Comparative Efficacy Of Biologics Research Articles

Comparative Efficacy of Biologics and Small Molecule in Ulcerative Colitis: A Systematic Review and Network Meta-analysis

Background & aimsTreatment options for moderate to severe ulcerative colitis (UC) are increasing rapidly, but the lack of comparative efficacy trials makes treatment choices a clinical challenge. This network-meta-analysis aimed to compare the relative efficacy of biologics and small molecules in achieving remission in patients with moderate to severe UC. MethodsThe literature was searched up to May 2024. Phase 3 placebo or active comparator randomized controlled trials (RCTs) were included. The primary outcome was induction and maintenance of endoscopic improvement (Mayo endoscopic score [MES] ≤1). Secondary outcomes were the induction and maintenance of clinical remission, endoscopic (MES = 0) and histological remission. A sub-analysis was performed based on the RCT design and previous exposure to biologic therapy. ResultsWe identified 36 studies that met our inclusion criteria, with 14,270 patients with UC. Upadacitinib ranked highest in inducing clinical remission (99.6%), and endoscopic improvement (99.2%), followed by risankizumab (91.4%) and (82.3%) respectively. In maintenance of endoscopic improvement, upadacitinib ranked first (98.6%) followed by filgotinib 200 mg (79.2%). Risankizumab ranked first in the induction of histological remission (89.4%). Followed by guselkumab (88.3%). Upadacitinib ranked first (93.1%) in maintaining histological remission followed by guselkumab (89.5%). ConclusionUpadacitinib appears to be superior to other therapies in achieving clinical remission, endoscopic improvement and remission, and histological remission. Furthermore, novel biologics such as risankizumab and guselkumab ranked high in achieving these outcomes. This study highlights the efficacy of small molecule drugs and novel selective IL-23s as alternatives to other biologics.

Comparative Efficacy of Biologics and Small Molecule Therapies in Improving Patient-Reported Outcomes in Ulcerative Colitis: Systematic Review and Network Meta-Analysis

Abstract Background Ulcerative colitis (UC) is a chronic disorder with a considerable negative impact on health-related quality of life (HRQoL), which has been recently recognized as an important treatment target. The purpose of this study is to compare the efficacy of different biologics and small molecule therapies in achieving better patient-reported outcomes and HRQoL in patients with UC. Methods We performed a systematic review and network meta-analysis of the EMBASE, MEDLINE, and Cochrane Central databases from inception until February 1, 2024. The primary endpoint was clinical remission in the patient-reported outcome (PRO-2) score in UC patients who were treated with different biologics or small molecules during induction and maintenance phases. PRO-2 score is the sum of both stool frequency and rectal bleeding subscores. The secondary outcome was improvement of HRQoL defined as an increase in Inflammatory Bowel Disease Questionnaire score of ≥16 points from baseline or any change in total score from baseline. A random effects model was used, and outcomes were reported as odds ratio with 95% confidence interval. Interventions were ranked per the SUCRA (surface under the cumulative ranking curve) score. Results A total of 54 studies were included in the primary outcome analysis and 15 studies were included in the secondary outcome analysis. The primary analysis showed that during the induction phase all of included drugs were better than placebo in improving the PRO-2 score. Interestingly, upadacitinib was found to be superior to most medications in improving PRO-2 scores. The secondary analysis showed that guselkumab ranked first in the improvement of the Inflammatory Bowel Disease Questionnaire score, followed by upadacitinib during the induction phase. Conclusion Upadacitinib ranked first in PRO-2 clinical remission during the induction and maintenance phases. Guselkumab, mirikizumab, tofacitinib, and upadacitinib were the only novel medications that were superior to placebo in improving HRQoL in UC, with guselkumab ranking the highest, followed by tofacitinib and upadacitinib. During maintenance of remission, tofacitinib ranked highest in improving HRQoL.

Comparative efficacy of biologics and oral agents in palmoplantar psoriasis and palmoplantar pustulosis: A systematic review and network meta-analysis of randomized clinical trials

Comparative efficacy of biologics and oral agents in palmoplantar psoriasis and palmoplantar pustulosis: A systematic review and network meta-analysis of randomized clinical trials

Sa1257 Comparative Efficacy of Biologics in the Treatment of Moderately to Severely Active Ulcerative Colitis (UC): A Systematic Review and Network Meta-Analysis

Background: This study aimed to assess the comparative efficacy and safety of biologics in adult patients with moderately to severely active UC, stratified by prior exposure to antiTNF inhibitors. Methods: MEDLINE, Embase, The Cochrane Library, and ClinicalTrials.gov were systematically searched using a predefined search strategy, without language restrictions, for studies of approved biologics for UC (adalimumab, golimumab, infliximab, vedolizumab) published before February 2014. Two reviewers independently assessed studies for inclusion using a 2-step process; data on study design, patient characteristics, and outcomes were extracted from 8 RCTs (GEMINI I, ULTRA-1, ULTRA-2, ACT-1, ACT-2, PURSUIT-SC, PURSUIT-M, Suzuki et al. [2014] J Gasteronenterol, 49(2):283-94) that met the inclusion criteria and were suitable for network meta-analysis (NMA). The NMA was conducted for key endpoints at induction and maintenance, where data were available, in R and OpenBUGS using Bayesian fixed effects mixed treatment comparisons. Assumptions were made to account for differences in maintenance study design. Results: Seven studies were included in the analysis of induction treatment for anti-TNF-naive patients. All biologics were more effective than placebo in terms of response, remission, and mucosal healing, but rankograms suggested no significant differences between the included biologics. These results were consistent with recent reports (Danese et al. [2014] Ann Intern Med, 160(10):704-11). Five studies were included in the analysis of maintenance treatment for anti-TNF-naive patients. Vedolizumab every 8 weeks (Q8W) resulted in improved results versus comparators for all outcomes at week 52 and was associated with a significantly higher rate of durable clinical response than all comparators (Table 1). In patients who had previously received anti-TNFs, only vedolizumab and adalimumab could be compared. At induction, no significant differences in efficacy were observed between the 2 biologics. During maintenance treatment, vedolizumab resulted in improved rates of durable response and remission and significantly improved rates of mucosal healing compared with adalimumab (Table 1). Conclusion: This study adds to the current understanding of the comparative efficacy and safety of biologic treatment for UC, encompassing outcomes and populations not included in previous studies. All biologic treatments are effective in the treatment of UC, with vedolizumab demonstrating benefits compared with all comparators irrespective of prior anti-TNF exposure in the maintenance setting.

P554. Comparative efficacy of biologics in the treatment of moderately to severely active ulcerative colitis (UC): A systematic review and network meta-analysis

P554. Comparative efficacy of biologics in the treatment of moderately to severely active ulcerative colitis (UC): A systematic review and network meta-analysis

Comparative efficacy of biologics as monotherapy and in combination with methotrexate on patient reported outcomes (PROs) in rheumatoid arthritis patients with an inadequate response to conventional DMARDs--a systematic review and network meta-analysis.

ObjectiveTo compare biologics as monotherapy or in combination with methotrexate (MTX) in terms of patient reported outcomes (PROs) in RA patients with an inadequate response to conventional DMARDs (DMARD-IR).MethodsWith a systematic literature review 17 RCTs were identified that evaluated adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, abatacept, anakinra or tocilizumab. Treatment effects in terms of pain (0-100 mm), patient’s global assessment of disease activity (PGA; 0-100 mm), Health Assessment-Questionnaire (HAQ) disability index (DI; 0–3), and the physical component summary (PCS) of the SF36 Health Survey (0–100) at 24 weeks were combined by means of Bayesian network meta-analyses.ResultsWith tocilizumab monotherapy, greater improvements in pain (difference = -11.1; (95% Credible Interval -21.3, -0.1)) and PGA (-10.3 (-20.4, 0.8)) were observed than with aTNF monotherapy. Tocilizumab was at least as efficacious as aTNF in HAQ-DI improvements (-0.16; (-0.37, 0.05)). aTNF + MTX (-17.9 (-23.1, -13.0) & -19.1 (-24.2, -14.4)), abatacept + MTX (-23.0 (-47.3, 1. 5) & -13.6 (-28.4, 2.0)) and tocilizumab + MTX (-16.0 (-26.3, -6.3) & -15.1 (-25.1, -5.7)) showed comparable reductions in pain and PGA relative to MTX. Efficacy of anakinra + MTX was much smaller as compared to other biologics. The greatest improvements in HAQ-DI relative to MTX were observed with aTNF + MTX (-0.30 (-0.37, -0.22)) and tocilizumab + MTX (-0.27 (-0.42, -0.12)), followed by abatacept + MTX (-0.21 (-0.37, -0.05)) and anakinra + MTX (-0.11 (-0.26, 0.05)). The improvements in SF36-PCS with abatacept + MTX, aTNF + MTX and tocilizumab + MTX were comparable. There is a >90% probability that aTNF + MTX results in a greater improvement in pain (-12.4), PGA (-16.1) and HAQ-DI (-0.21) than aTNF as monotherapy. Efficacy of tocilizumab + MTX showed comparable improvements in PROs as tocilizumab monotherapy.ConclusionsBased on a network meta-analysis involving indirect comparison of trial findings, the following observations were made for DMARD-IR patients. In monotherapy, tocilizumab was associated with a greater improvement in pain and self-reported disease activity than aTNF, and was at least as efficacious regarding functional ability. The improvements in PROs with aTNF, abatacept and tocilizumab in combination with MTX were comparable. Improvements in PROs with tocilizumab as monotherapy were similar to that of tocilizumab + MTX, whereas aTNF as monotherapy was likely to be less efficacious than aTNF + MTX.