Trial Outcomes & Findings for An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy (NCT NCT01664117)

A total of 210 participants were enrolled from 38 rheumatology units in Spain. This study was conducted between June 2012 and June 2013.

Of 210 participants, one participant was excluded from the study because of past history of biologic disease-modifying antirheumatic drug (bDMARD) monotherapy under 6 months. Therefore, 209 participants were evaluated in this study.

An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy

Level of education completed is a component of socio-demographic characteristics. It is recorded as cannot read, no formal education, primary education or equivalent, general secondary education, vocational education, and higher education or equivalent. Data were collected at study entry (Single visit study)

Smoking habits is a component of socio-demographic characteristics. Participants' smoking status is recorded as non-smoker, smoker, and ex-smoker at Visit 1.

Smoking-habit included number of pack per years is reported.

Smoking-habit included years of smoking/quit smoking is reported for participants.

Onset of rheumatoid arthritis is a component of clinical characteristics.

Family history is a component of clinical characteristics. Participants who had a family history of rheumatoid arthritis is recorded as yes/no. Also, family history related to parents, siblings, aunts and uncles, grandparents, or other is recorded.

Co-morbidity is a component of clinical characteristics It included stroke, heart failure (grades I, II, III or IV), ischemic heart disease, hypertension, dyslipidemia, osteoporosis, interstitial lung disease, chronic obstructive pulmonary disease (COPD), depression, diabetes mellitus, liver disease, serious infections, tuberculosis, hematological malignancies, solid tumors and others. Participants were assessed into categories with associated co-morbidities as yes and no.

Extra-articular manifestations (EAMs) are a component of of clinical characteristics EAMs are symptoms and diseases that occur in parts of the body other than joints. These included the presence of amyloidosis (rare disease that results from the buildup of misfolded proteins), anemia (deficiency of red cells in the blood), heart complications, lung complications, rheumatoid nodules (local swelling), felty's syndrome (presence of rheumatoid arthritis, an enlarged spleen, and an abnormally low white blood cell count), and secondary Sjogren's (an autoimmune disorder that damages moisture-producing glands, making it difficult to produce saliva and tears). Participants were assessed into categories with extra-articular Manifestations as yes, no and missing nos.

Participants were assessed for painful and swollen joints at Visit 1. Painful joint is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue.

The Physician's global assessment of disease activity is assessed using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).

Patient global assessment of disease activity visual analog scale is assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).

Hematology parameters are considered as one of the component of clinical characteristics. Hematology parameters included white blood cells (WBC), platelets, red blood cells (RBC), hemoglobin, hematocrit, neutrophils, basophils, eosinophils, lymphocytes, monocytes.

Biochemistry parameters is considered as one of the component of clinical characteristics. Biochemistry parameters included alanine amino transferase (ALT), aspartate amino transferase (AST), triglycerides, total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and total lipids.

Rheumatoid Factor (RF) is the auto antibody directed against Immunoglobulin G and its concentration is observed in human serum or plasma. Anti-Cyclic Citrullinated Protein Antibodies (Anti-CCP) antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.

The test for C-reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Erythrocyte sedimentation rate (ESR) is a laboratory test that provides a non-specific measure of inflammation. A higher rate is consistent with inflammation.

Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as "no pain" and the right-hand extreme equals 10 as "unbearable pain"

Number of participants with joint damage is recorded as yes and no.

Disease activity score (DAS) 28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening.

DAS28 is divided into 4 categories as: remission \<2.6, low activity 2.6-3.2, moderate 3.2-5.1 and high \>5.1.

Clinical disease activity index (CDAI) of participants is a composite index that is calculated as the sum of number of painful joint, number of swollen joint, patient's VAS (0-10 cm) assessment, physician global VAS assessment (0-10 cm). The CDAI score ranges from 0 to 76, where lower scores indicate less disease activity.

CDAI is divided into 4 categories as: remission \<2.8, low activity 2.8-10, moderate 10-22 and high\>22.

Simple Disease Activity Index (SDAI) is calculated by sum of number of painful joint and swollen joint count, patient and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligrams per deciliter (mg/dL). SDAI total score ranges from 0 to 86, where higher scores indicates greater affect due to disease activity.

SDAI is divided into 4 categories as: remission (\<3.3), low activity (3.3-11), moderate activity (11-26) and high activity (\>26).

Number of participants prescribed with first synthetic disease-modifying antirheumatic drug therapy (sDMARD) in monotherapy and in a combination before the study was presented.

Mean time in months at Visit 1 between diagnosis and prescription of first sDMARD/ first bDMARD was presented.

Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, chloroquine, leflunomide, ciclosporin, methotrexate, and chlorambucil medications.

Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, leflunomide, ciclosporin, methotrexate, and leflunomide + methotrexate.

Number of participants prescribed first bDMARD before the study was presented.

Number of participant who received bDMARD (etanercept, infliximab, golimumab, adalimumab, abatacept, tocilizumab, rituximab) before the study was reported in at Visit 1.

Mean time between the last sDMARD and bDMARD received at Visit 1 was presented in months.

Any reasons for changing the previous sDMARD/bDMARD treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other. There may be more than one reason for changing sDMARD/ bDMARD per participant.

Number of sDMARD and bDMARDs received by Participants before the study was presented

The reasons for changing the previous sDMARD, sDMARD+ bDMARD or bDMARD treatment and starting the study treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement, and other.

Median time in months taking the Biologic Agent in monotherapy before the study was presented.

Participants received concomitant medications (corticosteroids, non-steroidal anti-inflammatory drugs \[NSAID\], and other treatment) before the study were presented.

Current bDMARD treatment included etanercept, infliximab, adalimumab, abatacept, tocilizumab, rituximab and certolizumab.

Other treatments included corticosteroids, NSAIDs and corticosteroid + NSAID.

The reasons for changing current biologic treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other.

Participants who received tocilizumab, Anti-tumour necrosis factor (TNF) and Other treatment of monotherapy were reported.

Mean score of DAS28 index, CDAI index, and SDAI index were recorded for participants who received biologic agent in monotherapy at the time of the study.

Mean score of categorization (remission/low activity and moderate/high activity) of DAS28 index, CDAI index, and SDAI index was recorded for participants who received biologic agent in monotherapy at the time of the study .

Participants who received biologic agent in monotherapy at the time of the study were assessed for a number of painful joints (NPJ) and swollen joints (NSJ).

Participants who received biologic agent in monotherapy at the time of the study were assessed for C-reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR).

An Adverse Event was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Adverse events were collected as a reason for the change to monotherapy.

An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.