Dr. Dana Lukin: The most exciting developments in IBD treatment

Gastroenterologists provide care to many different kinds of patients, including those with chronic conditions. Inflammatory bowel disease is a key area of focus in GI, and new developments continue to roll out in the field.

Dana Lukin, MD, PhD, a gastroenterologist with Montefiore Health System and assistant professor of medicine at Albert Einstein College of Medicine in New York, shares his thoughts on the most exciting developments in IBD and what the future of the field may hold.

Question: What do you think are the most exciting developments in IBD treatment?
Dr. Dana Lukin: The number of medical options for patients with Crohn's disease and ulcerative colitis has been increasing in recent years with the approval of several new medications, including a delayed release budesonide formulation for use in mild to moderate UC and vedolizumab for the use in CD and UC. There are several very exciting developments on the horizon.  

The monoclonal antibody ustekinumab (Stelara), which is directed against the common p40 subunit of interleukins 12 and 23 has demonstrated significantly better efficacy than placebo at 22 weeks in phase IIb clinical trials (N=526) in Crohn’s disease (CERTIFI trial, Sandborn et al., NEJM 2012) among patients previously exposed to anti-TNF therapy. With the expected approval of this medication, which is currently approved for the treatment of psoriasis, patients will now have the option of biologic agents affecting three distinct cellular pathways (anti-TNF, anti-integrin, and anti-IL-12/23).

Another exciting development is the advancement of clinical trials involving oral biologic agents for the treatment of IBD. These include orally active anti-TNF agents, JAK inhibitors and antisense nucleotides. Tofacitinib, an oral selective Janus kinase (JAK) inhibitor affecting JAK1 and JAK3  was shown to be significantly more effective than placebo in inducing a clinical response and clinical remission at 8 weeks in a phase II clinical trial in 192 patients with moderate to severe UC (Sandborn et al., NEJM 2012). Another agent showing significant promise is the oral antisense oligonucleotide mongersen, which is directed against ileal and colonic SMAD7, a key inflammatory mediator in CD involved in activation of TGFβ. A phase II study in 166 patients with active CD demonstrated a remarkable efficacy of mongersen in inducing a clinical response and clinical remission as compared to placebo at 2 weeks (Monteleone et al., NEJM 2015). These agents will need to be tested in phase III studies.  Should they come to market, they will revolutionize the treatment of moderate to severe IBD, giving patients an option for oral medication rather than intravenous infusion or subcutaneous injection.
Q: What developments do you hope to see in the future of IBD care?

DL: The number of potential effective therapies has been increasing and there are many more agents in advanced clinical studies. While these therapies will greatly expand our treatment options, each new medication targets unique pathways in intestinal inflammation, and these agents may be more useful in certain subsets of patients.  Our current options for assessment of disease activity and selection of biologically active compounds utilize a limited arsenal of biomarkers, including the C-reactive protein and fecal calprotectin or lactoferrin, and genetic markers potentially affecting disease.  Currently, although many genes have been associated with IBD, the precise role in causality or disease phenotype has not been well elucidated. With the development of new drugs, it will be extremely useful to identify and validate novel noninvasive markers of disease activity to guide and inform treatment decisions in IBD. These include inflammatory biomarkers which may lead a provider to treat selectively with one drug class over another as well as potential genetic mutations or polymorphisms which may predispose patients towards a unique dominant inflammatory pathway or towards a response to a particular drug.  Such personalized, or precision, medicine will potentially offer patients carefully selected therapies with the highest likelihood of success and in the shortest interval possible, minimizing drug failures and hopefully disease progression.  

Another key element of successful outcomes in IBD is the use of a multidisciplinary approach to patient care. The development of IBD centers involves an organized collaboration between providers in several specialties, including gastroenterology, surgery, rheumatology, dermatology, ophthalmology, psychiatry, social work, and nutrition, among others, to coordinate care of patients with often complex, multisystemic inflammatory disease.  Such centers aim to provide high quality of care meeting quality metrics, provide patient education and support, ensure the timely and effective attention of patients' multisystemic medical issues, and treat a complex IBD referral population. These care models foster excellent patient care, offer patients access to clinical research trials and improve continuity of care and adherence to therapy.  In the era of accountable care, I would expect medical centers to promote the development of such IBD centers to invest in better short- and long-term outcomes for IBD patients.

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