Background/Purpose:  Long-term extension studies and observational drug registers mainly from Western countries or non-endemic areas have reported an increased risk of tuberculosis (TB) infection in patients under biological DMARD (bDMARD) therapy. However, information about TB infection in patients with inflammatory arthropathies in daily clinical practice in endemic areas is limited. Our aim was to describe a series of TB infection in patients who received bDMARD treatment and to identify which patients were able to resume bDMARD therapy.

Methods:  We included patients with inflammatory arthropathies treated at Medicarte IPS from March 2009 to March 2016. Medicarte is a referral center for the integral medical care and pharmaco-surveillance of patients under biologic therapies in 13 cities in Colombia for inflammatory arthropathies, mainly rheumatoid arthritis (RA), psoriatic arthritis (PsA) and spondyloartropathies (Spa), psoriasis and inflammatory bowel disease (IBD) among others. Clinical information was obtained from electronic clinical records and medical claims. In addition, clinical records from admissions were reviewed for relevant information related with TB. Only those cases with a confirmed diagnosis of TB, either by sputum, biopsies or tissues cultures were included.

Results:  Among 6,508 patients under biological treatment followed in our centers, we identified 54 patients who develop a TB infection. Those patients with diagnosis of IBD (N=3) or psoriasis (N=8) were excluded. 13 cases who only received DMARD therapy [methotrexate (MTX) =2 and leflunomide (LEF)=11] were not included. Finally, our sample included 28 patients with inflammatory arthropathies. 68% of patients were female, with a mean age at the moment of TB infection of 50.5 ± 14.7 years. Diagnoses were: 20 RA; 6 Spa; 1 Psa and 1 Spa related with Crohn’s disease. None of the patients had concomitant HIV infection. Pulmonary TB was diagnosed in 15 (53.6%) of patients, followed by disseminated TB in 5 (18%), pleural TB in 3 (11%) and laryngeal, miliary, bone, intestinal and lymph node TB in one case each. At the time of TB infection 64% were under steroids treatment (mean dose 7.9 ± 5.9 mg/d), 32% received MTX, 36% LEF and 21% chloroquine. bDMARD treatment before TB infections were as follows: Adalimumab in 13 (46%) patients, infliximab in 6 (21%), etanercept in 5 (18%), abatacept in 2 (7%) and rituximab and certolizumab in 1 case each. Mean time of TB treatment was 8.2 ± 2.0 months. Two patients died as a direct consequence of TB infection. Thirteen (46%) out of 28 patients resume bDMARD after TB treatment. Five out of 13 patients reinitiated with the same biological agent. Mean follow-up of bDMARD therapy after TB infection was 15.7 ± 18.1 months. No new cases of TB infection have been reported during the follow-up.

Conclusion:  In daily clinical practice in an endemic TB country, around half of patients with TB infection were able to resume bDMARD treatment. Extra-pulmonary TB represented more than 40% of cases of TB. In endemic TB countries, a TB infection does not preclude reinitiating of bDMARD therapy.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/resume-of-biologic-therapy-after-tuberculosis-infection-in-patients-with-inflammatory-arthropathies-daily-clinical-practice-data-from-an-endemic-country/