Chair of the Digestive Disease & Surgery Institute
Cleveland Clinic, Cleveland
One of our ongoing goals as clinicians is to drive toward the minimum amount of medicine necessary to keep patients healthy, without going so far that we forfeit use of a critical drug that is continuing to provide benefits. Finding that right balance is the aim of de-escalation studies, such as the SPARE study that I highlight this month.
In the SPARE trial, patients with Crohn’s disease who had experienced remission for more than six months were divided into three groups: those who continued treatment with the biologic infliximab plus an immunomodulator such as azathioprine or mercaptopurine; those who maintained infliximab only, abandoning the immunomodulator; and those who stopped taking infliximab but maintained the immunomodulator.
The researchers found that remission was maintained just as well in patients who took both drugs or only took infliximab, but relapse rates were higher among people in remission who stopped taking infliximab but maintained their immunomodulator. My takeaway is that, generally, in CD patients in remission, it’s advisable to continue the medications that are working. However, if we are to stop a medication, discontinuing the immunomodulator and continuing infliximab monotherapy is reasonable.
This month’s other study, of which I am a co-author, focuses on shared decision making with our patients, whether it’s about discussing the timing of a surgery, when to begin receiving a therapy or any other aspect of their care. The study’s senior author is Corey Seigel, MD, MS, of Dartmouth Hitchcock Medical Center, in Lebanon, N.H., who is a leader in shared decision making in our field.
Patients had received a CD diagnosis up to 15 years before their enrollment in the study and were eligible for therapy with a biologic or immunomodulator, which we considered to be an advanced therapy. Some patients received extensive decision support materials about the risks and benefits of undergoing such advanced therapy. Others received the recommendation for therapy without the extra decision support.
We found that patients who had received the decision support materials—which included a video and a three-year projection of their likely outcome after beginning therapy—were more likely to elect combination therapy than the others, who were not provided this information. The takeaway for me is that proactively engaging and educating our patients in a shared-decision approach may improve their uptake of therapies.
Sparing CD Medications
Gastroenterol Hepatol 2023;8[3]:215-227
The SPARE study included 207 adults with CD who had received combination therapy of infliximab plus an immunomodulator for at least eight months. Sixty-seven patients stayed on combination therapy, 71 stopped infliximab and 69 stopped their immunomodulator. The two-year relapse rates were 14% (95% CI, 4%-23%) in the combination group, 36% (95% CI, 24%-47%) in the infliximab withdrawal group and 10% (95% CI, 2%-18%) in the immunosuppressant withdrawal group. The hazard ratio was 3.45 (95% CI, 1.56-7.69; P=0.003) for the infliximab withdrawal group versus the combination group and 4.76 (95% CI, 1.92-11.11; P=0.0004) for the infliximab withdrawal group versus the immunomodulator withdrawal group.
Patient–Provider Shared Decision Making
Aliment Pharmacol Ther 2023;57[2]:205-214
This study enrolled 158 adults who had received a CD diagnosis up to 15 years earlier, who were eligible to receive biologics or immunomodulators or, if they chose, combination therapy. Ninety-nine participants received intensive education about the risks and benefits of combination therapy, while the other 59 participants received the option of combination therapy but no specific information about it. Participants who received the intensive education more frequently chose combination therapy (25% vs. 5% of controls; P<0.001), were less conflicted about their decision (P<0.05) and had greater trust in their provider (P<0.05).
—Compiled and written by Marcus A. Banks
This article is from the May 2023 print issue.