Table 2:
Adverse Events Before and During the Treat to Target Intervention
| Before intervention | During intervention | P-value ǂ | Difference (95% CI) | ||
|---|---|---|---|---|---|
| Any adverse event* | |||||
| Percent of visits | 10.2% | 8.8% | 0.41 | −1.4% (−3.7,1.0%) | |
| Percent of patients | 29.6% | 25.7% | 0.45 | −3.9% (−10.8, 3.1%) | |
| Number per patient, mean | 0.43 | 0.35 | 0.18 | −0.1% (−0.2, 0.1%) | |
| Abnormal liver function tests | |||||
| Percent of visits | 0.8% | 0.3% | 0.12 | −0.5% (−1.1, 0.1%) | |
| Percent of patients | 2.8% | 1.0% | 0.11 | −1.8% (−4.0, 0.3%) | |
| Number per patient, mean | 0.03 | 0.01 | 0.08 | −0.02% (−0.1, 0.1%) | |
| Rash/oral ulcers/alopecia | |||||
| Percent of visits | 1.7% | 0.8% | 0.07 | −0.9% (−1.7, 0.1%) | |
| Percent of patients | 5.9% | 2.9% | 0.07 | −3.0% (−6.2, 0.1%) | |
| Number per patient, mean | 0.07 | 0.03 | 0.04 | −0.04% (−0.1, 0.00%) | |
| Infections | |||||
| Percent of visits | 2.7% | 3.8% | 0.07 | 1.1% (−0.3, 2.6%) | |
| Percent of patients | 9.4% | 12.1% | 0.18 | 2.7% (−2.1, 7.5%) | |
| Number per patient, mean | 0.11 | 0.14 | 0.13 | 0.03% (0.0, 0.1%) | |
| Gastrointestinal symptoms | |||||
| Percent of visits | 2.2% | 2.2% | 0.79 | 0.0% (−1.2, 1.2%) | |
| Percent of patients | 6.5% | 7.9% | 0.37 | 1.4% (−2.6, 5.4%) | |
| Number per patient, mean | 0.09 | 0.08 | 0.96 | 0.01% (−0.1, 0.1%) | |
| Rheumatology visits | |||||
| Number per patient, mean (± SD) | 4.0 (1.4) | 3.6 (1.2) | 0.02 | −0.4 (−0.6, −0.2) | |
| Biologic DMARDs used | |||||
| Percent of visits | 46.5% | 42.5% | 0.76 | −3.9% (−7.9, 0.0%) | |
| Percent of patients | 53.6% | 49.8% | 0.73 | −3.7% (−11.5, 4.0%) | |
| Monitoring laboratory tests¶ | |||||
| Percent of patients | 90.0% | 52.7% | <0.001 | −37% (−44, −31%) | |
| Number per patient, mean (± SD) | 10.6 (6.3) | 5.1 (6.3) | <0.001 | −5.5 (−6.5, −4.5) | |
| Diagnostic imaging¶ | |||||
| Percent of visits | 15.4% | 8.9% | 0.005 | −6.5% (−9.7, −3.2%) | |
| Percent of patients | 38.6% | 12.4% | <0.001 | −26% (−33, −20%) | |
| Number per patient, mean (± SD) | 1.0 (2.0) | 0.3 (1.3) | <0.001 | −0.7 (−1.0, −0.4) | |
Adverse events included rashes, oral ulcers, alopecia, infections requiring antibiotics, liver toxicity as manifest by abnormal liver function tests and/or abnormal liver imaging, cytopenias as manifest by complete blood counts below the lower limits of normal, renal insufficiency defined as a 50% decrease in creatinine clearance, cancer, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, unexplained weight loss/gain, abdominal pain or dyspepsia).
P-values from generalized linear mixed models adjusting for site effect, and within provider clustering.
Monitoring laboratory tests included complete blood count, liver function tests, serum creatinine, and acute phase reactants. Diagnostic imaging included DXA, plain radiographs, computed tomography (CT) scans, and magnetic resonance imaging. We did not calculate the percent of visits with laboratory tests because many tests took place between visits.