of 50% and two had a DAS <2.4. When considering the

change over time, the difference between DAS at entry and at week 30 was

statistically significant only in patients receiving MTX plus CsA, while it

was not significant in those receiving MTX only. Two patients developed

recurrent febrile upper respiratory infections in the Combi therapy group,

while two had a single febrile infection in the MTX alone group. Two

patients became strongly anti-cardiolipin positive (IgM >40 MPL) and one

developed a coronary syndrome.

Conclusion. Infliximab can be added incrementally to MTX plus CsA, with

favourable results in terms of efficacy and safety over time in severe

rapidly aggressive and progressive RA. Finally, minor evidence emerged for a

stronger efficacy of the Combi treatment compared with Mono.