a. ASAS 20 improvement criteria ASAS20 is defned as an improvement of at least 20% and an absolute improvement of at least 1 unit on a 0-10 scale in at least three of the following domains: - patient global (0-10) - patient pain (0-10) - function (assessed by BASFI) - infammation (mean of BASDAI questions 5 and 6) In the remaining domain, there should be no worsening of 20 % and a minimum of 1 unit, on a 0 to 10 scale. ref: Anderson JJ, Baron G, van der Heijde D, Felson DT, Dougados M. Arthritis Rheum. 2001;44:1876–86. b. ASAS 40 improvement criteria ASAS40 is defned as an improvement of at least 40% and an absolute improvement of at least 2 units on a 0-10 scale in at least three of the following domains: - patient global (0-10) - patient pain (0-10) - function (assessed by BASFI) - infammation (mean of BASDAI questions 5 and 6) In the remaining domain, there should be no worsening in the fourth domain. ref: Brandt J, Listing J, Sieper J, Rudwaleit M, et al. Ann Rheum Dis. 2004;63:1438–44. c. ASAS 5/6 improvement criteria The ASAS 5/6 improvement criteria = an improvement of at least 20% in at least fve of these six domains: - patient global (0-10) - patient pain (0-10) - function (assessed by BASFI) - infammation (mean of BASDAI questions 5 and 6) - CRP - spinal mobility (assessed by lateral spinal fexion) ref: Brandt J, Listing J, Sieper J, Rudwaleit M, et al. Ann Rheum Dis. 2004;63:1438–44. d. ASAS partial remission ASAS has defned a state of partial remission, which refects very low disease activity. In order to fulfll an ASAS partial remission state, a value of 2 (on a 0 to 10 scale) or less should be present in each of the following domains: patient global, pain, function (BASFI), and infammation (mean of BASDAI questions 5 and 6). ref: Brandt J, Listing J, Sieper J, Rudwaleit M, et al. Ann Rheum Dis. 2004;63:1438–44. e. BASDAI 50 response Response to a treatment is defned by improvement of at least 50 % in the BASDAI score or an absolute change of 2 units (on a 0 to 10 scale) after 3 months of treatment with TNF- inhibitors, together with an expert opinion compatible with improvement. ref: Braun J, Davis J, Dougados M, Sieper J, et al. Ann Rheum Dis. 2006;65(316–320). f. ASDAS improvement criteria ASAS has also defned ASDAS-based response criteria. According to the ASDAS improvement criteria, a change in the score of at least 1.1 units is equivalent to a “clinically important improvement,” and a change of at least 2.0 units is called a “major improvement” ref: Machado P, Landewé R, Lie E. et al. Ann Rheum Dis. 2011;70(1):47–53. g. ASDAS inactive disease ASAS has defned cutoffs for disease activity states, using the ASDAS score. A value below 1.3 is considered “inactive disease”. ref: Machado P, Landewé R, Lie E. et al. Ann Rheum Dis. 2011;70(1):47–53. • Clinically Important ASDAS ≥1.1 improvement The ASAS Response Criteria Response criteria are intended to measure a response to treatment. The ASAS-defned improvement criteria as well as BASDAI and ASDAS can be used for defning improvement or response in both clinical practice and in studies. • Major ASDAS ≥2.1 improvement 26
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