A real life comparison of the effectiveness of adalimumab and golimumab in moderate-to-severe ulcerative colitis, supported by propensity score analysis

Renna, Sara; Mocciaro, Filippo; Ventimiglia, Marco; Orlando, R.; Macaluso, Fabio Salvatore; Cappello, Maria; Fries, Walter; Mendolaro, M.; Privitera, Antonino Carlo; Ferracane, Concetta; Pisana, V; Magnano, Antonio; Pluchino, Dario; Inserra, G.; Scarpulla, G.; Garufi, Serena; Carroccio, Antonio; Siringo, S.; Mitri, Roberto Di; Cottone, Mario; Orlando, Ambrogio

doi:10.1016/j.dld.2018.06.008

Cited by 18 publications

(23 citation statements)

References 21 publications

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“…Overall, we found that all these drugs perform better in a real-life setting as compared with the registration trials. As to the real-life data, a recent study conducted in Italy in 2018 by Renna et al [17] in UC patients, 118 treated with ADA and 79 treated with GOL, found results similar to ours. The authors showed that 78.8% of patients in ADA and 63.3% of patients in GOL achieved clinical response after 8 weeks of treatment, while 40.7% of patients in ADA and 25.3% of patients in GOL achieved steroid-free clinical remission.…”

Section: Discussionsupporting

confidence: 87%

“…At the end of follow-up, 25% (vs. 41.1% at week 8) of the patients achieved MH [16]. In contrast, we found that 79.6% of patients receiving ADA achieved clinical response, 59.7% of patients achieved steroid-free clinical remission, and 51.6% achieved endoscopic response, confirming that real-life studies often found better results that registration studies [17].…”

Section: Discussionsupporting

confidence: 75%

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Real-Life Comparison of Different Anti-TNF Biologic Therapies for Ulcerative Colitis Treatment: A Retrospective Cohort Study

Barberio

Zingone

Frazzoni

et al. 2020

Dig Dis

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Background: Head-to-head comparison studies evaluating the effectiveness and tolerability of anti-tumor necrosis factor (anti-TNF) drugs in inflammatory bowel disease patients are lacking. Aim: To compare the effectiveness and tolerability of anti-TNF-α drugs used in clinical practice in a cohort of patients with moderate-to-severe ulcerative colitis (UC). Methods: Retrospectively, 122 UC patients treated with infliximab (IFX) originator and biosimilar, adalimumab (ADA), and golimumab (GOL) were included. We performed an ITT analysis to evaluate clinical response and remission, steroid-free clinical remission, and endoscopy response according to the different time points of the follow-up. Baseline and post indErledigt ((Please, could you write "post induction" and remove "postinduction"?))uction predictor factors of these outcomes were evaluated using multivariate logistic regression models. Moreover, a propensity score-based weighting analysis was performed. Data were analyzed using R and STATA11 software. Results: The overall clinical response was 77% after induction, 81.4% at 30 weeks, and 76.9% at 52 weeks, while the steroid-free clinical remission was 39.7, 46, and 54.6%, respectively. After induction, a higher rate of treatment failure was observed in the GOL group. At the end of follow-up, lower rates of steroid-free clinical remission and clinical response were obtained by GOL. At week 52, endoscopic response was achieved by 46.5% of the population. Conclusions: Among the different anti-TNF treatments, moderate-to-severe UC seems to respond better to IFX and ADA, whereas GOL seems to be less effective, despite a similar good safety profile.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionsupporting

confidence: 75%

Real-Life Comparison of Different Anti-TNF Biologic Therapies for Ulcerative Colitis Treatment: A Retrospective Cohort Study

Barberio

Zingone

Frazzoni

et al. 2020

Dig Dis

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“…Therapeutic drug monitoring has achieved a central role in clinical management of biologic agents, because dose adjustments can improve outcome when there is primary failure or loss of response. Lower serum level of golimumab correlated with worse clinical and endoscopic efficacy in clinical studies 1,2 and real world [30][31][32][33] . However, normal values have not been clearly defined and these parameters are not used in routine clinical practice.…”

Section: Discussionmentioning

confidence: 87%

Real-life experience with 4 years of golimumab persistence in ulcerative colitis patients

Iborra

García-Morales

Rubio

et al. 2020

Sci Rep

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Golimumab has demonstrated its long-term efficacy and safety in ulcerative colitis in clinical trials, but no data of long-term persistence has been published from real world. To estimate long-term persistence of golimumab, as well as factors associated with longer persistence, in patients with ulcerative colitis in real life. Observational multicentre study including adult patients with ulcerative colitis treated with golimumab and with at least twelve months of follow-up. We included 190 patients, 105 (55.26%) naive to anti-TNF, with mean disease duration of 9.32 ± 8.09 years. Probability of persistence was 63%, 46%, 39% and 27% at 1, 2, 3 and 4 years, respectively. Persistence was lower in patients with primary failure to previous anti-TNF. Eighty-two (43.16%) patients needed dose intensification during follow-up, with a mean time until intensification of 8.03 ± 8.64 months. Dose intensification and lower disease duration predicted higher persistence with golimumab (p = 0.037 and p = 0.008, respectively). During a follow-up of 17.25 ± 15.83 months, 32 (16.5%) patients needed hospitalisation and 11 (6%) underwent colectomy. No unexpected adverse events were reported. Golimumab has demonstrated good persistence and safety profile for long treatment in ulcerative colitis patients.

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“…Finally, it is surprising to note that several Italian studies found that GOL failed to maintain the remission in a significant percentage of patients. In example, at week 52, Orlandini et al [18] and Renna et al [29] found a remission rate under GOL of 46-49%, and Barberio et al [21] found a remission rate of 38.7%. Moreover, Pugliese et al [23] found a remission rate of 22.5% at week 108.…”

Section: Discussionmentioning

confidence: 99%

“…Why this unfavorable result occurs remains therefore unknown, however, some speculative hypotheses can be made. Firstly, real-life data found that anti-TNF antibodies work less in UC, both originator or biosimilars [21,30,31]; secondly several studies found GOL less effective than adalimumab and infliximab in UC patients [21,29,32]; thirdly, Jung et al [33] found recently that, in UC, GOL initiators had a higher risk of non-persistence and switching than infliximab initiators, in particular when using corticosteroids. This last point could in part explain our results.…”

Section: Discussionmentioning

confidence: 99%

Long-term, Real-life, Observational Study in Treating Outpatient Ulcerative Colitis with Golimumab

Tursi

Mocci

Elisei

et al. 2021

JGLD

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Background and Aims: Several studies have found Golimumab (GOL) effective and safe in the short-term treatment of ulcerative colitis (UC), but few long-term data are currently available from real world. Our aim was to assess the long-term real-life efficacy and safety of GOL in managing UC outpatients in Italy. Methods: A retrospective multicenter study assessing consecutive UC outpatients treated with GOL for at least 3-month of follow-up was made. Primary endpoints were the induction and maintenance of remission in UC, defined as Mayo score ≤2. Several secondary endpoints, including clinical response, colectomy rate, steroid free remission and mucosal healing, were also assessed during the follow-up. Results: One hundred and seventy-eight patients were enrolled and followed up for a median (IQR) time of 9 (3-18) months (mean time follow-up: 33.1±13 months). Clinical remission was achieved in 57 (32.1%) patients: these patients continued with GOL, but only 6 patients (3.4%) were still under clinical remission with GOL at the 42nd month of follow-up. Clinical response occurred in 64 (36.4%) patients; colectomy was performed in 8 (7.8%) patients, all of them having primary failure. Steroid-free remission occurred in 23 (12.9%) patients, and mucosal healing was achieved in 29/89 (32.6%) patients. Adverse events occurred in 14 (7.9%) patients. Conclusions: Golimumab does not seem able to maintain long-term remission in UC in real life. The safety profile was good.

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A real life comparison of the effectiveness of adalimumab and golimumab in moderate-to-severe ulcerative colitis, supported by propensity score analysis

Cited by 18 publications

References 21 publications

Real-Life Comparison of Different Anti-TNF Biologic Therapies for Ulcerative Colitis Treatment: A Retrospective Cohort Study

Real-Life Comparison of Different Anti-TNF Biologic Therapies for Ulcerative Colitis Treatment: A Retrospective Cohort Study

Real-life experience with 4 years of golimumab persistence in ulcerative colitis patients

Long-term, Real-life, Observational Study in Treating Outpatient Ulcerative Colitis with Golimumab

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