Axial Spondyloarthritis, Fibromyalgia
Conditions
Brief summary
This is a prospective observational national (France) study with 2 visits 3 months apart (baseline and 12 weeks after TNF alpha blockers initiation). The objective of recruitment is 500 SpA patients (diagnosis according to their treating rheumatologist) initiating a TNF alpha blocker. The main objective of the study is to evaluate the impact of a concomitant fibromyalgia on the anti-TNF treatment effect in axial Spondyloarthritis in both anti-TNF naïve and pre-exposed patients.
Detailed description
Background: Diagnosis of SpA in the absence of objective signs of inflammation or structural damage can be challenging, and especially difficult to differentiate from Fibromyalgia. Furthermore, such patients can easily be classified as active and refractory to NSAIDs, and inappropriately receive TNF alpha blockers. Objective: Primary objective: To evaluate the impact of fibromyalgia in the TNF alpha treatment effect in axial Spondyloarthritis in both anti-TNF naïve and - experienced patients. Methods: Design: Prospective observational national (France) study with 2 visits 3 months apart (baseline and 12 weeks after TNF alpha blockers initiation). Patients: 500 SpA patients (diagnosis according to their treating rheumatologist) initiating a TNF alpha blocker. Data collection: items permitting the calculation of the ASAS criteria, the FIRST questionnaire (Fibromyalgia Rapid Screen Test), patients and disease characteristics, disease activity and severity items, and the domain leading the doctor's decision for initiating the TNF alpha blocker (CRP/Imaging/Symptoms) will be collected at baseline. Effectiveness measures (e.g. BASDAI and patient's global) and the doctor's decision to continue/discontinue the TNF alpha blocker will be collected during the second visit. Statistical analysis: for the main objective, evaluation of the predictive factors of a TNF alpha response in real life, and the impact of Fibromyalgia in such response (e.g. logistic regression to estimate BASDAI reduction of 50%). For the secondary objectives: evaluation of the relative attributable risks of the doctor's domains leading the TNF alpha blocker initiation (Imaging/CRP/Symptoms) in order to explain the anti-TNF therapy response; evaluation of the concordance existing between the current recommendations and the daily practice. Expected results: A positive finding might results into a change in the way of managing patients (e.g. carefully checking for the co-existence of fibromyalgia before confirming a spondyloarthritis diagnosis, an active disease and also before initiating a specific therapy such as biologics.
Interventions
OTHERFollow-up after 12 weeks after TNF alpha blockers initiation
Sponsors
RCTs
Association de Recherche Clinique en Rhumatologie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged \> 18 years old and suffering from SpA based on the opinion of the treating rheumatologist * Patients in whom the decision of initiating of switching an anti-TNF because of an axial involvement of SpA has been made by the treating rheumatologist. In case of previous exposure to antiTNF a washout period of at least 4 weeks be asked.
Exclusion criteria
* Patients unable to understand the questionnaire * Patients not giving their informed written consent * Patients with absolute contraindications to anti-TNF as per label
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Presence of Fibromyalgia (Defined by a FIRST Questionnaire >= 5/6) as a Predisposing Factor for Lower Treatment Response Rates to TNF Alpha Blockers | At 12 weeks after TNF alpha blockers initiation | The difference in BASDAI50 response at week 12 between the patients with and those without fibromyalgia. |
Secondary
| Measure | Time frame |
|---|---|
| The Relative Attributable Risks of the Doctor's Reported Outcomes Versus the Patients Reported Outcomes in the Decision to Initiate/Switch Anti-TNF Therapy | At 12 weeks after TNF alpha blockers initiation |
| Pourcentage of Patients With Fibromyalgia (as Co-morbidity or as Single Disease) | At 12 weeks after TNF alpha blockers initiation |
| Evaluation of the Concordance Existing Between the Current Recommendations for the Initiation of Anti-TNF in Non-radiographic Axial SpA and the Daily Practice as Represented by This Study. | At baseline and at 12 weeks after TNF alpha blockers initiation |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fibromyalgia Patients According to the FiRST Questionnaire
Follow-up after 12 weeks after TNF alpha blockers initiation | 202 |
| Not Fibromyalgia Patients According to the FiRST Questionnaire
Follow-up after 12 weeks after TNF alpha blockers initiation | 324 |
| Total | 526 |
Baseline characteristics
| Characteristic | Total | Fibromyalgia Patients | Not Fibromyalgia Patients |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 526 Participants | 202 Participants | 324 Participants |
| Age, Continuous | 41.3 years STANDARD_DEVIATION 11.6 | 41.6 years STANDARD_DEVIATION 10.7 | 41.1 years STANDARD_DEVIATION 12.1 |
| Sex: Female, Male Female | 245 Participants | 111 Participants | 134 Participants |
| Sex: Female, Male Male | 281 Participants | 91 Participants | 190 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 202 | 0 / 324 |
| serious Total, serious adverse events | 0 / 202 | 0 / 324 |
Outcome results
Primary
To Evaluate the Presence of Fibromyalgia (Defined by a FIRST Questionnaire >= 5/6) as a Predisposing Factor for Lower Treatment Response Rates to TNF Alpha Blockers
The difference in BASDAI50 response at week 12 between the patients with and those without fibromyalgia.
Time frame: At 12 weeks after TNF alpha blockers initiation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fibromyalgia Patients | To Evaluate the Presence of Fibromyalgia (Defined by a FIRST Questionnaire >= 5/6) as a Predisposing Factor for Lower Treatment Response Rates to TNF Alpha Blockers | 87 participants |
| Not Fibromyalgia Patients | To Evaluate the Presence of Fibromyalgia (Defined by a FIRST Questionnaire >= 5/6) as a Predisposing Factor for Lower Treatment Response Rates to TNF Alpha Blockers | 171 participants |
Secondary
Evaluation of the Concordance Existing Between the Current Recommendations for the Initiation of Anti-TNF in Non-radiographic Axial SpA and the Daily Practice as Represented by This Study.
Time frame: At baseline and at 12 weeks after TNF alpha blockers initiation
Secondary
Pourcentage of Patients With Fibromyalgia (as Co-morbidity or as Single Disease)
Time frame: At 12 weeks after TNF alpha blockers initiation
Secondary
The Relative Attributable Risks of the Doctor's Reported Outcomes Versus the Patients Reported Outcomes in the Decision to Initiate/Switch Anti-TNF Therapy
Time frame: At 12 weeks after TNF alpha blockers initiation