Incidence of tuberculosis among patients with rheumatoid arthritis using TNF blockers in Brazil: data from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (Registro Brasileiro de Monitoração de Terapias Biológicas – BiobadaBrasil)

Yonekura, Cláudia Leiko; Oliveira, Renê Donizeti Ribeiro de; Titton, D.; Ranza, Roberto; Ranzolin, Aline; Hayata, A. L. S.; Duarte, Ângela Luzia Branco Pinto; Silveira, Inês Guimarães da; Carvalho, H.; Moraes, Júlio César Bertacini de; Abreu, Mirhelen Mendes de; Valim, Valéria; Bianchi, W.; Brenol, Claiton Viegas; Pereira, Ivânio Alves; Costa, Izaías Pereira da; Macieira, José Caetano; Miranda, José Roberto Silva; Guedes-Barbosa, Luíz Sérgio; Bértolo, Manoel Barros; Sauma, Maria de Fátima Lobato da Cunha; Silva, Marília B. G.; Freire, Marlene; Scheinberg, Morton; Toledo, Roberto Acayaba de; Oliveira, Sheila Knupp Feitosa de; Fernandes, Vander; Pinheiro, Marcelo M.; Castro, Gláucio Ricardo Werner de; Vieira, Walber Pinto; Baaklini, C.; Ruffino-Netto, Antônio; Pinheiro, Geraldo da Rocha Castelar; Laurindo, Iêda Maria Magalhães; Louzada‐Júnior, Paulo

doi:10.1016/j.rbre.2017.05.005

Cited by 22 publications

(27 citation statements)

References 29 publications

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“…The highest rate of serious active TB was found among patients with Ps, RA, PsA, and UV. The rates of serious opportunistic infections and active TBs were similar to the previous analysis [3] and were consistent with rates reported for adalimumab and other TNF inhibitors in clinical and real-world registry studies [86,[92][93][94][95][96].…”

Section: Discussionsupporting

confidence: 88%

Long-Term Safety of Adalimumab in 29,967 Adult Patients From Global Clinical Trials Across Multiple Indications: An Updated Analysis

et al. 2019

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Introduction: The safety profile of adalimumab was previously reported in 23,458 patients across multiple indications. Here we report the long-term safety of adalimumab in adults with plaque psoriasis (Ps), hidradenitis suppurativa (HS), rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, non-radiographic axial spondyloarthritis, peripheral spondyloarthritis, Crohn's disease (CD), ulcerative colitis (UC), and non-infectious uveitis (UV). Methods: Safety data from 77 clinical trials were pooled. Safety assessments included adverse events (AEs) and serious AEs (SAEs) that occurred after the first study dose and within 70 days (5 half-lives) after the last study dose. Results: A total of 29,967 patients were included, representing 56,916 patient-years (PY) of exposure. The most frequently reported SAE of interest was infection (3.7/100 PY) with highest incidences in CD, RA, UV, and UC (3.5/ 100 PY-6.9/100 PY); serious infections in Ps (1.8/100 PY) and HS (2.8/100 PY) were lower. The observed number of deaths was below what would be expected in an age-and sex-adjusted population for most adalimumab-treated patients (including Ps). Lack of real-life data and limited long-term data ([ 5 years) for most patients are limitations of this analysis. Conclusion: The safety profile of adalimumab was consistent with previous findings and no new safety signals were observed.

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Section: Discussionsupporting

confidence: 88%

Long-Term Safety of Adalimumab in 29,967 Adult Patients From Global Clinical Trials Across Multiple Indications: An Updated Analysis

et al. 2019

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“…A higher frequency of extra-pulmonary TB in biologicexposed patients as compared with TB in the general population has been recorded. In the largest clinical series the frequency of the extra-pulmonary TB ranged from 27% to 62% of the TB reactivation cases [108,109,112,113], while no differences in terms of response to anti-TB therapy emerged in comparison with the general population.…”

Section: Non-anti-tnf Targeted Biologicsmentioning

confidence: 89%

“…Apart from the burden of active TB in biologic-exposed patients with RA, PsA, and AS, another interesting issue has been raised overtime concerning the clinical characteristics of active TB infection in these patients. Active TB predominantly occurred in females, with proportions ranging from 60% to 100% [66,82,[108][109][110][111][112]. However, it should be taken in account that most of the cases were recorded in patients with RA, a disease associated with the female gender (female:male = 4:1).…”

Section: Non-anti-tnf Targeted Biologicsmentioning

confidence: 99%

Preventive therapy for tuberculosis in rheumatological patients undergoing therapy with biological drugs

Goletti

Petrone

Ippolito

et al. 2018

Expert Review of Anti-infective Therapy

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Latent tuberculosis infection (LTBI) accounts for almost a quarter of the world population, and, in 5-10% of the subjects with impaired immune-response against M. tuberculosis growth, it may progress to active tuberculosis (TB). In this review, we focus on the need to propose a screening for LTBI including preventive therapy offer in rheumatic patients undergoing therapy with biological drugs. Areas covered: We report on evidence that biologics are associated with an increased risk of active TB reactivation. This effect seems to be mainly limited to treatment with anti-tumor necrosis factor (TNF) agents, while non-anti-TNF-targeted biologics are not likely associated to any increased risk. We introduce the concept that the patients' coexisting host-related risk factors, such as comorbidities, are crucial to identify those at higher risk to reactivate TB. We report that preventive TB therapy is well tolerated in patients treated with biological drugs. Expert commentary: Availability of non-anti-TNF targeted biologics, that are not associated with an increased risk of TB reactivation, offers a great opportunity to tailor a therapeutic intervention at low/absent TB risk. After proper LTBI screening investigations, preventive TB therapy has been demonstrated to be effective and well-tolerated to reduce the risk of TB reactivation in rheumatic patients requiring biological drugs.

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“…In South America, tuberculosis remains an endemic disease with an incidence of 41 (35-47)/100,000 in Brazil and 25 (22)(23)(24)(25)(26)(27)(28)(29)/100,000 in Argentina [20]. It was therefore expected a tuberculosis IR for all bDMARDs higher in Brazil (1.46/1000) than in Argentina (0.63), and the overall IR of 1.4/1000 found in this study reflects the background risk in our countries [21].…”

Section: Discussionmentioning

confidence: 99%

“…In a previous paper on tuberculosis in RA patients included in BIOBADABRASIL through 2013, the incidence was 2.87/ 1000 in the TNFi group, and 1 event was observed in the control group. That control patient was not included in the present analysis because the patient's condition was not classified as a SI [22]. Two cases of pulmonary tuberculosis were identified in the BIOBADASAR control group, but again, these were classified as not serious, and both achieved recovery [unpublished data].…”

Section: Discussionmentioning

confidence: 99%

Changing rate of serious infections in biologic-exposed rheumatoid arthritis patients. Data from South American registries BIOBADABRASIL and BIOBADASAR

Ranza¹,

Vega²,

Laurindo³

et al. 2019

Clin Rheumatol

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Objective Most reports on serious infections (SI) in rheumatoid arthritis (RA) patients treated with biological disease-modifying antirheumatic drugs (bDMARDs) are from the USA and Western Europe. Data from other regions are largely missing. We report data from South American countries with different backgrounds and health-care systems but similar registries. Methods We merged 2010-2016 data from two registries, BIOBADABRASIL (Brazil) and BIOBADASAR (Argentina), which share the same protocol, online platform and data monitoring process. Patients with active RA were included when they began the first bDMARD or a conventional synthetic DMARD (csDMARD, control group). The SI incidence rate (IR) per 1000 patient/ years and adjusted IR ratio (aIRR) were estimated for bDMARDs and csDMARDs. Results Data were analysed for 3717 RA patients with an exposure of 13,380 patient/years. The 2591 patients treated with bDMARDs (64% tumour necrosis factor-α inhibitors (TNFi)) had a follow-up of 9300 years, and the 1126 treated with csDMARDs had an exposure of 4081 patient/years. The SI IR was 30.54 (CI 27.18-34.30) for all bDMARDs and 5.15 (CI 3.36-7.89) for csDMARDs. The aIRR between the two groups was 2.03 ([1.05, 3.9] p = 0.034) for the first 6 months of treatment but subsequently increased to 8.26 ([4.32, 15.76] p < 0.001). The SI IR for bDMARDs decreased over time in both registries, dropping from 36.59 (28.41-47.12) in 2012 to 7.27 (4.79-11.05) in 2016. Conclusion While SI remains a major concern in South American patients with RA treated with bDMARDs, a favourable trend toward a reduction was observed in the last years. Key Points • New comprehensive data on biologic drugs safety from international collaboration in South America. • First proposal for national registries data merging in South America. • Serious infections remain a major concern in RA patients treated with biologics. • A significant reduction of serious infections in RA patients exposed to biologics was observed over a 7 years period.

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Incidence of tuberculosis among patients with rheumatoid arthritis using TNF blockers in Brazil: data from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (Registro Brasileiro de Monitoração de Terapias Biológicas – BiobadaBrasil)

Abstract: The incidence of tuberculosis was higher among users of synthetic DMARDs and anti-TNF than among users of synthetic DMARDs and synthetic DMARDs and non-anti-TNF biologics and also occurred later, suggesting infection during treatment and no screening failure.

Cited by 22 publications

References 29 publications

Long-Term Safety of Adalimumab in 29,967 Adult Patients From Global Clinical Trials Across Multiple Indications: An Updated Analysis

Long-Term Safety of Adalimumab in 29,967 Adult Patients From Global Clinical Trials Across Multiple Indications: An Updated Analysis

Preventive therapy for tuberculosis in rheumatological patients undergoing therapy with biological drugs

Changing rate of serious infections in biologic-exposed rheumatoid arthritis patients. Data from South American registries BIOBADABRASIL and BIOBADASAR

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