Efficacy and Safety of Adjunctive Recombinant Human Interleukin-2 for Patients with Pulmonary Tuberculosis: A Meta-Analysis

Background. The results of previous clinical trials evaluating the efficacy and safety of recombinant human interleukin-2 (rhuIL-2) for adult patients with pulmonary tuberculosis showed inconsistent results. Accordingly, a comprehensive systematic review and meta-analysis was performed. Methods. Relevant randomized controlled trials (RCTs) were retrieved by searching the PubMed, Embase, Cochrane’s Library, Web of Science, Wanfang, and CNKI databases. A random-effects model was used to combine the results. Results. 18 RCTs with 2630 patients were included in this meta-analysis. Pooled results showed that adjunctive rhuIL-2 significantly increased the odds of sputum culture conversion to negative (risk ratio [RR]: 1.27, 95% CI: 1.09 to 1.47, <a:math xmlns:a="http://www.w3.org/1998/Math/MathML" id="M1"> <a:mi>p</a:mi> <a:mo>=</a:mo> <a:mn>0.002</a:mn> </a:math> , I2 = 80%), sputum smear conversion to negative (RR: 1.35, 95% CI: 1.17 to 1.57, <c:math xmlns:c="http://www.w3.org/1998/Math/MathML" id="M2"> <c:mi>p</c:mi> <c:mo>&lt;</c:mo> <c:mn>0.001</c:mn> </c:math> , I2 = 83%), radiographic focus absorption (RR: 1.17, 95% CI: 1.06 to 1.30, <e:math xmlns:e="http://www.w3.org/1998/Math/MathML" id="M3"> <e:mi>p</e:mi> <e:mo>=</e:mo> <e:mn>0.002</e:mn> </e:math> , I2 = 72), and cavity closure (RR: 1.24, 95% CI: 1.09 to 1.40, <g:math xmlns:g="http://www.w3.org/1998/Math/MathML" id="M4"> <g:mi>p</g:mi> <g:mo>&lt;</g:mo> <g:mn>0.001</g:mn> </g:math> , I2 = 23). The use of rhuIL-2 was not related to any severe adverse events which led to discontinuation of the treatment. Results showed that rhuIL-2 was related to an increased risk of fever (RR: 2.46, 95% CI: 1.29 to 4.70, <i:math xmlns:i="http://www.w3.org/1998/Math/MathML" id="M5"> <i:mi>p</i:mi> <i:mo>=</i:mo> <i:mn>0.006</i:mn> </i:math> , I2 = 0%). The incidence of other adverse events, such as musculoskeletal pain, hepatic injury, and renal toxicity, was not significantly different between groups ( <k:math xmlns:k="http://www.w3.org/1998/Math/MathML" id="M6"> <k:mi>p</k:mi> </k:math> all &gt;0.05). Conclusions. rhuIL-2 is an effective adjunctive immunotherapy for patients with pulmonary tuberculosis.