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• Re: clinical endpoints in RA RCTs
  Johannes W Jacobs
  Published on: 13 April 2016
• clinical endpoints in RA RCTs
  Maarten Boers
  Published on: 13 April 2016

• Published on: 13 April 2016

  Re: clinical endpoints in RA RCTs

  • Johannes W Jacobs, Rheumatologist
  • Other Contributors:
    • Suzan MM Verstappen, Johannes JW Bijlsma

  Dear Editor,

  We do thank Maarten Boers for his complement. We did not employ the composite indices DAS or DAS28 to report clinical efficacy of the two strategy groups in our study, because we had used joint counts not including shoulder joints, which precludes calculating these indices. In our view, shoulder joints are seldom involved in early rheumatoid arthritis and are in addition difficult to score for swelling....

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  Dear Editor,

  We do thank Maarten Boers for his complement. We did not employ the composite indices DAS or DAS28 to report clinical efficacy of the two strategy groups in our study, because we had used joint counts not including shoulder joints, which precludes calculating these indices. In our view, shoulder joints are seldom involved in early rheumatoid arthritis and are in addition difficult to score for swelling.

  For remission and minimal disease activity, the DAS and DAS28 have been investigated; and were found to underestimate disease activity,(1,2) especially the DAS28.(3) We therefore explained clearly in our report why we used our specific definition of remission. We are aware of ongoing processes to improve the definition and criteria of remission, and perhapswe will be able in the near future to report our present results using that new definition.

  References

  1. Khanna D, Oh M, Furst DE, Ranganath V, Gold RH, Sharp JT, et al. Evaluation of the preliminary definitions of minimal disease activity and remission in an early seropositive rheumatoid arthritis cohort. Arthritis Rheum 2007;57:440-7.

  2. Smolen JS, Aletaha D, Koeller M, Weisman MH, Emery P. New therapies for treatment of rheumatoid arthritis. Lancet 2007.

  3. Landewe R, van der HD, van der LS, Boers M. Twenty-eight-joint counts invalidate the DAS28 remission definition owing to the omission of the lower extremity joints: a comparison with the original DAS remission. Ann Rheum Dis 2006;65:637-41.

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  Conflict of Interest:
  None declared.

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• Published on: 13 April 2016

  clinical endpoints in RA RCTs

  • Maarten Boers, Prof of Clinical epidemiology

  Dear Editor, Verstappen et al are to be congratulated on their 'CAMERA' strategy trial. However, they have chosen not to report the results expressed in the Disease Activity Score (DAS or DAS28). In addition, the international RA core set agreed to in 1992 was not fully applied because physician global assessment was not measured. This is a pity because it precludes calculation of ACR reponse. The lack of both DAS and ACR re...

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  Dear Editor, Verstappen et al are to be congratulated on their 'CAMERA' strategy trial. However, they have chosen not to report the results expressed in the Disease Activity Score (DAS or DAS28). In addition, the international RA core set agreed to in 1992 was not fully applied because physician global assessment was not measured. This is a pity because it precludes calculation of ACR reponse. The lack of both DAS and ACR response in the report hinders comparisons between this and other trials, including systematic reviews, and in my view unnecessarily downgrades the value of this report. Finally, the key finding of substantial remission rates is hard to interpret because the measure of remission chosen is nonstandard and unvalidated. I urge the authors to at least report the DAS/DAS28 results, because they have the data available. They should also report the proportion of patients in DAS-remission or in minimal disease activity state (DAS28 <2.85). Sincerely, Maarten Boers

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  Conflict of Interest:
  None declared.

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