A Multi-Center Observational Study on the Use of Biologic Drugs as Monotherapy or Combination With DMARDs in Patients With Rheumatoid Arthritis in Italian Clinical Practice (ARMONIA)

Phase I: Number of Participants With Demographic Characteristics in Monotherapy and Combination Therapy

时间窗: At Baseline (Day of informed consent form signed)

Demographic characteristics were analyzed in participants at Baseline, where Baseline is considered as the study entry visit (day of informed consent form signed). Demographic characteristics which were taken into account included age in years, race, height in centimeters (cm), weight in Kilograms (Kg), and Body Mass Index (BMI) in Kg/cm\^2. Participants with age =\<, \> 59 years, height =\<, \> 163 cm, weight =\<, \> 65.85 Kg and BMI =\<, \> 24.98 Kg/cm\^2 are reported.

Phase I: Number of Participants With Disease Duration in Monotherapy and Combination Therapy

时间窗: At Baseline (Day of informed consent form signed)

The duration of disease is defined as the total time from the diagnosis of rheumatoid arthritis (RA) until the study entry.

Phase I: Number of Participants With Comorbidity in Monotherapy and Combination Therapy

时间窗: At Baseline (Day of informed consent form signed)

Comorbidity is the presence of previous or concomitant diseases.

Phase I: Number of Participants With Autoantibody Status (Rheumatoid Factor and Anti-cyclic Citrullinated Protein Antibodies) in Monotherapy and Combination Therapy

时间窗: At Baseline (Day of informed consent form signed)

The autoantibody included seropositive or seronegative participants for rheumatoid factor (RF) and/or anti-cyclic citrullinated protein antibodies (Anti-CCP). RF value higher than 20 Units (U)/milliliter (mL) is considered seropositive and anti-CCP antibodies value higher than 10 U/mL is considered positive.

Phase I: Number of Participants With Health Assessment Questionnaire- Disability Index in Monotherapy and Combination Therapy

时间窗: At Baseline (Day of informed consent form signed)

The Health Assessment Questionnaire- Disability Index (HAQ-DI) is a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity. Participants assessed their ability to do each task over the past seven days. Participants with scores =\< 0.8625 and \> 0.8625 are reported.

Phase I: Number of Participants With Disease Activity Score 28 in Monotherapy and Combination Therapy

时间窗: At Baseline (Day of informed consent form signed)

The disease activity included Disease Activity Score 28 (DAS28). The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen joint counts (SJC) and tender joint counts (TJC), acute phase response, and general health status. The DAS28 scale ranges from 0 to 10 (0= no disease activity and 10= maximum disease activity; where higher scores represents higher disease activity. The DAS =\< 2.8 indicates clinical remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity. Participants with DAS28 score =\< 2.6 and \> 2.6 are reported.

Phase I: Number of Participants With C-Reactive Protein Value and Erythrocyte Sedimentation Rate in Monotherapy and Combination Therapy

时间窗: At Baseline (Day of informed consent form signed)

The disease activity included biological markers of inflammation: C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR). A reduction in CRP and ESR values indicates improvement. Participants with CRP values =\< 0.28 and \>2.8 milligram/deciliter (mg/dL); and ESR values =\< 11 and \>11 millimeters/hour (mm/hr) are reported.

Phase I: Number of Participants With Clinical Disease Activity Index in Monotherapy and Combination Therapy

时间窗: At Baseline (Day of informed consent form signed)

The disease activity included Clinical Disease Activity Index (CDAI) which is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment; and patient's global assessment (PtGA) and physician's global assessment (PhGA) assessed on 0-10 cm visual analog scale (VAS), where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =\< 2.8 indicates clinical remission, \> 2.8 to 10 indicates low disease activity, \> 10 to 22 indicates moderate disease activity, and \> 22 indicates high disease activity. Participants with CDAI score =\< 7.75 and \> 7.75 are reported.

Phase I: Number of Participants With Simplified Disease Activity Index in Monotherapy and Combination Therapy

时间窗: At Baseline (Day of informed consent form signed)

The disease activity included Simplified Disease Activity Index (SDAI) which is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =\< 3.3 indicates disease remission, \> 3.4 to 11 indicates low disease activity, \> 11 to 26 indicates moderate disease activity, and \> 26 indicates high disease activity. Participants with SDAI score =\< 8.17 and \> 8.17 are reported.

Phase I: Number of Participants With Duration of Combination Therapy Before Monotherapy in Monotherapy and Combination Therapy

时间窗: At Baseline (Day of informed consent form signed)

The duration of combination therapy before monotherapy are reported. The duration was estimated by calculating total duration from starting the combination therapy till the participant switched to monotherapy. Participants who started the combination therapy and later switched to monotherapy =\< 337 days, \> 337 days, =\< 336 days, \> 336 days are reported.

Phase I: Number of Participants Treatment Line in Which Monotherapy Has Been Adopted in Monotherapy

时间窗: At Baseline (Day of informed consent form signed)

The first biologic treatment line was defined as the first use of any biologic drug in treatment of rheumatoid arthritis, regardless its association with DMARDs and the second treatment line as the subsequent use of a different biologic drug. Participants who adopted monotherapy as =\< 2 and \> 2 therapy lines are reported. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.

Phase I: Number of Biologics Administered as Monotherapy in Monotherapy and Combination Therapy

时间窗: At Baseline (Day of informed consent form signed)

Participants who received at least one previous treatment with biologics in monotherapy and no previous monotherapy with biologics are reported.

Phase I: Number of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy

时间窗: At Baseline (Day of informed consent form signed)

Participants who had prevalence with at least one previous switch, swaps, and switch/swap to other therapy are reported.

Phase I: Number of Participants With Reasons Leading to the Use of Biologic in Monotherapy

时间窗: At Baseline (Day of informed consent form signed)

Reasons leading to the use of biologic in monotherapy includes DMARDs intolerance, insufficient therapeutic effect, intolerance to biologic drug, low participant's compliance, concomitant pathologies, pregnancy desire, remission from combination therapy, remission from monotherapy, others and unknown. Participants with reason leading to the use of biologic in monotherapy are presented. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.

Phase II: Percentage of Participants Who Retained on Tocilizumab Monotherapy

时间窗: Up to 18 months

The probabilities of participant to retain on therapy at various time points are reported.

Phase II: Retention Rate in Therapy, Percentage of Participants Achieving DAS 28 ESR <2.6 and <3.2 at Month 18

时间窗: At month 18

Participants who retained the therapy were analyzed for disease activity (DAS28 ESR) at Month 18. The DAS28 ESR is a measure of the participant's disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease.