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RESEARCH - Drug-free remission following one year of MTX or placebo in undifferentiated arthritis patients

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Drug-Free Remission after Treatment Discontinuation Following One Year

of Methotrexate or Placebo Treatment in Undifferentiated Arthritis

Patients

Visser, Ronday, van Dongen, van Aken, Lard, Hulsmans, Speyer, Westedt,

Peeters, Toes, Breedveld, Allaart, Huizinga; Leiden, the Netherlands

Jon Giles

Objectives

The " PRObable rheumatoid arthritis: Methotrexate vs. Placebo

Treatment " (PROMPT) study demonstrated that early treatment of

synovitis, even in those without sufficient signs and symptoms for

classification as rheumatoid arthritis, may lead to a delay in

diagnosis and less long-term joint damage. The authors presented

outcomes for the 12 months after discontinuation of methotrexate for

those patients who did not meet classification criteria for RA during

the study.

Methods

The methods of the PROMPT study have been described here previously.

For these analyses, patients who had not progressed to RA at 12 months

had their methotrexate discontinued and were followed for out to a

maximum of 30 months from randomization for flare, at which time

treatment was reintroduced.

Results

110 patients were randomized to receive either methotrexate or

placebo. At 12 months, 39 (71%) of the patients in the methotrexate

group vs. 21 (38%) of the placebo group were able to discontinue

methotrexate. Of those initially randomized, 18 (33%) of the

methotrexate group vs. 17 (31%) of the placebo group were in

sustained, drug-free remission at 12 months. Univariate predictors of

drug-free remission were higher age, shorter duration of symptoms (< 6

months), lack of baseline erosions, and lack of anti-CCP antibodies.

In multivariable models including all of these factors, only lack of

baseline erosions and lack of anti-CCP antibodies were significant

predictors of sustained drug-free remission. Disease activity scores,

either at baseline or change, were not predictive of drug-free

remission in univariate or multivariate models.

Conclusion

Discontinuation of treatment in early undifferentiated arthritis

patients in remission can be discontinued with success in patients

without baseline erosions or anti-CCP antibodies. In patients with

these risk factors, sustained drug-free remission is unlikely.

Editorial Comment

The PROMPT study is unique, and has enlightened the treatment of early

polyarthritis. The most important aspect of this abstract is the high

flare rate in the anti-CCP positive patients with discontinuation of

methotrexate, suggesting that this group of patients deserves

continued treatment, regardless of disease activity measures. Those

without anti-CCP antibodies may still require restarting therapy, but

have a better chance of not requiring therapy. However, early

treatment with methotrexate did not seem to have influenced drug-free

remission rates, as the frequency of drug-free remission was equal in

the methotrexate and placebo groups. This could suggest that the

" window of opportunity " for therapy to alter the course of RA lies

even earlier than the undifferentiated arthritis phase.

s Hopkins Arthritis

http://www.hopkins-arthritis.org/physician-corner/education/eular2008/RA-Clinica\

l-Aspects/abstract-op-0040.html

Not an MD

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