Outcome evaluation

• Rheumatologists rely on standardized criteria to assess treatment interventions through measurement of disease activity. The ACR uses criteria for improvement based on percentage improvement in tender and swollen joint count and the presence of at least three or more of the following measures: (a) pain; (b) patient global assessment; (c) physician global assessment; (d) self-assessed physical disability; and

(e) acute-phase reactants. ACR20, ACR50, and ACR70 are common efficacy endpoints in clinical trials. The number corresponds with the percentage improvement. As drug discovery continues to evolve, the acceptable criteria for 20% improvement may be too low. For example, if a patient has 10 tender and swollen joints, reducing that by 20% to 8 tender and swollen joints is, by definition, an improvement by

ACR20 criteria. However, further reduction in symptoms or disease remission may have greater clinical significance and effect on the patient's quality of life.

• Physical disability from RA can be measured through the Stanford HAQ 43,44 This patient self-assessment tool was developed to evaluate patient outcomes in five dimensions of chronic conditions: (a) disability; (b) discomfort; (c) drug adverse effects; (d) dollar costs; and (e) death. Clinicians and clinical studies in rheumatology use HAQ to assess longitudinally changes that influence the patient's quality of life.43,44

• Disease activity can be measured through the Disease Activity Score in 28 joints (DAS 28). Components involved in the calculation are the number of swollen and tender joints, ESR or CRP, and a subjective measure of the patient's general health. A DAS 28 score of 3.2 or less indicates low disease activity, between 3.2 and 5.1 is considered moderate activity, and 5.1 or more is considered to be high activity.18,45 Remission is defined as a DAS 28 score of less than 2.6.

• Before starting treatment for RA, assess the subjective and objective evidence of disease. For joint findings, this includes the number of tender and swollen joints, pain, limitations on use, duration of morning stiffness, and presence of joint erosions. Systemic findings may include fatigue and the presence of extraarticular manifestations. Obtain laboratory measurements of CRP and ESR. The impact of the disease on quality of life and functional status is also important.

• At follow-up visits, compare the patient's status to baseline or previous visits using standardized criteria for improvement of disease activity and the HAQ to assess longitudinally the influence on quality of life.

• Assess the patient's response to initiation of nonbiologic or biologic DMARD therapy after allowing adequate time for the medication to achieve its therapeutic effect.

• Determine whether any adverse reactions associated with each antirheumatic medication are present.

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