Background/Purpose: Sustained targeted therapeutic outcome with biological therapy in real clinical conditions is not yet achievable in a large proportion of rheumatoid arthritis (RA) patients. The composite indices assess the activity of RA, but are also influenced by concomitant diseases and conditions.

To identify RA patients on biological therapy without therapeutic success for one year in the conditions of real clinical practice and to evaluate the influence of cardiovascular risk factors.

Methods: A retrospective single-center study included РА patients from UMHAT “St. Marina” – Varna, Bulgaria, on biological therapy. All available medical administrative databases were used.

Clinical and demographic data, the presence of hypertension (HTN), hypercholesterolemia (HCL), diabetes mellitus (DM) and chronic steroid use were analyzed.

RA activity was assessed in each patient three times in twenty months, every six months. SDAI with generally accepted activity thresholds was used. Favorable result was accepted at sustained 12 or 6 months or one-time LDA, unfavorable result – without LDA even once in 12 months.

Descriptive statistics, Chi-square (for qualitative variables), independent T-test (for quantitative variables) and multinomial logistic regression model were used to determine the influence of CVR factors on the twenty-month therapeutic outcome. Significance level for p < 0.05 was used.

Results: Sustained LDA outcomes (6 and 12 months) and LDA at one point were found in 18.9%, 32.6% and 14.7% of patients, respectively.

33.7% of patients did not achieve LDA even once in 12 months.

The same proportion of patients did not achieve LDA even once in IL6i and TNFi (32.9% vs. 34.3%, p > 0.05). Compared to the combination with MTX, monotherapy was associated with significantly more patients who did not achieve LDA even once with TNFi but not with IL6i. (50% vs 24.6%, p = 0.008; 45.5% vs 20.5%, p > 0.05 respectively).

The most common CVR is HTN (58.9%), followed by HCL (57.9%), steroid use (57.4%), smoking (30.5%), obesity (23.2%) and DM (15.3%).

More RA patients with CVR compared those without CVR did not achieve LDA even once in 12 months (smoking 53.4 % vs 25.0% p < 0.001; BMI > 30 kg / m2 50.0% vs 28.8% p = 0.009; HTN 47.3% vs 14.1% p < 0.001; HCL 40.0% vs 25% p = 0.031; DM 72.2% vs 26.7% p < 0.001).

RA patients with DM, HTN or smokers are significantly more likely not to be in the LDA even once for 12 months than to be in a sustained 12-month LDA, regardless of the type of biologic therapy (OR = 10.6 95% CI 2.1-52.2; 6.5, 95% CI 2.5-16.9; 2.5, 95% CI 1.0-6.4, respectively)

Obese RA patients are significantly more likely not to be in the LDA even once for 12 months than to be in a sustained 12-month LDA in TNFi treatment (OR 4.5 95% CI 1.2-18.1), but not in IL6i treatment.

The use of steroids as well as HCL as CVR factors were not combined with a different chance of RA patients for 12-month therapeutic outcome.

Conclusion: More than a third of RA patients do not achieve the therapeutic goal in real life, regardless of biological therapy. The presence of certain CVR factors adversely affects the therapeutic outcome. Choosing the right biological medicine could be a step forward in solving the problem.