An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Sero-Positive Rheumatoid Arthritis Who Are Non-Responders or Intolerant to a Single TNF-Inhibitor (PORTSMAB)

A tender joint count (TJC) is the most specific clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28. A negative change from baseline indicates improvement.

A swollen joint count (SJC) is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/ not swollen (0) giving a total possible SJC score of 0 to 28. A negative change from baseline indicates improvement.

The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement.

The C-reactive protein is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline indicates improvement.

The Physician's Global Assessment of disease activity was assessed using a 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).Change from Baseline = score at observation minus score at Baseline. An increase in score from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

The Patient's Global Assessment of disease activity was assessed using 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).Change from Baseline = score at observation minus score at Baseline. An increase in score from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

The patient's assessment of pain was performed using a 100 mm VAS ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.

The functional capacity was analyzed using Health Assessment Questionnaire-Disability Index (HAQ-DI). It is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 domains (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each domain are scored from 0 to 3 (0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do). Overall score was computed as sum of domain scores and divided by the number of domains. A total possible score ranged from 0 (best) to 3 (worst).

Adverse event, primary and secondary insufficient responses and monoclonal gammopathy were the reasons for starting rituximab therapy.

There are two patterns of re-treatment, namely treat-to-target and according to the clinic.

Treat-to-target: a new cycle every 6 months if not in remission, with the participant receiving no new course of treatment as long as he is in remission.

On demand (according to clinic): a new cycle when, in an assessment performed at least 16 weeks after the last treatment cycle, the participant shows moderate or high disease activity [DAS28 > 3.2 or difference in DAS28 (ΔDAS28) > 0.6]

An infusion reaction or injection site reaction is an event that occurs after infusion or injection which may include hypersensitivity reactions or anaphylactic reactions.

Follow-up of the infectious events was done after Month 6 visit, Month 12 visit and Month 24 visit.

An Adverse Events (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect