33 research outputs found

    Pembrolizumab versus the standard of care for relapsed and refractory classical Hodgkin’s lymphoma progressing after brentuximab vedotin: an indirect treatment comparison

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    <p><b>Background</b>: There is significant unmet need among patients with relapsed and refractory classical Hodgkin’s lymphoma (RRcHL) who have failed multiple lines of therapy, including brentuximab vedotin (BV). Pembrolizumab, an immune checkpoint inhibitor, is one possible treatment solution for this population.</p> <p><b>Research methods</b>: The objective of this study was to compare progression-free survival (PFS) with standard of care (SOC) versus pembrolizumab in previously BV treated RRcHL patients. A systematic literature review identified one observational study of SOC that was suitable for comparison with KEYNOTE-087, the principal trial of pembrolizumab in this population. Both naïve and population-adjusted (using outcomes regression) pairwise indirect comparisons were conducted. The primary analysis included all patients who had failed BV, with a secondary analysis conducted including only those known to have failed BV that was part of definitive treatment.</p> <p><b>Results</b>: In the primary analysis, SOC was inferior to pembrolizumab in both the unadjusted comparison (HR 5.00 [95% confidence interval (CI) 3.56–7.01]) and the adjusted comparison (HR 6.35 [95% CI 4.04–9.98]). These HRs increased to 5.16 (95% CI 3.61–7.38) and 6.56 (95% CI 4.01–10.72), respectively, in the secondary analysis.</p> <p><b>Conclusion</b>: Pembrolizumab offers a significant improvement in PFS compared to SOC in this population.</p

    Adjusted cumulative incidence of all-cause mortality among HIV-positive injection drug users initiating antiretroviral therapy in British Columbia, stratified by hunger status.

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    <p>Adjusted cumulative incidence of all-cause mortality among HIV-positive injection drug users initiating antiretroviral therapy in British Columbia, stratified by hunger status.</p

    Integrating efficacy and safety of vedolizumab compared with other advanced therapies to assess net clinical benefit of ulcerative colitis treatments: a network meta-analysis

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    Because only one head-to-head randomized trial of biologics for moderate-to-severe UC has been performed, indirect treatment comparisons remain important. This systematic review and network meta-analysis examined efficacy and safety of biologics and tofacitinib for moderate-to-severe UC, using vedolizumab as reference. Relevant studies (N = 19) of vedolizumab, adalimumab, infliximab, golimumab, ustekinumab, and tofacitinib were identified. Study design differences were addressed by assessing efficacy outcomes conditional on response at maintenance initiation. Primary analysis used fixed-effect models to estimate odds ratios for efficacy and safety endpoints. Compared with vedolizumab 300 mg, adalimumab 160/80 mg was associated with less clinical remission (odds ratio, 0.69 [95% credible interval, 0.54–0.88]), and infliximab 5 mg/kg was associated with more clinical remission (1.67 [1.16–2.42]) and response (1.63 [1.15–2.30]). Adalimumab 40 mg, golimumab 50 mg, and ustekinumab 90 mg Q12W had significantly lower clinical remission rates during maintenance (0.62 [0.45–0.86], 0.55 [0.32–0.95], and 0.59 [0.35–0.99]) versus vedolizumab 300 mg Q8W. Response results were similar. Tofacitinib 10 mg had the highest maintenance treatment efficacy estimates and highest infection risk. Network meta-analysis and novel integrated benefit-risk analysis suggest a potentially favorable efficacy-safety balance for vedolizumab vs adalimumab and other advanced UC therapies.</p

    Adjusted cumulative incidence of all-cause mortality among HIV-positive injection drug users initiating antiretroviral therapy in British Columbia, stratified by food security status.

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    <p>Adjusted cumulative incidence of all-cause mortality among HIV-positive injection drug users initiating antiretroviral therapy in British Columbia, stratified by food security status.</p
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