THU0179 PATIENT AND THEIR ILLNESS – ATYPICAL SOURCES OF THERAPY RISKS. CHARACTERISTICS OF THE USE OF METHOTREXATE (MTX) AND FOLIC ACID (FA) SUPPLEMENTATION IN THERAPY LASTING MINIMUM 8 WEEKS IN ADULT PATIENTSWITH RHEUMATOID ARTHRITIS (RA)

Background MTX is a well-established treatment with an anchor role in RA (1). Patients being treated for RA must pay attention to the specific dosage of drugs and the different routes of administration. Additionally they suffer from the inconvenience related to the progression of the disease. Objectives We observed patients diagnosed with RA, who were treated with subcutaneous (SC) MTX and possible risks associated with this therapy. The attention paid to the inconvenience for the patient associated with SC form of drug administration and the principles of MTX dosing with FA supplementation. Methods 32 rheumatologists were invited to non-interventional, post marketing observation. They collected information from 690 patients who already received a minimum of 1 dose of MTX SC. As part of a standard medical visit, the sociographic data of the patient and information obtained during the medical interview as well as subjective and objective examination were recorded in the prepared form. Data was collected on a weekly basis over a period of 8 weeks. The protocol was compliant with the regulatory and ethical requirements in the country. Results Out of 682 enrolled patients, 581 (85.2%) were sero-positive and 95 (14%) were sero-negative. The average level of anti-CCP antibodies before enrollment was 85.76 Units. The mean time from the diagnosis of the underlying disease was 28.7 months. The vast majority of patients confirmed that they had previously used FA supplementation (92.2%), only 10 patients showed DAS28 at the remission level. During each visit no adverse events (AE) were reported in over 90% of patients. The most commonly reported AE are nausea or weakness. No severe, live threatening AE were recorded. Patients evaluated the pain of the injection on a scale of 1 to 10, where 1 is the minimum and 10 the maximum pain. Most patients assessed the pain of injections as the minimum (1) (56.5% - week 1 (W1), 52.9% - W2, 56.7% - W3, 61.5% - W4, 56.7% - W5, 53.8% - W6, 65.2% - W7, 61.8% - W8). The second most frequently mentioned pain assessment by respondents was 2 (34.6% - W1, 35.3% - W2, 34.3% - W3, 29.2% - W4, 34.3% - W5, 38.5% - W6, 26.1% - W7, 32.9% - W8). No patients reported values between 6 and 10. Patients also assessed how the pain at the site of injection on a scale of 1 to 10, where 1 is the minimum and 10 the maximum pain. Each week, more than half of the patients assessed pain at the injection site as 1 (55.9% - W1, 56.7% - W2, 56.7% - W3, 57.8% - W4, 50.8% - W5, 62.5% - W6, 60.3% - W7, 61.6% - W8). Patients did not report any value of 5-10. More than seven out of ten patients reported FA administration the day 2 of their therapy (76.5%, at W1). In remaining days FA supportive therapy reported 30.3-52.3% of patients (2). Conclusion Neither pain related with injection nor local AE was reported as a significant issue by patients. Adherence to FA administration recommendation is low. This should be evaluated in further studies, but there is a risk that inappropriate FA administration may reduce efficacy of MTX treatment. Reference [1] Smolen JS, et al. Ann Rheum Dis 2017;0:1–18; 2. Todoerti M,et al., Reumatismo. 2013Dec18;65(5):207-18. Disclosure of Interests Piotr Ligocki Consultant for: Accord Healthcare, Grzegorz Orlik Employee of: Accord Healthcare, Vishal Vekariya Employee of: Intas Pharmaceuticals