Evolving Therapeutic Strategies in the Inflammatory Bowel Disease

Soo-Young Na; Won Moon

doi:10.4166/kjg.2018.71.2.61

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Na and Moon: Evolving Therapeutic Strategies in the Inflammatory Bowel Disease

Review Article

Korean J Gastroenterol 2018;71(2):61-68.

Published online: 4 October 2018

DOI: https://doi.org/10.4166/kjg.2018.71.2.61

Evolving Therapeutic Strategies in the Inflammatory Bowel Disease

Soo-Young Na, Won Moon¹

Department of Internal Medicine, Jeju National University School of Medicine, Jeju Korea

¹Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea

Correspondence to: Won Moon, Department of Internal Medicine, Kosin University College of Medicine, 262 Gamcheon-ro, Seo-gu, Busan 49267, Korea. Tel: +82-51-990-5207, Fax: +82-51-990-5055, E-mail: moonone70@hanmail.net

Received 22 January 2018 Revised 11 February 2018 Accepted 14 February 2018

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

It is important to have effective therapeutic strategies and goals in clinical practice and research of inflammatory bowel disease. Conventional end points for clinical trials in Crohn's disease and ulcerative colitis have been based on composite indices, such as the Crohn's Disease Activity Index and the Mayo Clinic Score. Although these indices have been shown to reduce the intestinal injury to some extent, satisfactory results have not been obtained in improving the quality of life of patients. Recently, alternative measures of outcome and definitions of response are being developed beyond symptoms. Mucosal healing as a clinical response and treatment goal has showed better long-term outcomes. Patient-reported outcomes (PROs) are emerging instrument directly created by patient to quantify symptoms. Coprimary realistic treatment ‘target', comprising mucosal healing and PROs, can offer a clinically valid endpoint and can be readily applied in practice compare to existing composite indices. ‘Treat-to-target' algorithm based on mucosal healing and PROs, in which therapy is progressively intensified until a specific personal treatment goal is reached, could improve quality of life of patient by reducing disease-related disability. Furthermore, histologic remission is an area of increased research focus and has the potential to guide treatment decisions in the future.

Keywords: Inflammatory bowel disease, Therapy, Mucosa, Patient reported outcome measures

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Fig. 1.

Concept of the treat-to-target.³¹

Fig. 2.

Treatment strategies and goals for inflammatory bowel disease over time. CI, composite index; MH, mucosal healing; PRO, patient-reported outcome; i-PRO, interim PRO; HR, histologic remission; T2T, treat-to-target; UC, ulcerative colitis.

Fig. 3.

Evolving concept of therapeutic “target” in inflammatory bowel disease. Sx, symptom; CI, composite index; MH, mucosal healing; PRO, patient-reported outcome, HR, histologic remission.

Table 1.

Crohn's Disease Activity Index (CDAI)⁴

Variable	Scale	Weight
Liquid or very soft stools	Stool count summed daily for 7 days	2
Abdominal pain	Sum of 7 days of daily ratings as:	5
	0=none, 1=mild, 2=moderate, 3=severe
General well-being	Sum of 7 days of daily ratings as:	7
	0=general well, 1=slightly below par, 2=poor, 3=very poor, 4=terrible
Features of extraintestinal disease	Any of the following present during the 7 days:	20 each
	a. Arthritis or arthralgia
	b. Skin or mouth lesions, including pyoderma gangrenosum, erythema nodosum, aphthous stomatitis
	c. Iritis or uveitis
	d. Anal fissure, fistula, or perianal abscess
	e. Other external fistula
	f. Fever>100℉
Opiates for diarrhea	0=no, 1=yes	30
Abdominal mass	0=none, 2=questionable, 5=definite	10
Hematocrit value	Males: 47– hematocrit	6
	Females: 42– hematocrit
% Body weight below standard	100×[1-(body weight/standard weight)]	1

CDAI (range, 0 to 600); <150, clinical remission; 150 to 219, mild actively disease; 220 to 450, moderate active disease; and >450, very severe disease. Clinical response was subsequently defined as a reduction from the baseline score of 70 to 100 points.

Table 2.

Mayo Clinic Score (MCS)⁷

Stool frequency
0	Normal
1	1–2 stools/day more than normal
2	3–4 stools/day more than normal
3	5 or more stools/day more than normal
Rectal bleeding
0	None
1	Visible blood with stool less than half the time
2	Visible blood with stool half of the time or more
3	Passing blood alone
Mucosal appearance at endoscopy
0	Normal or inactive disease
1	Mild disease (erythema, decreased vascular pattern, mild friability
2	Moderate disease (marked erythema, absent vascular pattern, friability, erosions
3	Severe disease (spontaneous bleeding, ulceration)
Physician rating of disease activity
0	Normal
1	Mild
2	Moderate
3	Severe

A score of 3 for bleeding required patients to have at least 50% of bowel motions accompanied by visible blood and at least one bowel motion with blood alone. MCS (range, 0 to 12); ≤2 and no subscore >1, clinical remission; 3 to 5, mild activity; 6 to 10, moderate activity; and 11 to 12, severe activity.

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