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calculated using the following formula: DAS28-CRP = 0.56 × 1999, Pincus and Stein raise a very important subject: the
sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36 × ln(CRP+1) + 0.014 American College of Rheumatology 20% improvement
× GH + 0.96. criteria (ACR 20) are clinically as well as statistically
Based on the DAS28 score, patients can be categorized significant. 24
into four groups. The DAS28 is based on a count of 28 Most clinical studies on RA have included clinical
swollen and tender joints, with a score ranging from 0 to 9.4, outcomes, such as the ACR definition of improvement, the
4 and can be used to objectively evaluate a patient’s response DAS, and disease-specific QoL, such as health assessment
to treatment. An absolute level of disease activity can be questionnaire disability index (HAQ-DI). 25
selected as a clinically meaningful goal for therapeutic Serum levels of various cytokines. Bradykinin, CXC
intervention; with a value of 3.2 defined as the threshold for chemokine ligand-16 [CXCL16], serotonin, prostaglandin
a low disease activity state and 2.6 as the threshold for (PG) E2, chemokine ligand (CCL) 3, and heat shock protein
remission; DAS28 value > 3.2 and ≤ 5.1 is moderate disease (HSP) 70) were measured in duplicate using a quantitative-
activity; and DAS28 value > 5.1 is high disease activity. sandwich, enzyme-linked immunosorbent assay (ELISA)
According to the 2012 ACR RA Guidelines refers to the according to manufacturer’s instructions (Abcam
ACR RA Disease Activity Measure Recommendations, DAS28 Incorporated, Cambridge, MA, USA).
has been validated in RA. The table from this literature reveals The changes in the levels of cytokine CXCL16 and
that Tender-joint count, Swollen-joint count, ESR, CRP, and serotonin in the participants were examined before and after
the VAS assesses patients’ pain all belong to the RA disease LCAP therapy. The research team also compared changes
activity measures recommended for point-of-care clinical use. between the clinical symptoms and the inflammatory-factor
HAQ-DI. The Health Assessment Questionnaire (HAQ) levels in the serum at the same points to further understand
is another method to assess therapy effectiveness, and is the mechanism underlying the effects of LCAP treatment.
being used increasingly. HAQ was created in 1980 by Fries et
al. The name of the literature is Measurement of patient Statistical Analysis
22
outcome in arthritis which was published on the Arthritis Changes within each group were analyzed using the
Rheum in 1980. The Health assessment questionnaire Wilcoxon signed-rank test for non-normally distributed or
disability index (HAQ-DI) is a questionnaire for the ordinal data and the paired t test for normally distributed
assessment of Rheumatoid Arthritis. The questionnaire is a continuous data. The Mann-Whitney test for non-normally
patient reported outcome (PRO) which is usually distributed or ordinal data and unpaired t test (Student’s
self-administered by the patient. t test or Welch’s t test, according to the variance) for normally
The following categories are assessed by the HAQ-DI: distributed continuous values was used to compare the LCAP
(1) dressing and grooming, (2) arising; (3) eating; (4) and control groups. The partial correlation coefficient was
walking; (5) hygiene; (6) reach; (7) grip; (8) common daily used to examine the correlation between 2 variables, and
activities. The patients report the amount of difficulty they deviation was examined using Fisher’s Z exchange. P values
have in performing some of these activities. Each question of less than .05 were considered significant.
asks on a scale ranging from 0 to 3 if the categories can be
performed without any difficulty (scale 0) up to cannot be RESULTS
done at all (scale 3). At 4 weeks after the intervention group received its last
The HAQ-DI is copyrighted only so that it will be used therapy session, the LCAP showed significantly better clinical
unmodified. This ensures the validity of the measured results. efficacy than the control treatment, P < .05 (Table 2).
However the HAQ-DI is considered to be public domain and At 4 weeks, 11 participants (55%) in the LCAP group
can usually be used without any charge. Most clinical studies achieved the 20% improvement criteria (ACR20), 6 patients
on RA have included clinical outcomes, such as the ACR (30%) the 50% improvement criteria (ACR50), and 4 patients
definition of improvement, the DAS, and disease-specific (20%) the 70% improvement criteria (ACR70) compared to
QoL, such as HAQ-DI. 19.4% (ACR20), 3.2% (ACR50) and 0% (ACR70) for
ACR Core Data Set. The ACR core set of outcome participants in the control group (Table 3).
measures for RA is a definition of improvement which has be At 24 weeks, 14 patients in the LCAP group (70%)
used widely in RA trials. achieved an ACR20, 10 (50%) an ACR50, and 6 (30%) an
The following definition of improvement was selected: ACR70, which scores were significantly higher compared to
20% improvement in tender and swollen joint counts and those of patients in the control group, 25.8%, 12.9%, and
20% improvement in 3 of the 5 remaining ACR core set 3.2% for ACR20, ACR50, and ACR70, respectively (Table 3).
measures: patient and physician global assessments, pain, The number of patients who achieved ACR20, 50, and 70 at
disability, and an acute-phase reactant. Additional validation both 4 weeks and 24 weeks in LCAP group were significantly
of this definition was carried out in a comparative trial, and higher than those in the control group.
the results suggest that the definition is statistically powerful Serum CXCL16 and serotonin levels decreased
and does not identify a large percentage of placebo-treated significantly after LCAP therapy. Serum cytokine levels for
patients as being improved. In their article published in the control and LCAP groups at baseline did not show any
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Huang—Leukocytapheresis Therapy for Rheumatoid Arthritis ALTERNATIVE THERAPIES, JUL/AUG 2020 VOL. 26 NO. 4 39