EValuation of HumIRA® in Patients With Active Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in EASTern European Countries

Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy

HAQ-DI score was calculated using the standard questionnaire covering 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale from 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.

Time frame: Baseline, 4, 7 and 13 months

Participant Acceptability of Self-injection at Month 13 (End of Study)

Participant acceptability of self-injection was assessed by the percentage of participants able to appropriately execute self-injection after initial training in the medical center, per investigator's opinion and documentation of necessity of re-training. Those participants able to self-inject also reported their experience of self-injection as convenient or inconvenient.

Time frame: 13 months

Compliance With the Humira Administration Schedule at Month 13 (End of Study)

Compliance with the Humira therapy was assessed by the number of missed injections among participants. Documentation of injections missed or delayed by more than 7 days was made at each study visit.

Time frame: Month 13

Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy

Tolerability was evaluated by assessing the mean duration (in weeks) of treatment with Humira until the development of an adverse event leading to treatment discontinuation or until early discontinuation for any other reason.

Time frame: From first treatment until study discontinuation, up to 13 months.

Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Tolerability was measured by AEs and SAEs, collected during the course of the study. See the Reported Adverse Event section for details.

Time frame: From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the last dose of physician-prescribed therapy. Mean (standard deviation [SD]) duration of therapy was 49.0 (16.0) weeks.