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From: Long-Term Outcomes of Patients With Recent-Onset Rheumatoid Arthritis After 10 Years of Tight
Controlled TreatmentA Randomized Trial
Ann Intern Med. 2016;164(8):523-531. doi:10.7326/M15-0919
Figure Legend:
Flow diagram of treatment steps per strategy.
The figure shows the required treatment intensification steps for each strategy as long as the DAS remained >2.4 when measured every 3 mo. In all 4 strategies, patients may progress from one treatment step to the next
at different times, depending on individual DAS results determined at observation every 3 mo. Patients receiving infliximab (who receive their dose every 8 wk) had additional DAS measurements 1 wk before each
infusion. These measurements dictated if the next dose needed to be increased. Doses started at 3 mg/kg of body weight. If the DAS was greater than 2.4, the dose was increased in a stepwise manner to 6 mg/kg, then 7.5
mg/kg, and finally 10 mg/kg (always rounded to the nearest hundredth). The dosage could be tapered if DAS calculations determined every 3 mo were 2.4 or less for at least 6 mo consecutively. Medication dosages were
as follows: azathioprine, 2 mg/kg to 3 mg/kg per day; cyclosporine A, 2.5 mg/kg per day; methylprednisolone, 3 doses of 120 mg in weeks 1, 4, and 8; gold, 50 mg/wk; hydroxychloroquine, 200 mg/d; infliximab, dose as
indicated every 8 wk; leflunomide, 20 mg/d; methotrexate, dose as indicated every week; prednisone, 7.5 mg/d unless indicated otherwise; sulfasalazine, 2000 mg/d. DAS = disease activity score.
Date of download: 5/11/2017
Copyright © American College of Physicians. All rights reserved.
From: Long-Term Outcomes of Patients With Recent-Onset Rheumatoid Arthritis After 10 Years of Tight
Controlled TreatmentA Randomized Trial
Ann Intern Med. 2016;164(8):523-531. doi:10.7326/M15-0919
Figure Legend:
Study flow diagram.
GEE = generalized estimating equation; MI = multiple imputation.
Date of download: 5/11/2017
Copyright © American College of Physicians. All rights reserved.
From: Long-Term Outcomes of Patients With Recent-Onset Rheumatoid Arthritis After 10 Years of Tight
Controlled TreatmentA Randomized Trial
Ann Intern Med. 2016;164(8):523-531. doi:10.7326/M15-0919
Figure Legend:
Patient disposition over time, by strategy.
Graphs depict observed data, showing the percentage of patients included but not the total number of patients with data available at that time point. The LDA group consists of all patients with a DAS of 2.4 or less
(including those in remission). The remission group consists of all patients with a DAS of 1.6 or less (including those in drug-free remission). DAS = disease activity score; LDA = low disease activity. A. Sequential
monotherapy. B. Step-up combination therapy. C. Initial combination therapy with prednisone. D. Initial combination therapy with infliximab.
Date of download: 5/11/2017
Copyright © American College of Physicians. All rights reserved.
From: Long-Term Outcomes of Patients With Recent-Onset Rheumatoid Arthritis After 10 Years of Tight
Controlled TreatmentA Randomized Trial
Ann Intern Med. 2016;164(8):523-531. doi:10.7326/M15-0919
Figure Legend:
Time to response.
Both graphs are based on an imputed data set. Top. Time to first low disease activity (log-rank test, P < 0.001). Bottom. Time to first remission (log-rank test, P = 0.36).
Date of download: 5/11/2017
Copyright © American College of Physicians. All rights reserved.
From: Long-Term Outcomes of Patients With Recent-Onset Rheumatoid Arthritis After 10 Years of Tight
Controlled TreatmentA Randomized Trial
Ann Intern Med. 2016;164(8):523-531. doi:10.7326/M15-0919
Figure Legend:
Patients at various treatment steps over time.
“Outside protocol” denotes patients who did not use medications as dictated in the protocol (Appendix Figure 1). Comparisons of patients still on the initial treatment step at year 10 are as follows: P < 0.001 for strategy 1
vs. 4; P < 0.001 for strategy 2 vs. 4; P = 0.002 for strategy 2 vs. 3; and P = 0.038 for strategy 3 vs. 4. Other comparisons were not significant. Further, 47 patients achieved drug-free remission at year 10 in the following
treatment groups: methotrexate monotherapy, 13 patients (28%) (this was the initial treatment step in strategies 1 and 2); methotrexate and infliximab, 11 patients (23%) (this was the initial treatment step in strategy 4);
methotrexate, sulfasalazine, and prednisone, 8 patients (17%) (this was the initial treatment step in strategy 3); methotrexate with sulfasalazine, 4 patients (9%); sulfasalazine monotherapy, 2 patients (4%); leflunomide
monotherapy, 2 patients (4%); prednisone with methotrexate or cyclosporine A, 2 patients (4%); methotrexate with sulfasalazine and hydroxychloroquine, 1 patient (2%); azathioprine with prednisone, 1 patient (2%); and
outside protocol, 3 patients (6%). DMARD = disease-modifying antirheumatic drug; IFX = infliximab; MTX = methotrexate. A. Sequential monotherapy. B. Step-up combination therapy. C. Initial combination therapy with
prednisone. D. Initial combination therapy with infliximab.
* Patients on the initial treatment step who have tapered their medication dosage to monotherapy or discontinued all medication.
Date of download: 5/11/2017
Copyright © American College of Physicians. All rights reserved.
From: Long-Term Outcomes of Patients With Recent-Onset Rheumatoid Arthritis After 10 Years of Tight
Controlled TreatmentA Randomized Trial
Ann Intern Med. 2016;164(8):523-531. doi:10.7326/M15-0919
Figure Legend:
Drug-free remission, functional ability, and radiographic progression.
The SHS ranges from 0 to 448. HAQ = health assessment questionnaire; SHS = Sharp–van der Heijde score. A. Time to achieve drug-free remission (raw data; log-rank test, P = 0.69). B. Mean functional ability over time
(based on estimates of a linear mixed model). C. Cumulative probability plot of radiographic progression from baseline to year 10 (raw data of completers). Data are ordered from the lowest to highest value per strategy,
and each individual value is plotted with a dot. The changes from baseline were used to find the cumulative probabilities by treatment strategy (39, 40). D. Estimated radiographic damage (determined by weighted
generalized estimating equation) during or after 10 y of targeted treatment, with multiple medication adjustments when low disease activity was not achieved or maintained. The estimated mean SHSs over time for each
strategy, based on the weighted generalized estimating equation, are shown.
Date of download: 5/11/2017
Copyright © American College of Physicians. All rights reserved.
From: Long-Term Outcomes of Patients With Recent-Onset Rheumatoid Arthritis After 10 Years of Tight
Controlled TreatmentA Randomized Trial
Ann Intern Med. 2016;164(8):523-531. doi:10.7326/M15-0919
Figure Legend:
Survival curves per strategy.
The log-rank test yielded a P value of 0.81. Top.Y-axis ranges from 0% to 100%. Bottom. An enlargement of the top graph, with the y-axis ranging from 80% to 100%.
Date of download: 5/11/2017
Copyright © American College of Physicians. All rights reserved.