Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose
In the 48-week, double-blinded, noninferiority RACAT trial, 353 methotrexate suboptimal responders were randomized to two treatment strategies, either the addition of sulfasalazine and hydroxychloroquine (triple therapy) or the addition of etanercept. If subjects showed no clinical improvement in DAS28 at 24 weeks, their treatment strategy was switched. Compliance to the study medications as well as placebo is an important aspect for any clinical outcome and an important consideration for the application of results to treatment of patients. This is particularly relevant since many have questioned the tolerability of triple therapy.
Methods
Compliance with placebo and study medications was calculated using returned pill counts. Participants were defined as medication compliant if they took 80% or more of dispensed study medication. Baseline characteristics were compared between active drug compliant and non-compliant subjects for both the 24-week and 48-week follow-up periods. Administration method (pills versus injection) compliance, treatment strategy (active drug versus placebo) compliance, and the association between compliance and treatment response were also explored.
Results
Within active drug group, there were no significant differences at 24 or 48 weeks between compliant and non-compliant subjects for any of the baseline variables except that the Physician Global Assessment score for compliant was significantly better than that of non-compliant (p=0.01 and p=0.01, respectively). Injection compliance was significantly higher than pill compliance at both 24 weeks (94.6% versus 86.4%, p = 0.0003) and 48 weeks (96.4% versus 90.6%, p = 0.0034). There were no differences in compliance of active and placebo medications at 24 weeks (90.0% versus 90.9%) and 48 weeks (93.9% versus 93.8%). Unlike some other studies, we found no relationship between compliance and treatment response. Other factors previously found to be associated with good compliance, such as demographic variables, treatment assignment, and treatment response, were not significantly related.
Conclusion
Subjects taking pills were less likely to be compliant than those having injections. Patients were equally likely to take active therapy and placebo therapy. Despite differences in compliance, treatment strategies were comparable and both strategies were well tolerated.
Disclosure:
S. Leatherman,
None;
H. Wu,
None;
E. Keystone,
Abbott Laboratories, Amgen Inc., AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb, F. Hoffmann-La Roche Inc, Janssen Inc, Lilly Pharmaceuticals, Novartis Pharmaceuticals, Pfizer Pharmaceuticals, Sanofi-Aventis, UCB,
2,
Abbott Laboratories, AstraZeneca Pharma, Biotest, Bristol-Myers Squibb, Company, F. Hoffmann-La Roche Inc, Genentech Inc, Jannsen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, UCB,
5,
Abbott Laboratories, Astrazeneca LP, Bristol-Myers Squibb Canada,F. Hoffmann-La Roche Inc., Janssen Inc., Pfizer Pharmaceuticals, UCB, Amgen,
8;
M. Brophy,
None;
J. O’Dell,
Abbvie, Lilly, Antares, Medac,
5.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/compliance-in-the-rheumatoid-arthritis-comparison-of-active-therapies-trial-triple-vs-etanercept/