Assial - Anti Tnf Treatment in Ankylosing Spondylitis: an Observational Cohort Study in Italy

Pfizer152 enrolled

Overview

Observe in real life adherence therapy and time to switch in ankylosing spondylitis patients with predominant assial involvement with 4 anti-TNF.

retrospective and prospective 150

Study Type

OBSERVATIONAL

Enrollment

152

Conditions

Ankylosing Spondylitis

Interventions

no interventionOTHER

in real life of drug,dosage,frequency and duration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: retrospective:12 months at least first anti-TNF therapy prospective: at maximum 6 months observation AS patients with axial involvement Exclusion Criteria: patients in other AS studies involved

Locations (18)

Unita Operativa Semplice di Reumatologia

Catania, CT, Italy

Arcispedale Sant'Anna

Ferrara, Italy, Italy

Outcomes

Primary Outcomes

Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18

First line anti-TNF treatment included adalimumab, etanercept, golimumab and infliximab. In this outcome, percentage of participants who were taking any one of the first line anti-TNF treatment at baseline and maintained the same up to Month 18 without any change in prescription, were reported.

Time frame: Baseline up to Month 18

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18

BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. Utilizing a numerical rating scale (NRS) of 0-10 (0 = no problem to 10 = worst problem) participants answered 6 questions measuring symptoms of AS (spinal pain, fatigue, joint pain or swelling, areas of localized tenderness, morning stiffness duration and severity). The BASDAI total score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score was then divided by 5. BASDAI=Q1+Q2+Q3+Q4+\[Q5+Q6/2\]/5. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity.

Time frame: Baseline, Month 18

Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity

Low disease activity was defined as a BASDAI score of less than or equal to (\<=) 2. BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity. In this outcome, percentage of participants with unchanged first line anti-TNF drug (nor dose neither frequency, but drug only) in the state of low disease activity, during the specified time points were reported.

Time frame: Month 12, 18

Secondary Outcomes

Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18

ASQoL was a disease-specific questionnaire that assessed the impact of AS on participant's quality of life (QoL). It consisted of 18 questions to be completed by the participant. Each question was answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). Scores of each individual question was summed to give a total score that ranges from 0 (good QoL) to 18 (poor QoL), where lower scores indicated good quality of life. Data for this outcome was planned to be reported separately for switchers (participants who switched to a second anti-TNF drug during observation period) and non-switchers (participants who did not switched to a second anti-TNF drug during observation period).

Data from ClinicalTrials.gov

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