In addition, patients self-rated their overall improvement using the CGI improvement scale (CGI-I) at 8 weeks, and physicians assessed compliance with antidepressant medication (defined as the patient reporting that they were still taking antidepressant medication at Week 8).
Seventy-three percent of patients and 83% of physicians participating in the study preferred lanthanum carbonate over previous phosphate-binder medication at week 12, with a similar trend at week 16.
The other patient had AEs of proteinuria, leukocyturia, and hematuria (considered unlikely to be related to the study medication); at week 52, hemoglobin/hematocrit measurements were no longer outside the predefined limits.
Patients were also assessed for asthma exacerbations (at weeks 2, 6 and 12), completed the AQLQ [ 18] (at weeks 0 and 12) and performed an assessment of their study medication at week 12 (5-point scale ranging from very poor to very good).
Current pain medications reported at week 24 included ibuprofen (45%), acetaminophen (32%), naproxen (20%), triptans (18%), hydrocodone (13%), aspirin (11%), and oxycodone (10%).
For 2-h postmeal glucose (PMG) assessment, a standard meal tolerance test was administered at baseline (prior to first dose of study medication) and at Week 14 (study medication taken 5 min prior to the meal).
Patients who, despite scheduled infusions of double-blind study medication at weeks 8 and 12, did not achieve ≥20% improvement from baseline in SJC and TJC at week 16 were offered escape therapy with open-label TCZ 8 mg/kg.
For patients taking medication for hyperphosphatemia before participating in the study, a product preference questionnaire was completed by patients and physicians to determine preference for lanthanum carbonate or previous medication at weeks 12 and 16 using a 6-item questionnaire for patients and a 7-item question for physicians that addressed various aspects of treatment and overall preference.
Furthermore, there were statistically significant reductions in the frequency of acute headache medication use at week 56; also, of triptan intake favouring OnabotulinumtoxinA versus placebo at week 24 and statistically significant improvements from baseline at week 56[18].
Discontinuation from the study due to medication ADEs at week 52 was similar across all arms, with hyperglycemia and nausea being the most common ADEs.
