Randomized placebo-controlled trial of prednisone for paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome

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dc.contributor.authorMeintjes, Graeme
dc.contributor.authorWilkinson, Robert J
dc.contributor.authorMorroni, Chelsea
dc.contributor.authorPepper, Dominique J
dc.contributor.authorRebe, Kevin
dc.contributor.authorRangaka, Molebogeng X
dc.contributor.authorOni, Tolu
dc.contributor.authorMaartens, Gary
dc.date.accessioned2016-07-19T07:55:34Z
dc.date.available2016-07-19T07:55:34Z
dc.date.issued2010
dc.date.updated2016-07-05T10:08:47Z
dc.description.abstractObjective: Paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome (TB-IRIS) is a frequent complication of antiretroviral therapy in resource-limited countries. We aimed to assess whether a 4 week course of prednisone would reduce morbidity in patients with paradoxical TB-IRIS without excess adverse events. Design: A randomised double blind placebo-controlled trial of prednisone (1.5mg/kg/day for 2 weeks then 0.75mg/kg/day for 2 weeks). Patients with immediately life-threatening TB-IRIS manifestations were excluded. Methods: The primary combined endpoint was days of hospitalization and outpatient therapeutic procedures, which were counted as one hospital day. Results: 110 participants were enrolled (55 to each arm). The primary combined endpoint was more frequent in the placebo than the prednisone arm (median hospital days 3 (IQR 0-9) and 0 (IQR 0-3) respectively; p=0.04). There were significantly greater improvements in symptoms, Karnofsky score, and quality of life (MOS-HIV) in the prednisone versus the placebo arm at 2 and 4 weeks, but not at later timepoints. Chest radiographs improved significantly more in the prednisone arm at weeks 2 (p=0.002) and 4 (p=0.02). Infections on study medication occurred in more participants in prednisone than placebo arm (27 vs 17 respectively; p=0.05), but there was no difference in severe infections (2 vs 4 respectively; p=0.40). Isolates from 10 participants were found to be resistant to rifampicin after enrollment. Conclusions: Prednisone reduced the need for hospitalisation and therapeutic procedures, and hastened improvements in symptoms, performance and quality of life. It is important to investigate for drug-resistant tuberculosis and other causes for deterioration before administering glucocorticoids.en_ZA
dc.identifierhttp://dx.doi.org/10.1097/QAD.0b013e32833dfc68
dc.identifier.apacitationMeintjes, G., Wilkinson, R. J., Morroni, C., Pepper, D. J., Rebe, K., Rangaka, M. X., ... Maartens, G. (2010). Randomized placebo-controlled trial of prednisone for paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome. <i>AIDS</i>, http://hdl.handle.net/11427/20446en_ZA
dc.identifier.chicagocitationMeintjes, Graeme, Robert J Wilkinson, Chelsea Morroni, Dominique J Pepper, Kevin Rebe, Molebogeng X Rangaka, Tolu Oni, and Gary Maartens "Randomized placebo-controlled trial of prednisone for paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome." <i>AIDS</i> (2010) http://hdl.handle.net/11427/20446en_ZA
dc.identifier.citationMeintjes, G., Wilkinson, R. J., Morroni, C., Pepper, D. J., Rebe, K., Rangaka, M. X., ... & Maartens, G. (2010). Randomized placebo-controlled trial of prednisone for paradoxical TB-associated immune reconstitution inflammatory syndrome. AIDS (London, England), 24(15), 2381.en_ZA
dc.identifier.issn0269-9370en_ZA
dc.identifier.ris TY - Journal Article AU - Meintjes, Graeme AU - Wilkinson, Robert J AU - Morroni, Chelsea AU - Pepper, Dominique J AU - Rebe, Kevin AU - Rangaka, Molebogeng X AU - Oni, Tolu AU - Maartens, Gary AB - Objective: Paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome (TB-IRIS) is a frequent complication of antiretroviral therapy in resource-limited countries. We aimed to assess whether a 4 week course of prednisone would reduce morbidity in patients with paradoxical TB-IRIS without excess adverse events. Design: A randomised double blind placebo-controlled trial of prednisone (1.5mg/kg/day for 2 weeks then 0.75mg/kg/day for 2 weeks). Patients with immediately life-threatening TB-IRIS manifestations were excluded. Methods: The primary combined endpoint was days of hospitalization and outpatient therapeutic procedures, which were counted as one hospital day. Results: 110 participants were enrolled (55 to each arm). The primary combined endpoint was more frequent in the placebo than the prednisone arm (median hospital days 3 (IQR 0-9) and 0 (IQR 0-3) respectively; p=0.04). There were significantly greater improvements in symptoms, Karnofsky score, and quality of life (MOS-HIV) in the prednisone versus the placebo arm at 2 and 4 weeks, but not at later timepoints. Chest radiographs improved significantly more in the prednisone arm at weeks 2 (p=0.002) and 4 (p=0.02). Infections on study medication occurred in more participants in prednisone than placebo arm (27 vs 17 respectively; p=0.05), but there was no difference in severe infections (2 vs 4 respectively; p=0.40). Isolates from 10 participants were found to be resistant to rifampicin after enrollment. Conclusions: Prednisone reduced the need for hospitalisation and therapeutic procedures, and hastened improvements in symptoms, performance and quality of life. It is important to investigate for drug-resistant tuberculosis and other causes for deterioration before administering glucocorticoids. DA - 2010 DB - OpenUCT DP - University of Cape Town J1 - AIDS KW - Immune reconstitution inflammatory syndrome KW - IRIS KW - tuberculosis KW - HIV KW - glucocorticoids KW - prednisone KW - antiretroviral therapy LK - https://open.uct.ac.za PB - University of Cape Town PY - 2010 SM - 0269-9370 T1 - Randomized placebo-controlled trial of prednisone for paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome TI - Randomized placebo-controlled trial of prednisone for paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome UR - http://hdl.handle.net/11427/20446 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/20446
dc.identifier.urihttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC2940061/
dc.identifier.vancouvercitationMeintjes G, Wilkinson RJ, Morroni C, Pepper DJ, Rebe K, Rangaka MX, et al. Randomized placebo-controlled trial of prednisone for paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome. AIDS. 2010; http://hdl.handle.net/11427/20446.en_ZA
dc.languageengen_ZA
dc.publisherLippincott, Williams & Wilkinsen_ZA
dc.publisher.departmentInstitute of Infectious Disease and Molecular Medicineen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.sourceAIDSen_ZA
dc.source.urihttp://www.lww.com/product/?0269-9370
dc.subjectImmune reconstitution inflammatory syndrome
dc.subjectIRIS
dc.subjecttuberculosis
dc.subjectHIV
dc.subjectglucocorticoids
dc.subjectprednisone
dc.subjectantiretroviral therapy
dc.titleRandomized placebo-controlled trial of prednisone for paradoxical tuberculosis-associated immune reconstitution inflammatory syndromeen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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