Patients with Crohn's disease can often use less medication

Selected patients with Crohn's disease can safely reduce medication under the guidance of a physician. This is shown by a study conducted by Erasmus medical center and Radboud university medical center. The drug adalimumab, which controls intestinal inflammation in patients with Crohn's disease, works almost as well if taken less often. The results of the study were published in The Lancet Gastroenterology.

Patients with Crohn's disease have a chronically inflamed gut. The disease affects the small intestine, colon or both parts. Patients experience alternating periods of flare-ups and stable disease. Although there are good treatments available, a cure is not yet possible.

Inflammatory protein

Adalimumab is a drug that can effectively treat Crohn’s disease. This drug inhibits the inflammatory protein tumor necrosis factor (TNF), which plays an important role in intestinal inflammation. By attenuating intestinal inflammation, adalimumab reduces symptoms, such as diarrhea, abdominal pain or fatigue. 

Patients usually receive injections with 40 mg of adalimumab every two weeks. Using this dose, 85 to 90 percent of patients do not experience flare-ups. When they stop taking this drug, at least half experience a flare-up. Until now, it was not known what would happen if patients took less of the drug rather than stopping. 

On vacation

'Yet, for some of the patients it is desirable to reduce the amount of medication used', say principal investigators Dr. Janneke van der Woude (Erasmus MC) and Dr. Frank Hoentjen (Radboudumc). 'Examples include experienced side effects, or difficulty to bring the injections on vacation. Also, certain vaccinations cannot be given in combination with adalimumab. Patients therefore want to know whether they can reduce the drug dosing in safe manner.'

Most patients who received 40 mg of adalimumab every four weeks (instead of every two weeks) during the study responded well to it. Van der Woude: 'Overall, they did not experience more persistent flare-ups than with the usual administration interval. A small proportion of patients developed more symptoms, but these were quickly controlled upon returning to the conventional interval. Carefully selected patients can safely increase the dosing interval under supervision of their own physician.' The study was conducted in 174 patients who had stable disease activity for nine months before the study began.

´The study shows that less frequent injections have advantages. For example, patients who increase the dosing interval had fewer infections, possibly because their immune system is less suppressed. They also had less pain at the injection site. The psychological aspect is also very important. More frequent injections also remind patients of their chronic condition', says Hoentjen. 

Cost savings

Furthermore, reducing use of the drug saves costs, explains Hoentjen. ‘That is important in these times of quickly increasing health care costs.' In a follow-up study, the researchers want to calculate exactly how much costs are saved if patients use the drug less often. 

The study has been an almost nine-year long journey in which twenty hospitals participated. Van der Woude: ‘The patients who participated were all supervised by their own physicians. That makes the study unique. Because it was conducted in the regular clinical practice setting, we know that the results can be implemented in clinical practice.'

About the publication

This study was published in The Lancet Gastroenterology: Increased versus conventional adalimumab dose interval for patients with Crohn’s disease in stable remission (LADI): a pragmatic, open-label, non-inferiority, randomised controlled trial. Reinier C.A. van Linschoten, Fenna M. Jansen, Renske W.M. Pauwels, Lisa J.T. Smits, Femke Atsma, Wietske Kievit, Dirk J de Jong, Annemarie C. de Vries, Paul J. Boekema, Rachel L. West, Alexander G.L. Bodelier, Ingrid A.M. Gisbertz, Frank H.J. Wolfhagen, Tessa E.H. Römkens, Maurice W.M.D. Lutgens, Adriaan A. van Bodegraven, Bas Oldenburg, Marieke J. Pierik, Maurice G.V.M. Russel, Nanne K. de Boer, Rosalie C. Mallant-Hent, Pieter C.J. ter Borg, Andrea E. van der Meulen-de Jong, Jeroen M. Jansen, Sita V. Jansen, Adrianus C.I.T.L. Tan, C. Janneke van der Woude, Frank Hoentjen, on behalf of the LADI study group and the Dutch Initiative on Crohn and Colitis. DOI: 10.1016/S2468-1253(22)00434-4.

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