In the JournalsPerspective

Efficacy of anti-TNFs similar in postoperative Crohn’s recurrence

Humira and Remicade are both equally effective for treating postoperative recurrence of Crohn’s disease, according to data from clinical practice.

Eugeni Domènech, MD, PhD, of the department of gastroenterology at Hospital Universitari Germans Trias i Pujol in Badalona, Spain, and colleagues wrote in Inflammatory Bowel Diseases that there have been very few randomized controlled trials that have explored the efficacy of these drugs in postoperative recurrence (POR) of CD, and design of the trials do not reflect the ways anti-TNFs are used in the real world.

“Additional information on anti-TNF efficacy for preventing POR is limited, and it includes some small retrospective series or prospective studies, demonstrating the need for real-life data in this scenario,” they wrote. “There is also lack of comparative data for preventive efficacy of the currently available anti-TNF agents, and only a network meta-analysis of prospective trials that did not include the largest RCT with adalimumab [Humira; AbbVie] has been published recently.”

Domènech and colleagues wanted to use real-world, clinical data to assess the efficacy of adalimumab and Remicade (infliximab, Janssen) at preventing early POR in CD, as well as the associated risk factors for POR.

Using the ENEIDA registry — a prospectively maintained database of patients with IBD started in 2006 — researchers identified patients who had been prescribed adalimumab or infliximab within 3 months after ileocolonic resection and had endoscopic assessment within 18 months of surgery.

Of 152 patients in the study, 55 were treated with infliximab and 97 were treated with adalimumab. Additionally, 82% had been exposed to anti-TNF prior to surgery, and 39% were on concomitant immunosuppressant therapy.

After 18 months following surgery, data showed that 34% of patients had endoscopic POR (defined as a Rutgeerts endoscopic score > i1), 14% had advanced endoscopic POR (> i2) and 20% had clinical POR. They found no differences in efficacy between adalimumab and infliximab.

In their analysis, investigators found that perianal disease (OR = 2.73, 95% CI, 1.26–5.91) and rectal involvement (OR = 2.79, 95% CI, 1.09–7.14) were both independent risk factors of endoscopic POR.

Domènech and colleagues wrote that their findings show that anti-TNFs helped most patients avoid early recurrence and advanced lesions after surgery. They also back up previous limited evidence that supported using either adalimumab or infliximab as first-line prevention of POR.

“The concomitant use of immunosuppressants or an initial short course of metronidazole does not seem to increase their efficacy in the medium term,” they wrote. “Patients with a history of perianal disease and those with rectal involvement are at higher risk of developing endoscopic POR despite anti-TNF therapy for prevention.” – by Alex Young

Disclosures: Domènech reports serving as a speaker, receiving research or educational support from AbbVie, Adacyte Therapeutics, Celgene, Ferring, Gerbo, Grifols, Janssen, Kern Pharma, MSD, Otsuka Pharmaceuticals, Pfizer, Shire, Takeda, Thermofisher and Tillots. Please see the full study for all other authors’ relevant financial disclosures.

 

Humira and Remicade are both equally effective for treating postoperative recurrence of Crohn’s disease, according to data from clinical practice.

Eugeni Domènech, MD, PhD, of the department of gastroenterology at Hospital Universitari Germans Trias i Pujol in Badalona, Spain, and colleagues wrote in Inflammatory Bowel Diseases that there have been very few randomized controlled trials that have explored the efficacy of these drugs in postoperative recurrence (POR) of CD, and design of the trials do not reflect the ways anti-TNFs are used in the real world.

“Additional information on anti-TNF efficacy for preventing POR is limited, and it includes some small retrospective series or prospective studies, demonstrating the need for real-life data in this scenario,” they wrote. “There is also lack of comparative data for preventive efficacy of the currently available anti-TNF agents, and only a network meta-analysis of prospective trials that did not include the largest RCT with adalimumab [Humira; AbbVie] has been published recently.”

Domènech and colleagues wanted to use real-world, clinical data to assess the efficacy of adalimumab and Remicade (infliximab, Janssen) at preventing early POR in CD, as well as the associated risk factors for POR.

Using the ENEIDA registry — a prospectively maintained database of patients with IBD started in 2006 — researchers identified patients who had been prescribed adalimumab or infliximab within 3 months after ileocolonic resection and had endoscopic assessment within 18 months of surgery.

Of 152 patients in the study, 55 were treated with infliximab and 97 were treated with adalimumab. Additionally, 82% had been exposed to anti-TNF prior to surgery, and 39% were on concomitant immunosuppressant therapy.

After 18 months following surgery, data showed that 34% of patients had endoscopic POR (defined as a Rutgeerts endoscopic score > i1), 14% had advanced endoscopic POR (> i2) and 20% had clinical POR. They found no differences in efficacy between adalimumab and infliximab.

In their analysis, investigators found that perianal disease (OR = 2.73, 95% CI, 1.26–5.91) and rectal involvement (OR = 2.79, 95% CI, 1.09–7.14) were both independent risk factors of endoscopic POR.

Domènech and colleagues wrote that their findings show that anti-TNFs helped most patients avoid early recurrence and advanced lesions after surgery. They also back up previous limited evidence that supported using either adalimumab or infliximab as first-line prevention of POR.

“The concomitant use of immunosuppressants or an initial short course of metronidazole does not seem to increase their efficacy in the medium term,” they wrote. “Patients with a history of perianal disease and those with rectal involvement are at higher risk of developing endoscopic POR despite anti-TNF therapy for prevention.” – by Alex Young

Disclosures: Domènech reports serving as a speaker, receiving research or educational support from AbbVie, Adacyte Therapeutics, Celgene, Ferring, Gerbo, Grifols, Janssen, Kern Pharma, MSD, Otsuka Pharmaceuticals, Pfizer, Shire, Takeda, Thermofisher and Tillots. Please see the full study for all other authors’ relevant financial disclosures.

 

    Perspective
    Miguel Regueiro

    Miguel Regueiro

    This is an interesting study from the Spanish group that reports a few important findings. The primary conclusion is that both adalimumab (Humira; AbbVie) and infliximab (Remicade; Janssen) work equally well to prevent postoperative Crohn’s disease. Additionally, the utility of antibiotics (metronidazole) and concomitant immunomodulators did not improve outcomes beyond monotherapy anti-TNF.

    It should be noted that this is not a comparative effective study and there are limitations in the methodology that may impact the outcomes. Despite this, the take home message is that in patients in the “deepest remission,” ie, having had the diseased bowel surgically removed, adalimumab and infliximab work equally well in preventing recurrent Crohn’s disease.

    • Miguel Regueiro, MD
    • Chair, department of gastroenterology, hepatology and nutrition
      Cleveland Clinic

    Disclosures: Regueiro reports research support from AbbVie, Janssen and Takeda; educational grants from AbbVie, Janssen, Pfizer, Salix, Shire, Takeda and UCD; and serves on advisory boards or consults for AbbVie, Amgen, Celgene, Janssen, Miraca Labs, Pfizer, Seres, Takeda and UCB.