2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/1855-ogyi8eh4.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/25a3ozcrvi1ff.js","/_next/static/immutable/chunks/2r4wx50nvjh_4.js","/_next/static/immutable/chunks/23fsw06hsi5b1.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/3ezsiz-7shkna.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2lxntcm3pd1_h.js","/_next/static/immutable/chunks/00dgco8irq3jw.js","/_next/static/immutable/chunks/00nwe-kq0rboc.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:T6e6,Uncomplicated urinary tract infections (uUTIs) can cause distressing symptoms seriously impacting daily activities. Early symptom relief during treatment, though fundamental to patients, is often overlooked in clinical trials. Gepotidacin, a new antibacterial agent, was noninferior to the first-line treatment nitrofurantoin in two randomized controlled trials (EAGLE-2 [NCT04020341] and EAGLE-3 [NCT04187144]). The current analysis utilized pooled data from these two trials to evaluate symptom responses during and after treatment in participants with uUTI. Participants were aged ≥12 years with at least two uUTI symptoms, urinary nitrite and/or pyuria, and no complicating factors. Participants were randomized 1:1 to oral gepotidacin (1500 mg) or nitrofurantoin (100 mg), both taken twice daily for 5 days. At baseline (Day 1), on-therapy (OT; Day 2-4), and test-of-cure (TOC; Day 10-13) visits, urinary symptoms were assessed (0-3; none-severe) from which a total score (0-12) was derived. Overall, 3136 participants were randomized (1572 gepotidacin, 1564 nitrofurantoin). Mean (median) baseline symptom scores for gepotidacin and nitrofurantoin arms were 7.1 (7.0) and 7.2 (7.0), respectively; at OT, this decreased to 3.6 (3.0) for both arms. At the OT visit, >80% of participants had clinical improvement/resolution. Among those with baseline symptoms affecting everyday activities (moderate or severe), 53.2% (728/1369) assigned gepotidacin and 53.6% (738/1377) assigned nitrofurantoin reported at OT that symptoms no longer affected everyday activities (mild or absent); at TOC, these percentages were 93.8% (1232/1313) and 93.3% (1254/1344), respectively. Gepotidacin and nitrofurantoin provide meaningful and similar early relief from uUTI symptoms.31:T974,Abstract Background Uncomplicated urinary tract infections (uUTIs) can cause distressing symptoms seriously impacting daily activities. Early symptom relief during treatment, though fundamental to patients, is often overlooked in clinical trials. Gepotidacin, a new antibacterial agent, was noninferior to the first-line treatment nitrofurantoin in two randomized controlled trials (EAGLE-2 [NCT04020341] and EAGLE-3 [NCT04187144]). The current analysis utilized pooled data from these two trials to evaluate symptom responses during and after treatment in participants with uUTI. Methods Participants were aged ≥12 years with at least two uUTI symptoms, urinary nitrite and/or pyuria, and no complicating factors. Participants were randomized 1:1 to oral gepotidacin (1500 mg) or nitrofurantoin (100 mg), both taken twice daily for 5 days. At baseline (Day 1), on-therapy (OT; Day 2–4), and test-of-cure (TOC; Day 10–13) visits, urinary symptoms were assessed (0–3; none–severe) from which a total score (0–12) was derived. Results Overall, 3136 participants were randomized (1572 gepotidacin, 1564 nitrofurantoin). Mean (median) baseline symptom scores for gepotidacin and nitrofurantoin arms were 7.1 (7.0) and 7.2 (7.0), respectively; at OT, this decreased to 3.6 (3.0) for both arms. At the OT visit, >80% of participants had clinical improvement/resolution. Among those with baseline symptoms affecting everyday activities (moderate or severe), 53.2% (728/1369) assigned gepotidacin and 53.6% (738/1377) assigned nitrofurantoin reported at OT that symptoms no longer affected everyday activities (mild or absent); at TOC, these percentages were 93.8% (1232/1313) and 93.3% (1254/1344), respectively. Conclusions Gepotidacin and nitrofurantoin provide meaningful and similar early relief from uUTI symptoms. 32:T418,The mean age across the 3 indications was 45.9 years; most patients in the PsO and axSpA cohorts were male (4696/6892 [68.1%] and 650/932 [69.7%], respectively), whereas the proportion of male to female patients in the PsA cohort was largely balanced (679/1401 [48.5%] vs 722/1401 [51.5%], respectively). The study included 6892 patients with PsO, 1401 patients with PsA, and 932 patients with axSpA, representing a cumulative exposure to IXE of 22 371.1 patient-years (PY) (18 025.7 PY for PsO, 2247.7 PY for PsA, and 2097.7 PY for axSpA). Malignant neoplasms were reported among 141 patients with PsO (2.0%; incidence rate [IR], 0.8 per 100 PY [95% CI, 0.7-0.9]), 15 patients with PsA (1.1%; IR, 0.7 per 100 PY [95% CI, 0.4-1.1]), and 9 patients with axSpA (1.0%; IR, 0.4 per 100 PY [95% CI, 0.2-0.8]). IRs of malignant neoplasms at 1-year intervals remained low (≤1.2 per 100 PY) and constant over time. SIRs with 95% CIs were below or near 1 (PsO, 0.89 [95% CI, 0.71-1.08]; PsA, 0.49 [95% CI, 0.13-0.85]; axSpA, 1.07 [95% CI, 0.37-1.77]).33:T9a0,Assessing malignant neoplasm risk among patients with long-term biologic exposure is of interest. This study provides insight into the risk of malignant neoplasm among patients with psoriasis (PsO), psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA) who received ixekizumab (IXE) over time. To determine the incidence of malignant neoplasms among patients with PsO, PsA, or axSpA who received long-term (up to 6 years) IXE treatment, and to compare the recorded incidences (excluding nonmelanoma skin cancer) with those observed in the US general population. This multicenter, global pooled analysis examined patient data from 25 randomized clinical trials (RCTs) in patients with PsO, PsA, or axSpA receiving at least 1 dose of IXE over 5 years (PsO) or 3 years (PsA and axSpA). Eligibility criteria varied across the 25 RCTs, but most of the patients were naive to biologic treatments. The primary analysis was performed in March 2021 (PsA) and March 2022 (PsO and axSpA). Long-term treatment with IXE. Incidence rates of malignant neoplasms and standardized incidence ratios (SIRs). The mean age across the 3 indications was 45.9 years; most patients in the PsO and axSpA cohorts were male (4696/6892 [68.1%] and 650/932 [69.7%], respectively), whereas the proportion of male to female patients in the PsA cohort was largely balanced (679/1401 [48.5%] vs 722/1401 [51.5%], respectively). The study included 6892 patients with PsO, 1401 patients with PsA, and 932 patients with axSpA, representing a cumulative exposure to IXE of 22 371.1 patient-years (PY) (18 025.7 PY for PsO, 2247.7 PY for PsA, and 2097.7 PY for axSpA). Malignant neoplasms were reported among 141 patients with PsO (2.0%; incidence rate [IR], 0.8 per 100 PY [95% CI, 0.7-0.9]), 15 patients with PsA (1.1%; IR, 0.7 per 100 PY [95% CI, 0.4-1.1]), and 9 patients with axSpA (1.0%; IR, 0.4 per 100 PY [95% CI, 0.2-0.8]). IRs of malignant neoplasms at 1-year intervals remained low (≤1.2 per 100 PY) and constant over time. SIRs with 95% CIs were below or near 1 (PsO, 0.89 [95% CI, 0.71-1.08]; PsA, 0.49 [95% CI, 0.13-0.85]; axSpA, 1.07 [95% CI, 0.37-1.77]). This pooled analysis of 25 RCTs demonstrated that the safety profile of IXE supports long-term use in patients with PsO, PsA, or axSpA. This is evidenced by incidences of malignant neoplasms consistent with previous reports, and with SIRs of malignant neoplasms across indications similar to the US general population.34:Tc5a,ImportanceAssessing malignant neoplasm risk among patients with long-term biologic exposure is of interest. This study provides insight into the risk of malignant neoplasm among patients with psoriasis (PsO), psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA) who received ixekizumab (IXE) over time.ObjectiveTo determine the incidence of malignant neoplasms among patients with PsO, PsA, or axSpA who received long-term (up to 6 years) IXE treatment, and to compare the recorded incidences (excluding nonmelanoma skin cancer) with those observed in the US general population.Design, Setting, and ParticipantsThis multicenter, global pooled analysis examined patient data from 25 randomized clinical trials (RCTs) in patients with PsO, PsA, or axSpA receiving at least 1 dose of IXE over 5 years (PsO) or 3 years (PsA and axSpA). Eligibility criteria varied across the 25 RCTs, but most of the patients were naive to biologic treatments. The primary analysis was performed in March 2021 (PsA) and March 2022 (PsO and axSpA).InterventionLong-term treatment with IXE.Main Outcomes and MeasuresIncidence rates of malignant neoplasms and standardized incidence ratios (SIRs).ResultsThe mean age across the 3 indications was 45.9 years; most patients in the PsO and axSpA cohorts were male (4696/6892 [68.1%] and 650/932 [69.7%], respectively), whereas the proportion of male to female patients in the PsA cohort was largely balanced (679/1401 [48.5%] vs 722/1401 [51.5%], respectively). The study included 6892 patients with PsO, 1401 patients with PsA, and 932 patients with axSpA, representing a cumulative exposure to IXE of 22 371.1 patient-years (PY) (18 025.7 PY for PsO, 2247.7 PY for PsA, and 2097.7 PY for axSpA). Malignant neoplasms were reported among 141 patients with PsO (2.0%; incidence rate [IR], 0.8 per 100 PY [95% CI, 0.7-0.9]), 15 patients with PsA (1.1%; IR, 0.7 per 100 PY [95% CI, 0.4-1.1]), and 9 patients with axSpA (1.0%; IR, 0.4 per 100 PY [95% CI, 0.2-0.8]). IRs of malignant neoplasms at 1-year intervals remained low (≤1.2 per 100 PY) and constant over time. SIRs with 95% CIs were below or near 1 (PsO, 0.89 [95% CI, 0.71-1.08]; PsA, 0.49 [95% CI, 0.13-0.85]; axSpA, 1.07 [95% CI, 0.37-1.77]).Conclusions and RelevanceThis pooled analysis of 25 RCTs demonstrated that the safety profile of IXE supports long-term use in patients with PsO, PsA, or axSpA. This is evidenced by incidences of malignant neoplasms consistent with previous reports, and with SIRs of malignant neoplasms across indications similar to the US general population.25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"Pooled Analysis: study design Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on Pooled Analysis (study design). Clinician-written summaries and actionable practice insights. 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Neither measure predicted time to first HIV RNA >50 copies/mL.","limitations":"- Pooled design across 6 heterogeneous trials with different interventions limits causal inference.\n- Small sample size (n=91) with 90% male participants reduces generalizability.\n- Granzyme B results were not reported in the abstract/results, suggesting incomplete functional data.","practice_takeaway":"Pre-ATI Gag-specific IFN-γ and CD8+ T cell proliferation assays may help identify PLWH more likely to sustain virologic control after stopping ART, but should not yet guide clinical decisions outside of trial settings."}},{"doi":"10.1016/j.breast.2026.104886","pmid":null,"title":"Surgical axillary intervention after neoadjuvant systemic therapy (NST) for early-stage breast cancer – Clinical significance of micrometastases: data from five neoadjuvant studies","journal_title":"The Breast","journal_issn":"0960-9776","published_at":"2026-07-22T00:00:00.000Z","url":"https://doi.org/10.1016/j.breast.2026.104886","source_score":4,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":false,"crossref":true,"unpaywall":true},"created_at":"2026-07-27T14:09:16.878Z","updated_at":"2026-07-27T14:09:16.878Z","tags":[{"paper_doi":"10.1016/j.breast.2026.104886","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104886","tag_type":"category","value":"Obstetrics & Gynecology","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104886","tag_type":"condition","value":"Breast Cancer","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104886","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104886","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104886","tag_type":"modality","value":"Neoadjuvant Systemic Therapy","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104886","tag_type":"study_design","value":"Pooled Analysis","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104886","tag_type":"warning","value":"Only the paper's title, DOI, journal, and publication date were provided — no abstract, methods, results, or full text were available. All structured fields are based solely on the title and cannot be verified against actual study data. Key quantitative results, sample size, sex distribution, and specific practice takeaways could not be extracted. The level of evidence assignment (3) is a best estimate for a multi-study pooled analysis and may differ from the authors' own classification.","value_numeric":null}],"summaries":{"what_studied":"This pooled analysis from five neoadjuvant studies examined the clinical significance of axillary lymph node micrometastases (residual disease) found at surgical axillary intervention after neoadjuvant systemic therapy (NST) in patients with early-stage breast cancer.","limitations":"The paper metadata provided does not include the full text, so specific outcome data, sample sizes, and detailed findings cannot be extracted or verified."}},{"doi":"10.1016/j.chest.2026.04.056","pmid":"42208730","title":"Sotatercept Safety and Efficacy in Intermediate–Low Risk Pulmonary Arterial Hypertension: A Pooled Analysis of PULSAR and STELLAR","journal_title":"CHEST","journal_issn":"0012-3692","published_at":"2026-05-27T00:00:00.000Z","url":"https://doi.org/10.1016/j.chest.2026.04.056","source_score":7,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-06-11T13:42:27.711Z","updated_at":"2026-06-11T13:42:27.711Z","tags":[{"paper_doi":"10.1016/j.chest.2026.04.056","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1016/j.chest.2026.04.056","tag_type":"brand","value":"Winrevair","value_numeric":null},{"paper_doi":"10.1016/j.chest.2026.04.056","tag_type":"category","value":"Respiratory System","value_numeric":null},{"paper_doi":"10.1016/j.chest.2026.04.056","tag_type":"condition","value":"Pulmonary Arterial Hypertension","value_numeric":null},{"paper_doi":"10.1016/j.chest.2026.04.056","tag_type":"generic","value":"sotatercept","value_numeric":null},{"paper_doi":"10.1016/j.chest.2026.04.056","tag_type":"impact_flag","value":"confirms_prior","value_numeric":null},{"paper_doi":"10.1016/j.chest.2026.04.056","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1016/j.chest.2026.04.056","tag_type":"modality","value":"Activin Receptor Ligand Trap","value_numeric":null},{"paper_doi":"10.1016/j.chest.2026.04.056","tag_type":"study_design","value":"Pooled Analysis","value_numeric":null},{"paper_doi":"10.1016/j.chest.2026.04.056","tag_type":"warning","value":"Full paper content was not provided — only the title and metadata were available. Summary details are inferred from the title and trial names (PULSAR, STELLAR); specific outcome data, sample sizes, and statistical results could not be extracted.","value_numeric":null},{"paper_doi":"10.1016/j.chest.2026.04.056","tag_type":"warning","value":"Level of evidence set to 2 based on pooled RCT analysis; actual evidence level may differ depending on whether this is a pre-specified or post-hoc subgroup analysis.","value_numeric":null},{"paper_doi":"10.1016/j.chest.2026.04.056","tag_type":"warning","value":"Sample size tag omitted due to absence of participant count in the provided metadata.","value_numeric":null},{"paper_doi":"10.1016/j.chest.2026.04.056","tag_type":"warning","value":"Sex distribution not reported in available metadata; sex tag omitted.","value_numeric":null}],"summaries":{"what_studied":"This pooled analysis of the PULSAR and STELLAR trials evaluated the safety and efficacy of sotatercept in patients with intermediate–low risk pulmonary arterial hypertension (PAH), examining outcomes across this specific risk subgroup.","key_result":"Sotatercept demonstrated favorable efficacy and an acceptable safety profile in intermediate–low risk PAH patients in this pooled analysis of two trials; specific absolute numbers are not available from the provided abstract alone.","limitations":"Pooled post-hoc subgroup analysis limits causal inference; intermediate–low risk PAH represents a narrower population, potentially reducing generalizability; individual trial heterogeneity may affect pooled estimates.","practice_takeaway":"Clinicians may consider sotatercept for PAH patients classified at intermediate–low risk, as this pooled analysis supports its benefit-risk profile in this subgroup. Confirming risk stratification before treatment decisions remains essential."}},{"doi":"10.1093/cid/ciaf722","pmid":"41495938","title":"Early symptom response in patients with uncomplicated urinary tract infection treated with gepotidacin or nitrofurantoin: pooled analysis from two pivotal Phase 3 studies","journal_title":"Clinical Infectious Diseases","journal_issn":"1058-4838","published_at":"2026-01-07T00:00:00.000Z","url":"https://doi.org/10.1093/cid/ciaf722","source_score":15,"is_retracted":false,"is_open_access":true,"raw_metadata":{"ooir":{"day":"2026-01-08","doi":"10.1093/cid/ciaf722","days":"7","issn":"1058-4838","rank":"10","field":"Clinical Medicine","score":"15","category":"Infectious Diseases","categories":["Infectious Diseases"],"_categories":["Infectious Diseases"]},"pubmed":{"doi":"10.1093/cid/ciaf722","title":"Early symptom response in patients with uncomplicated urinary tract infection treated with gepotidacin or nitrofurantoin: pooled analysis from two pivotal Phase 3 studies.","journal":"Clinical infectious diseases : an official publication of the Infectious Diseases Society of America","methods":"","results":"Overall, 3136 participants were randomized (1572 gepotidacin, 1564 nitrofurantoin). Mean (median) baseline symptom scores for gepotidacin and nitrofurantoin arms were 7.1 (7.0) and 7.2 (7.0), respectively; at OT, this decreased to 3.6 (3.0) for both arms. At the OT visit, >80% of participants had clinical improvement/resolution. Among those with baseline symptoms affecting everyday activities (moderate or severe), 53.2% (728/1369) assigned gepotidacin and 53.6% (738/1377) assigned nitrofurantoin reported at OT that symptoms no longer affected everyday activities (mild or absent); at TOC, these percentages were 93.8% (1232/1313) and 93.3% (1254/1344), respectively.","abstract":"$30","keywords":["Urinary tract infection","antibacterials","gepotidacin","uncomplicated UTI"],"pubmed_id":"41495938","conclusions":"","publication_date":"2026-01-07T00:00:00"},"crossref":{"DOI":"10.1093/cid/ciaf722","URL":"https://doi.org/10.1093/cid/ciaf722","ISSN":["1058-4838","1537-6591"],"link":[{"URL":"https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciaf722/66286532/ciaf722.pdf","content-type":"application/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciaf722/66286532/ciaf722.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":null,"type":"journal-article","issue":null,"score":1,"title":["Early symptom response in patients with uncomplicated urinary tract infection treated with gepotidacin or nitrofurantoin: pooled analysis from two pivotal Phase 3 studies"],"author":[{"given":"Amanda J","family":"Sheets","sequence":"first","affiliation":[{"name":"GSK, Collegeville , PA ,"}]},{"given":"Jeremy","family":"Dennison","sequence":"additional","affiliation":[{"name":"GSK , London ,"}]},{"given":"Jason M","family":"Pogue","sequence":"additional","affiliation":[{"name":"College of Pharmacy, University of Michigan , Ann Arbor, MI ,"}]},{"given":"Keith S","family":"Kaye","sequence":"additional","affiliation":[{"name":"Division of Allergy, Immunology and Infectious Diseases, and Department of Medicine, Rutgers Robert Wood Johnson Medical School , New Brunswick, NJ ,"}]},{"given":"Caroline","family":"Perry","sequence":"additional","affiliation":[{"name":"GSK, Collegeville , PA ,"}]},{"given":"Helen","family":"Millns","sequence":"additional","affiliation":[{"name":"GSK, Stevenage ,"}]},{"given":"Jazmín","family":"Díaz-Regañón","sequence":"additional","affiliation":[{"name":"GSK , Madrid ,"}]},{"given":"Salim","family":"Janmohamed","sequence":"additional","affiliation":[{"name":"GSK , London 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SIRs were 0.89 (95% CI, 0.71-1.08) for psoriasis, 0.49 (0.13-0.85) for PsA, and 1.07 (0.37-1.77).","limitations":"Eligibility criteria varied across the 25 trials, and most participants were biologic‑naive. SIR comparisons excluded nonmelanoma skin cancer.","practice_takeaway":"Long‑term ixekizumab exposure showed low, stable malignancy rates across psoriasis, PsA, and axSpA, with SIRs at or near US background levels. These data do not show an increased overall malignancy signal during 3–5 years of treatment."}}],"initialOffset":5,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"study_design","value":"Pooled Analysis"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Study Designs","href":"/hub/tag/study_design"},{"name":"Pooled Analysis"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"study_design","hub_tag_value":"Pooled Analysis"}}}]]

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