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A Novel Method to Combine Assessment of Benefit and Harm: Outcome Measures in Rheumatology 3×3 Methodology Applied to Two Active Comparator Trials
Author(s) -
Boers Maarten,
Singh Jasvinder A.,
Cofield Stacey S.,
Bridges S. Louis,
Moreland Larry W.,
O'Dell James R.,
Wu Hongsheng,
Leatherman Sarah,
Curtis Jeffrey R.
Publication year - 2019
Publication title -
arthritis care and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.032
H-Index - 163
eISSN - 2151-4658
pISSN - 2151-464X
DOI - 10.1002/acr.23590
Subject(s) - medicine , rheumatoid arthritis , rheumatology , adverse effect , clinical trial , randomized controlled trial , harm , physical therapy , political science , law
Objective The Outcome Measures in Rheumatology ( OMERACT ) 3×3 method analyzes the occurrence of benefit and harm simultaneously at the individual patient level. We applied this method to 2 recent rheumatoid arthritis ( RA ) trial data sets. Methods The Treatment of Early Aggressive Rheumatoid Arthritis ( TEAR ) and the Rheumatoid Arthritis Comparison of Active Therapies ( RACAT ) randomized trial outcomes for safety were defined according to OMERACT as having no adverse events ( AE s), non‐serious AE s, and serious AE s. Treatment efficacy was defined as good, moderate, or no response. A good treatment response without any AE s was labeled an unqualified success, and no treatment response but at least 1 AE was considered an unmitigated failure. The association between benefit and harm was assessed by chi‐square or exact tests, as appropriate. Results In TEAR , 612 of 755 patients had response data at 48 weeks: 14% of patients experienced unqualified success and 9% had unmitigated failure, with no difference between the treatment arms. Treatment response and AE rates were not correlated. In RACAT , 309 of 353 patients had response data at 48 weeks: 6% of patients experienced unqualified success and 11% had unmitigated failure, with no differences between the treatment arms. Response and AE rates were negatively correlated. The frequency of AE s and serious AE s increased as response decreased ( P = 0.008). Conclusion We found some evidence that clinical response may be reduced by the co‐occurrence of AE s.