Dose escalation of Remicade: improvements seen may be explained by a regression-like effect

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Ann Rheum Dis. 2004 Apr;63(4):426-30.

Dose escalation of infliximab in clinical practice: improvements seen

may be explained by a regression-like effect.

van Vollenhoven RF, Brannemark S, Klareskog L.

Department of Rheumatology, Karolinska Hospital, 17176 Stockholm,

Sweden. vanvollenhoven@...

OBJECTIVE: To determine whether increased infliximab doses result in

better clinical outcome in rheumatic diseases. METHODS: Subjects were

124 patients with rheumatoid arthritis treated with biological agents at

a single institute. Index cases were 44 patients whose infliximab doses

had been increased. Controls were patients treated with infliximab

without dose increase (n = 44), and patients treated with etanercept (n

= 36). Disease activity score (DAS28), ACR28 swollen joint counts, and

numerical ACR responses were compared before and after dose increases.

For the controls, the point at which the DAS28 value showed any increase

(despite infliximab/etanercept treatment) was used as the reference time

point. Comparisons were made between three sets of outcomes: best

outcome achieved before the dose increase (cases) or before the

reference time point (controls); outcomes at this point; and best

outcomes after this point. RESULTS: Following dose increase, disease

activity showed modest but statistically significant improvements. The

improvement achieved after dosage escalation was equal to, but not

better than, the best values before dose escalation. While this finding

could be interpreted as " recapturing " the previous response, similar

improvements were seen in both control groups. Thus the same pattern of

worsening and subsequent improvement was seen with or without the

infliximab dose increase.

CONCLUSIONS: Clinical improvement with increased infliximab dose, and

the impression that a previous response can be " recaptured " with higher

doses, cannot be taken at face value, as similar improvements occurred

in two control groups. The use of infliximab at doses higher than 3

mg/kg needs to be evaluated further.

PMID: 15020338

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