iBIOGEAS Registry

Objective

To analyze current evidence on the therapeutic use of biological agents in SAD, based on reports published in indexed international journals included in the PubMed data base.

Coordination

Project Coordinator

Manuel Ramos Casals, Department of Autoimmune Diseases, Hospital Clínic.

Data Management

Pilar Brito Zerón, Sandra Muñoz, Department of Autoimmune Diseases, Hospital Clínic.

Methodology

Diseases included in the study

We analyzed current evidence on the use of biological agents in adult patients with one of the following systemic autoimmune diseases:

1. Systemic lupus erythematosus
2. Sjögren syndrome
3. Systemic sclerosis
4. Polymyosistis
5. Dermatomyositis
6. Polyarteritis nodosa
7. Wegener’s Granulomatosis
8. Churg-Strauss vasculitis
9. Microscopic Polyangiitis
10. Giant cell arteritis
11. Cryoglobulinemia
12. Behçet disease
13. Sarcoidosis
14. Still’s disease
15. Antiphospholipid syndrome
16. Relapsing polychondritis
17. Síndrome antisintetasa
18. Rheumatic Polymyalgia

 

References

A periodic literature search (PubMed) on the use of biological agents in patients with any of the SAD included in the previous list will be made. We will select original articles (not reviews) published in indexed journals that include adults patients (age > 18 years) and contain the minimum information required to evaluate the therapeutic response. Congress “abstracts”, unpublished results (“in press” or “personal communication”) will not be included.

Evidence Level

The evidence level of studies included will be classified in 4 categories according to the study design, using the classification proposed by other international guidelines or recommendations for the use of biological therapies in rheumatologic diseases as a guide.

Categories	Randomization	Control	Design	Follow-up	Type of study
A	Yes	Yes	Experimental	Prospective	Clinical trial
B	No	Yes	Experimental	Prospective	Clinical trial
C	No	No	Observational	Prospective	Open-label study
D	No	No	Observational	Retrospective	Case report

Definition of the therapeutic response

Due to the heterogeneity of the diseases included and to the lack of definitions of the therapeutic response, the response to the biological treatment will be evaluated according to the following definitions:

• Therapeutic response: disappearance of the symptoms motivating the use of biological therapy (complete response) or improvement in one or more of the systemic manifestations of the SAD studied.


• Lack of therapeutic response: no significant improvement after treatment or worsening of the disease.

Definitions of the use of biological therapies

Indications for the use of each biological drug in each of the SAD was categorized in three levels according to the global percentage of response:

• Indicated: drugs with a percentage of response in more than 50% of reported cases.


• Precaution: drugs with a percentage of response between 10% and 50% of reported cases.


• Not recommended: drugs with a percentage of response lower than 10% of reported cases or those drugs reported to produce excess side effects.