Association of baseline C-reactive protein and prior anti-tumor necrosis factor therapy with need for weekly dosing during maintenance therapy with adalimumab in patients with moderate to severe Crohn’s disease

Sandborn, William J.; Colombel, J F; D’Haens, Geert R.; Plevy, Scott E.; Panés, Julián; Robinson, Anne; Pollack, Paul; Zhou, Qian; Castillo, Majin; Thakkar, Roopal

doi:10.1185/03007995.2013.779575

Cited by 21 publications

(11 citation statements)

References 21 publications

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“…This finding is consistent with a previously published report from CHARM that showed that patients who dose escalated were able to regain efficacy . A recently published analysis from CHARM suggested that weekly dosing may be associated with greater efficacy than every other week dosing in patients with elevated CRP who have lost response to treatment with a prior anti‐TNF agent …”

Section: Discussionsupporting

confidence: 91%

Adalimumab maintains remission of Crohn's disease after up to 4 years of treatment: data from CHARM and ADHERE

Panaccione

Colombel

Sandborn

et al. 2013

Aliment Pharmacol Ther

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103

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BackgroundTherapies that maintain remission for patients with Crohn's disease are essential. Stable remission rates have been demonstrated for up to 2 years in adalimumab-treated patients with moderately to severely active Crohn's disease enrolled in the CHARM and ADHERE clinical trials.AimTo present the long-term efficacy and safety of adalimumab therapy through 4 years of treatment.MethodsRemission (CDAI <150), response (CR-100) and corticosteroid-free remission over 4 years, and maintenance of these endpoints beyond 1 year were assessed in CHARM early responders randomised to adalimumab. Corticosteroid-free remission was also assessed in all adalimumab-randomised patients using corticosteroids at baseline. Fistula healing was assessed in adalimumab-randomised patients with fistula at baseline. As observed, last observation carried forward and a hybrid nonresponder imputation analysis for year 4 (hNRI) were used to report efficacy. Adverse events were reported for any patient receiving at least one dose of adalimumab.ResultsOf 329 early responders randomised to adalimumab induction therapy, at least 30% achieved remission (99/329) or CR-100 (116/329) at year 4 of treatment (hNRI). The majority of patients (54%) with remission at year 1 maintained this endpoint at year 4 (hNRI). At year 4, 16% of patients taking corticosteroids at baseline were in corticosteroid-free remission and 24% of patients with fistulae at baseline had healed fistulae. The incidence rates of adverse events remained stable over time.ConclusionsProlonged adalimumab therapy maintained clinical remission and response in patients with moderately to severely active Crohn's disease for up to 4 years. No increased risk of adverse events or new safety signals were identified with long-term maintenance therapy. (http://clinicaltrials.gov number: NCT00077779).

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Section: Discussionsupporting

confidence: 91%

Adalimumab maintains remission of Crohn's disease after up to 4 years of treatment: data from CHARM and ADHERE

Panaccione

Colombel

Sandborn

et al. 2013

Aliment Pharmacol Ther

Self Cite

103

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“…Although it is tempting to compare clinical trials of drugs with similar pharmacotherapy targets, baseline subject demographics must be controlled for in a comparative analysis. A correlation between baseline CRP levels and response to TNF blockers has been previously observed in ankylosing spondylitis (11) and Crohn's disease (12). Interestingly, one large observational study showed that increased CRP levels at baseline are sometimes associated with good treatment response and drug survival, that is, the length of time a drug is used before termination (6).…”

Section: Discussionmentioning

confidence: 73%

Analysis of Trial Data for Infliximab and Golimumab: Baseline C‐Reactive Protein Level and Prediction of Therapeutic Response in Patients With Psoriatic Arthritis

Ramírez-Fort

Gottlieb

2014

Arthritis Care & Research

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Objective. Anti-tumor necrosis factor medications have demonstrated good efficacy in treating psoriatic arthritis (PsA).Clinical responses at the primary end point in recent clinical trials of golimumab in PsA subjects yielded lower American College of Rheumatology 20% criteria for improvement (ACR20) responses than those seen in the Infliximab Multinational Psoriatic Arthritis Controlled Trial 2 infliximab study. However, baseline C-reactive protein (CRP) levels of PsA subjects enrolled in these trials differed significantly. We hypothesized that baseline CRP levels predict the observed differing clinical response rates at the primary end point. Methods. Combining the data from the infliximab and golimumab trials, we stratified the data by baseline CRP levels and then correlated these cohorts with response to treatment, specifically the Psoriasis Area and Severity Index and the ACR20, ACR50, and ACR70 responses. Results. The mean baseline CRP level in the infliximab trial was 1.9 mg/dl versus 1.4 mg/dl in the golimumab trial. Only 23% of golimumab subjects had a CRP level >1.7 mg/dl versus 35% of infliximab subjects (P ‫؍‬ 0.0023). All subjects with a CRP level >1.7 mg/dl at baseline achieved higher ACR20, ACR50, ACR70 response rates (56%, 36%, and 18%, respectively) at the primary end point of 14 weeks in the infliximab and golimumab clinical trials than any subjects with a CRP level <1.7 mg/dl (48%, 28%, and 13%, respectively [P ‫؍‬ 0.045, P ‫؍‬ 0.027, and P ‫؍‬ 0.089, respectively]).Conclusion. These results demonstrate that an increased baseline CRP level predicted improved therapeutic response at the primary end point for subjects treated with both golimumab and infliximab. To allow for comparison between future drug development studies and meta-analyses, baseline CRP levels should be factored into the multivariate analysis.

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“…The current retrospective cohort study confirms that CRP is an important factor in the individualised therapy of CD. While an elevated CRP has been shown to be a good predictor of response to adalimumab initiation, early CRP normalisation is associated with sustained clinical response . In a Belgian retrospective multi‐centre adalimumab cohort study, an elevated CRP was associated with a lower response to dose escalation to adalimumab every week, but was not predictive of subsequent dose de‐escalation .…”

Section: Discussionmentioning

confidence: 97%

Dose de‐escalation to adalimumab 40 mg every 3 weeks in patients with Crohn's disease – a nested case–control study

Steenbergen

Bian

Vermeire

et al. 2017

Aliment Pharmacol Ther

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Association of baseline C-reactive protein and prior anti-tumor necrosis factor therapy with need for weekly dosing during maintenance therapy with adalimumab in patients with moderate to severe Crohn’s disease

Abstract: These subgroup analyses suggest that in patients with moderately to severely active CD, weekly dosing may be most effective in the anti-TNF-experienced patients with elevated CRP at baseline.

Cited by 21 publications

References 21 publications

Adalimumab maintains remission of Crohn's disease after up to 4 years of treatment: data from CHARM and ADHERE

Adalimumab maintains remission of Crohn's disease after up to 4 years of treatment: data from CHARM and ADHERE

Analysis of Trial Data for Infliximab and Golimumab: Baseline C‐Reactive Protein Level and Prediction of Therapeutic Response in Patients With Psoriatic Arthritis

Dose de‐escalation to adalimumab 40 mg every 3 weeks in patients with Crohn's disease – a nested case–control study

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