Tuberculosis and other opportunistic infections in tofacitinib-treated patients with rheumatoid arthritis.
Ann Rheum Dis
; 75(6): 1133-8, 2016 Jun.
Article
en En
| MEDLINE
| ID: mdl-26318385
ABSTRACT
OBJECTIVES:
To evaluate the risk of opportunistic infections (OIs) in patients with rheumatoid arthritis (RA) treated with tofacitinib.METHODS:
Phase II, III and long-term extension clinical trial data (April 2013 data-cut) from the tofacitinib RA programme were reviewed. OIs defined a priori included mycobacterial and fungal infections, multidermatomal herpes zoster and other viral infections associated with immunosuppression. For OIs, we calculated crude incidence rates (IRs; per 100 patient-years (95% CI)); for tuberculosis (TB) specifically, we calculated rates stratified by patient enrolment region according to background TB IR (per 100 patient-years) low (≤0.01), medium (>0.01 to ≤0.05) and high (>0.05).RESULTS:
We identified 60 OIs among 5671 subjects; all occurred among tofacitinib-treated patients. TB (crude IR 0.21, 95% CI of (0.14 to 0.30)) was the most common OI (n=26); median time between drug start and diagnosis was 64â weeks (range 15-161â weeks). Twenty-one cases (81%) occurred in countries with high background TB IR, and the rate varied with regional background TB IR low 0.02 (0.003 to 0.15), medium 0.08 (0.03 to 0.21) and high 0.75 (0.49 to 1.15). In Phase III studies, 263 patients diagnosed with latent TB infection were treated with isoniazid and tofacitinib concurrently; none developed TB. For OIs other than TB, 34 events were reported (crude IR 0.25 (95% CI 0.18 to 0.36)).CONCLUSIONS:
Within the global tofacitinib RA development programme, TB was the most common OI reported but was rare in regions of low and medium TB incidence. Patients who screen positive for latent TB can be treated with isoniazid during tofacitinib therapy.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Piperidinas
/
Artritis Reumatoide
/
Pirimidinas
/
Pirroles
/
Tuberculosis
/
Infecciones Oportunistas
/
Antirreumáticos
Tipo de estudio:
Etiology_studies
/
Incidence_studies
/
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
Ann Rheum Dis
Año:
2016
Tipo del documento:
Article
País de afiliación:
Estados Unidos