2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/2iy5wruuedsh6.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/00yc7rcvua6a7.js","/_next/static/immutable/chunks/37ktb71aq3480.js","/_next/static/immutable/chunks/2d50b-7eu4558.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/2d6noqpp6ehas.js","/_next/static/immutable/chunks/1sx186c93bpzg.js","/_next/static/immutable/chunks/3dc-1n866s65i.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2w1bvggzb0ga8.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:T400,Of 185 guselkumab-randomized participants in the primary efficacy analysis set, 151 participated in the LTE. Among those continuing treatment, with available data (as observed), 97.7% (n = 85 of 87) achieved clinical remission, 71.3% (n = 62 of 87) achieved endoscopic response, and 51.7% (n = 45 of 87) achieved endoscopic remission at week 240. Results from NRI analyses also showed durability of efficacy (eg, week-240 clinical remission: 59.2% [n = 84 of 142], LTE analysis set; 46.0% [n = 81 of 176], primary efficacy analysis set). High rates of clinical and endoscopic remission at week 240 were maintained in biologic-naive participants (97.8% [n = 45 of 46] and 54.3% [n = 25 of 46], respectively [as-observed]) and participants with an inadequate response or intolerance to biologic therapy (97.1% [n = 34 of 35] and 54.3% [n = 19 of 35], respectively [as-observed]). Event rates of serious adverse events, discontinuations due to adverse events, and serious infections were low in guselkumab-treated participants.31:T920,The randomized, phase 2 GALAXI 1 study evaluated efficacy and safety of guselkumab, a dual-acting IL-23p19 subunit inhibitor, in participants with moderately to severely active Crohn's disease. Efficacy and safety through 5 years are reported. After completing the 48-week, treat-through GALAXI 1 main study, participants could enter the long-term extension (LTE) and continue the subcutaneous maintenance regimen assigned at randomization. Efficacy for the combined guselkumab dose groups was analyzed by (1) as-observed analysis of LTE participants, (2) nonresponder imputation (NRI) analysis of LTE participants, and (3) NRI analysis of primary efficacy analysis set (all [week 0] randomized participants). The study was not designed for statistical comparisons between groups. Of 185 guselkumab-randomized participants in the primary efficacy analysis set, 151 participated in the LTE. Among those continuing treatment, with available data (as observed), 97.7% (n = 85 of 87) achieved clinical remission, 71.3% (n = 62 of 87) achieved endoscopic response, and 51.7% (n = 45 of 87) achieved endoscopic remission at week 240. Results from NRI analyses also showed durability of efficacy (eg, week-240 clinical remission: 59.2% [n = 84 of 142], LTE analysis set; 46.0% [n = 81 of 176], primary efficacy analysis set). High rates of clinical and endoscopic remission at week 240 were maintained in biologic-naive participants (97.8% [n = 45 of 46] and 54.3% [n = 25 of 46], respectively [as-observed]) and participants with an inadequate response or intolerance to biologic therapy (97.1% [n = 34 of 35] and 54.3% [n = 19 of 35], respectively [as-observed]). Event rates of serious adverse events, discontinuations due to adverse events, and serious infections were low in guselkumab-treated participants. Long-term guselkumab treatment showed sustained clinical and endoscopic efficacy through week 240. The long-term safety data were consistent with those previously presented in approved indications. A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (GALAXI), NCT03466411, https://clinicaltrials.gov/study/NCT03466411. Guselkumab demonstrated durable clinical and endoscopic efficacy and remained well tolerated through up to 5 years in the phase 2 GALAXI 1 study.32:Tbb7,Abstract Background The randomized, phase 2 GALAXI 1 study evaluated efficacy and safety of guselkumab, a dual-acting IL-23p19 subunit inhibitor, in participants with moderately to severely active Crohn’s disease. Efficacy and safety through 5 years are reported. Methods After completing the 48-week, treat-through GALAXI 1 main study, participants could enter the long-term extension (LTE) and continue the subcutaneous maintenance regimen assigned at randomization. Efficacy for the combined guselkumab dose groups was analyzed by (1) as-observed analysis of LTE participants, (2) nonresponder imputation (NRI) analysis of LTE participants, and (3) NRI analysis of primary efficacy analysis set (all [week 0] randomized participants). The study was not designed for statistical comparisons between groups. Results Of 185 guselkumab-randomized participants in the primary efficacy analysis set, 151 participated in the LTE. Among those continuing treatment, with available data (as observed), 97.7% (n = 85 of 87) achieved clinical remission, 71.3% (n = 62 of 87) achieved endoscopic response, and 51.7% (n = 45 of 87) achieved endoscopic remission at week 240. Results from NRI analyses also showed durability of efficacy (eg, week-240 clinical remission: 59.2% [n = 84 of 142], LTE analysis set; 46.0% [n = 81 of 176], primary efficacy analysis set). High rates of clinical and endoscopic remission at week 240 were maintained in biologic-naive participants (97.8% [n = 45 of 46] and 54.3% [n = 25 of 46], respectively [as-observed]) and participants with an inadequate response or intolerance to biologic therapy (97.1% [n = 34 of 35] and 54.3% [n = 19 of 35], respectively [as-observed]). Event rates of serious adverse events, discontinuations due to adverse events, and serious infections were low in guselkumab-treated participants. Conclusions Long-term guselkumab treatment showed sustained clinical and endoscopic efficacy through week 240. The long-term safety data were consistent with those previously presented in approved indications. Clinical trial registration A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn’s Disease (GALAXI), NCT03466411, https://clinicaltrials.gov/study/NCT03466411 33:T7eb,To evaluate the efficacy and safety of guselkumab, an interleukin-23p19 subunit inhibitor, in participants with active psoriatic arthritis (PsA) and inadequate response (inadequate efficacy and/or intolerance) to one prior tumor necrosis factor (TNF) inhibitor. In SOLSTICE (phase 3b, randomized, multicenter, double-blind, placebo-controlled study), enrolled adults with active PsA (three or more swollen joints; three or more tender joints; C-reactive protein ≥ 0.3 mg/dL) and inadequate response to one prior TNF inhibitor were randomized to guselkumab 100 mg every 4 weeks (Q4W), guselkumab 100 mg at weeks 0 and 4 and then Q8W, or placebo with crossover to guselkumab Q4W at week 24. The primary endpoint was ≥20% improvement in American College of Rheumatology criteria (ACR20) at week 24. Secondary endpoints included ACR50, ACR70, Investigator's Global Assessment of psoriasis (IGA) score of 0 or 1 with ≥2-grade improvement, ≥90% improvement in Psoriasis Area and Severity Index (PASI90), and minimal disease activity (MDA) at week 24 and were analyzed by intention-to-treat. Analyses included 451 randomized participants (Q4W n = 150; Q8W n = 151; placebo n = 150). At week 24, significantly greater proportions of guselkumab (Q4W/Q8W)-treated participants versus placebo-treated participants, respectively, achieved ACR20 (primary endpoint: 58.6%/62.2% vs 34.8%), ACR50 (31.4%/32.1% vs 12.2%), ACR70 (17.5%/17.3% vs 2.0%), IGA 0/1 response (50.0%/57.3% vs 17.4%), PASI90 (49.4%/45.5% vs 12.0%), and MDA (18.8%/23.9% vs 5.4%) (all P < 0.001). Through week 24, 46.7%, 53.6%, and 48.3% of participants receiving guselkumab Q4W, guselkumab Q8W, and placebo, respectively, had one or more adverse event. One death occurred (myocardial infarction). Comparable efficacy was observed with both guselkumab regimens in participants with active PsA and inadequate response to one prior TNF inhibitor; safety findings were consistent with the known profile of guselkumab in patients with psoriatic disease.34:Tc9f, Objective To evaluate the efficacy and safety of guselkumab, an interleukin‐23p19 subunit inhibitor, in participants with active psoriatic arthritis (PsA) and inadequate response (inadequate efficacy and/or intolerance) to one prior tumor necrosis factor (TNF) inhibitor. Methods In SOLSTICE (phase 3b, randomized, multicenter, double‐blind, placebo‐controlled study), enrolled adults with active PsA (three or more swollen joints; three or more tender joints; C‐reactive protein ≥ 0.3 mg/dL) and inadequate response to one prior TNF inhibitor were randomized to guselkumab 100 mg every 4 weeks (Q4W), guselkumab 100 mg at weeks 0 and 4 and then Q8W, or placebo with crossover to guselkumab Q4W at week 24. The primary endpoint was ≥20% improvement in American College of Rheumatology criteria (ACR20) at week 24. Secondary endpoints included ACR50, ACR70, Investigator's Global Assessment of psoriasis (IGA) score of 0 or 1 with ≥2‐grade improvement, ≥90% improvement in Psoriasis Area and Severity Index (PASI90), and minimal disease activity (MDA) at week 24 and were analyzed by intention‐to‐treat. Results Analyses included 451 randomized participants (Q4W n = 150; Q8W n = 151; placebo n = 150). At week 24, significantly greater proportions of guselkumab (Q4W/Q8W)‐treated participants versus placebo‐treated participants, respectively, achieved ACR20 (primary endpoint: 58.6%/62.2% vs 34.8%), ACR50 (31.4%/32.1% vs 12.2%), ACR70 (17.5%/17.3% vs 2.0%), IGA 0/1 response (50.0%/57.3% vs 17.4%), PASI90 (49.4%/45.5% vs 12.0%), and MDA (18.8%/23.9% vs 5.4%) (all P < 0.001). Through week 24, 46.7%, 53.6%, and 48.3% of participants receiving guselkumab Q4W, guselkumab Q8W, and placebo, respectively, had one or more adverse event. One death occurred (myocardial infarction). Conclusion Comparable efficacy was observed with both guselkumab regimens in participants with active PsA and inadequate response to one prior TNF inhibitor; safety findings were consistent with the known profile of guselkumab in patients with psoriatic disease.

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no meta-analysis was conducted due to methodological heterogeneity.","value_numeric":null},{"paper_doi":"10.2340/actadv.v106.adv-2026-0797","tag_type":"warning","value":"Sex tag set to 'female' as the primary dataset covers maternal exposure; paternal exposure studies also exist but are a small subset (3 studies, 281 pregnancies).","value_numeric":null},{"paper_doi":"10.2340/actadv.v106.adv-2026-0797","tag_type":"warning","value":"The review included all indications for IL inhibitors (not psoriasis-only), so findings may not be fully generalizable to psoriasis patients specifically.","value_numeric":null},{"paper_doi":"10.2340/actadv.v106.adv-2026-0797","tag_type":"warning","value":"The sample size (n=5,962) reflects maternal pregnancy exposures across all included studies, not a single trial cohort; the majority originated from pharmacovigilance databases with inherent reporting bias.","value_numeric":null}],"summaries":{"what_studied":"A PRISMA-compliant systematic literature review (search date May 2026) evaluated the reproductive safety of IL-12/23, IL-17, and IL-23 inhibitors during pregnancy and with paternal exposure in patients with psoriasis, examining pregnancy and neonatal outcomes across all available study designs.","key_result":"49 publications met inclusion criteria, reporting 5,962 pregnancies with maternal exposure; ustekinumab had the most data (2,933 pregnancies), followed by secukinumab (1,877), risankizumab (589), ixekizumab (296), guselkumab (217), tildrakizumab (32), bimekizumab (11), brodalumab (6), and mirikizumab (1). Cohort-level findings were generally reassuring — no consistent signal for adverse pregnancy or neonatal outcomes — except one study reporting increased risk of small-for-gestational-age infants with ustekinumab. Paternal exposure data were very limited (3 studies, 281 pregnancies).","limitations":"- Most exposures (n=5,074) came from pharmacovigilance databases that capture only adverse events, making incidence rates incalculable and meta-analysis infeasible.\n- Critical confounders (disease activity, exposure timing, comedications) were missing or unreported in the majority of studies; only one study used confounder-adjusted analysis.\n- Data were heavily skewed toward IBD patients, limiting psoriasis-specific and IL-17-specific conclusions.","practice_takeaway":"Available data are broadly reassuring but insufficient to issue definitive safety guidance; clinicians should weigh uncontrolled disease risk against medication uncertainty on a case-by-case basis. Existing psoriasis registries (e.g., BADBIR, BioCAPTURE) should add standardized pregnancy datasets to accelerate evidence generation."}},{"doi":"10.1007/s13555-026-01809-8","pmid":"42262459","title":"New Tuberculosis Infection and Reactivation of Tuberculosis in Patients with Psoriasis or Psoriatic Arthritis Receiving IL-23 Inhibitors: A Systematic Literature Review","journal_title":"Dermatology and Therapy","journal_issn":"2193-8210","published_at":"2026-06-09T00:00:00.000Z","url":"https://doi.org/10.1007/s13555-026-01809-8","source_score":2,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-06-15T13:21:49.802Z","updated_at":"2026-06-15T13:21:49.802Z","tags":[{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"brand","value":"Ilumya","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"brand","value":"Skyrizi","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"brand","value":"Tremfya","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"category","value":"Dermatology","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"condition","value":"Latent Tuberculosis Infection","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"condition","value":"Psoriasis","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"condition","value":"Psoriatic Arthritis","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"generic","value":"guselkumab","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"generic","value":"risankizumab","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"generic","value":"tildrakizumab","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"modality","value":"IL-23 Inhibitor","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"sample_size","value":"n=41","value_numeric":41},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"study_design","value":"Systematic Literature Review","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"warning","value":"Sample size tag reflects number of studies (41), not individual patients, as total patient-level N was not reported in the abstract.","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"warning","value":"The 'impact_flag' of practice_changing is applied cautiously — the review's conclusion that routine LTBI screening may not be required contradicts current guidelines for many biologics, and this is based on indirect/safety-as-secondary evidence rather than dedicated TB-outcome trials.","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"warning","value":"The review included case series and observational studies alongside RCTs; study quality is heterogeneous (assessed via RoB2 and NOS tools).","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01809-8","tag_type":"warning","value":"The single LTBI reactivation event in a risankizumab-treated patient was reported in one observational study; the abstract does not provide clinical details (e.g., TB prophylaxis status, country), limiting interpretation.","value_numeric":null}],"summaries":{"what_studied":"This systematic literature review evaluated the risk of latent TB infection (LTBI) reactivation and new TB infections in adults with psoriasis (PsO) or psoriatic arthritis (PsA) treated with IL-23 inhibitors (guselkumab, risankizumab, tildrakizumab), with a focus on the Asia-Pacific (APAC) region; 58 publications from 41 studies were included.","key_result":"No LTBI reactivation or new TB cases were observed in 33 of 34 PsO studies and all 8 PsA studies; only one observational study reported a single LTBI reactivation event in a risankizumab-treated PsO patient, including among patients with LTBI who did not complete chemoprophylaxis.","limitations":"- Most included studies were not designed with TB as a primary endpoint, limiting detection sensitivity.\n- Heterogeneous LTBI screening practices across studies and regions reduce comparability.\n- APAC-specific data came from only 9 publications across 8 studies, limiting conclusions for high-TB-burden settings.","practice_takeaway":"IL-23 inhibitors appear to carry minimal TB risk in patients with PsO or PsA, including those with LTBI who have not completed chemoprophylaxis. Routine pre-treatment LTBI screening before starting IL-23 inhibitor therapy may not be necessary, particularly in low-TB-prevalence regions."}},{"doi":"10.1002/art.70152","pmid":"41878957","title":"Combination Therapy in Participants With Active Psoriatic Arthritis Using Subcutaneous Guselkumab and Golimumab: Week 24 Results From a Phase 2a, Multicenter, Randomized, Double‐Blind, Proof‐of‐Concept Study","journal_title":"Arthritis & Rheumatology","journal_issn":"2326-5191","published_at":"2026-05-11T00:00:00.000Z","url":"https://doi.org/10.1002/art.70152","source_score":4,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-05-19T13:22:45.777Z","updated_at":"2026-05-19T13:22:45.777Z","tags":[{"paper_doi":"10.1002/art.70152","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1002/art.70152","tag_type":"brand","value":"Simponi","value_numeric":null},{"paper_doi":"10.1002/art.70152","tag_type":"brand","value":"Tremfya","value_numeric":null},{"paper_doi":"10.1002/art.70152","tag_type":"category","value":"Rheumatology","value_numeric":null},{"paper_doi":"10.1002/art.70152","tag_type":"condition","value":"Psoriatic Arthritis","value_numeric":null},{"paper_doi":"10.1002/art.70152","tag_type":"generic","value":"golimumab","value_numeric":null},{"paper_doi":"10.1002/art.70152","tag_type":"generic","value":"guselkumab","value_numeric":null},{"paper_doi":"10.1002/art.70152","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1002/art.70152","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1002/art.70152","tag_type":"modality","value":"IL-23 Inhibitor","value_numeric":null},{"paper_doi":"10.1002/art.70152","tag_type":"modality","value":"TNF Inhibitor","value_numeric":null},{"paper_doi":"10.1002/art.70152","tag_type":"sample_size","value":"n=91","value_numeric":91},{"paper_doi":"10.1002/art.70152","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1002/art.70152","tag_type":"study_design","value":"Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.1002/art.70152","tag_type":"warning","value":"ACR50 and MDA p-values in the CRP subgroup are nominal (not adjusted for multiplicity), increasing the risk of false-positive findings.","value_numeric":null},{"paper_doi":"10.1002/art.70152","tag_type":"warning","value":"A protocol deviation allowed enrollment of patients regardless of CRP level, creating a mixed population that diluted the intended treatment effect.","value_numeric":null},{"paper_doi":"10.1002/art.70152","tag_type":"warning","value":"Brand name 'Tremfya' noted for guselkumab; the paper does not specify which brand name was used in the trial context.","value_numeric":null},{"paper_doi":"10.1002/art.70152","tag_type":"warning","value":"Primary endpoint was not met in the overall population; positive signals in the CRP ≥0.3 mg/dL subgroup are from an exploratory/post-hoc analysis and should be interpreted cautiously.","value_numeric":null}],"summaries":{"what_studied":"This phase 2a RCT evaluated subcutaneous guselkumab (100 mg) + golimumab (50 mg) combination therapy vs. guselkumab monotherapy (both every 4 weeks through week 20) in adults with active TNFi-inadequate response PsA (≥3 tender/swollen joints), with a primary endpoint of week 24 minimal disease activity (MDA).","key_result":"The primary endpoint was not met: MDA at week 24 was 29% (combo) vs. 22% (mono), OR 1.4 [90% CI 0.6–3.3], P=0.557. However, in the intended subgroup with CRP ≥0.3 mg/dL (n=40 combo, n=22 mono), combination therapy showed markedly better MDA (32% vs. 5%, OR 12.3, nominal P=0.025) and ACR50 (55% vs. 14%, OR 9.6, nominal P=0.003). No new safety signals, tuberculosis, or opportunistic infections occurred through week 36.","limitations":"- Primary endpoint missed in the overall population, partly due to a protocol deviation that enrolled patients regardless of CRP level (diluting the intended high-inflammation cohort).\n- Small sample size (n=91 total) and 2:1 randomization limit statistical power.\n- Phase 2a proof-of-concept design; results are hypothesis-generating and not confirmatory.","practice_takeaway":"For TNFi-inadequate responders with active PsA and elevated CRP (≥0.3 mg/dL), the guselkumab + golimumab dual-biologic combination showed clinically meaningful ACR50 and MDA signals worth monitoring in future trials. This combination should not yet be adopted in routine practice, but clinicians may watch for phase 3 data in this CRP-elevated subgroup."}},{"doi":"10.14309/ajg.0000000000004041","pmid":"42065421","title":"Efficacy and Safety of Guselkumab for Ulcerative Colitis Through Week 92 of the QUASAR Long-Term Extension Study","journal_title":"American Journal of Gastroenterology","journal_issn":"0002-9270","published_at":"2026-05-01T00:00:00.000Z","url":"https://doi.org/10.14309/ajg.0000000000004041","source_score":7,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-05-08T13:23:58.836Z","updated_at":"2026-05-08T13:23:58.836Z","tags":[{"paper_doi":"10.14309/ajg.0000000000004041","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.14309/ajg.0000000000004041","tag_type":"brand","value":"Tremfya","value_numeric":null},{"paper_doi":"10.14309/ajg.0000000000004041","tag_type":"category","value":"Gastroenterology & Hepatology","value_numeric":null},{"paper_doi":"10.14309/ajg.0000000000004041","tag_type":"condition","value":"Ulcerative Colitis","value_numeric":null},{"paper_doi":"10.14309/ajg.0000000000004041","tag_type":"generic","value":"guselkumab","value_numeric":null},{"paper_doi":"10.14309/ajg.0000000000004041","tag_type":"impact_flag","value":"confirms_prior","value_numeric":null},{"paper_doi":"10.14309/ajg.0000000000004041","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.14309/ajg.0000000000004041","tag_type":"modality","value":"IL-23 Inhibitor","value_numeric":null},{"paper_doi":"10.14309/ajg.0000000000004041","tag_type":"sample_size","value":"n=303","value_numeric":303},{"paper_doi":"10.14309/ajg.0000000000004041","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.14309/ajg.0000000000004041","tag_type":"study_design","value":"Long-Term Extension Study","value_numeric":null},{"paper_doi":"10.14309/ajg.0000000000004041","tag_type":"warning","value":"Level of evidence rated 2 based on the randomized maintenance phase design; the LTE itself is an open-label extension without a concurrent placebo arm.","value_numeric":null},{"paper_doi":"10.14309/ajg.0000000000004041","tag_type":"warning","value":"Sample size of n=303 reflects participants without dose adjustment; the LTE enrolled 329 total — the smaller cohort was used for efficacy analysis.","value_numeric":null},{"paper_doi":"10.14309/ajg.0000000000004041","tag_type":"warning","value":"The full text provided is a Lippincott permissions document, not the actual manuscript body; all clinical data were extracted from the abstract and results sections only.","value_numeric":null}],"summaries":{"what_studied":"Evaluated the efficacy and safety of subcutaneous guselkumab (100 mg q8w or 200 mg q4w) through week 92 of the QUASAR long-term extension (LTE) in adults with ulcerative colitis who were intravenous guselkumab induction responders and completed the week M-44 maintenance visit.","key_result":"At week M-92, clinical remission was achieved by 71% (110/155) on guselkumab 100 mg q8w and 74% (109/148) on 200 mg q4w (nonresponder imputation); as-observed rates were 75% and 83%, respectively. Nearly 100% (218/219) of patients in remission were corticosteroid-free for ≥8 weeks prior. 95% (287/303) completed treatment through week M-92.","limitations":"No placebo comparator in the LTE (placebo arm discontinued at week M-44 unblinding). Study is ongoing, so full long-term safety data are not yet complete. LTE enrolled only prior induction responders, limiting generalizability to the broader UC population.","practice_takeaway":"Guselkumab maintained durable, corticosteroid-free remission in roughly 70–83% of UC patients through 2 years of maintenance therapy. 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By NRI analysis of all randomized participants (n=176/185), clinical remission was 46.0% and endoscopic remission rates were similarly durable. Responses were consistent across biologic-naive and biologic-inadequate-response subgroups (~97% clinical remission, ~54% endoscopic remission in both). Serious adverse events, serious infections, and discontinuations due to adverse events remained low throughout.","limitations":"Phase 2 trial only — not powered for statistical comparisons between dose groups or vs. placebo at 5 years. As-observed analysis is subject to attrition bias (only 87 of 185 randomized participants had data at week 240). No active comparator arm for long-term assessment.","practice_takeaway":"Guselkumab shows durable clinical and endoscopic efficacy through 5 years in Crohn's disease, with a favorable long-term safety profile — results that support its potential as a sustained maintenance option pending phase 3 confirmation. 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