Observational Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Oct 21, 2017; 23(39): 7139-7149
Published online Oct 21, 2017. doi: 10.3748/wjg.v23.i39.7139
Adalimumab efficacy in enteropathic spondyloarthritis: A 12-mo observational multidisciplinary study
Michele Maria Luchetti, Devis Benfaremo, Francesco Ciccia, Laura Bolognini, Monia Ciferri, Alessia Farinelli, Matteo Rossini, Piergiorgio Mosca, Giovanni Triolo, Armando Gabrielli
Michele Maria Luchetti, Devis Benfaremo, Monia Ciferri, Alessia Farinelli, Matteo Rossini, Armando Gabrielli, Dipartimento Scienze Cliniche e Molecolari, Clinica Medica, Università Politecnica delle Marche, Ancona 60126, Italy
Francesco Ciccia, Giovanni Triolo, Dipartimento Biomedico di Medicina Interna e Specialistica, Sezione di Reumatologia, Università degli Studi di Palermo, Palermo 90021, Italy
Laura Bolognini, Piergiorgio Mosca, Dipartimento Gastroenterologico e dei Trapianti, Polo Ospedaliero-Universitario “Umberto I-G.M. Lancisi- G. Salesi”, Ancona 60126, Italy
Author contributions: Luchetti MM and Benfaremo D contributed equally to this work; Luchetti MM, Benfaremo D and Ciccia F contributed to study conception and design, data analysis and interpretation, and writing of the article; Benfaremo D, Bolognini L, Ciferri M, Farinelli A, Rossini M and Mosca P contributed to data acquisition; Luchetti MM, Benfaremo D, Ciccia F, Triolo G and Gabrielli A contributed to editing, reviewing and final approval of article.
Institutional review board statement: The study was reviewed and approved by the Comitato Etico, Polo Ospedaliero-Universitaria “Umberto I-G.M. Lancisi-G. Salesi”, Ancona, Italy, according to the 2015 local and national procedural laws.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: There are no conflicts of interest to report.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Michele Maria Luchetti, MD, Dipartimento Scienze Cliniche e Molecolari, Clinica Medica, Università Politecnica delle Marche, Ancona 60126, Italy. m.luchetti@univpm.it
Telephone: +39-71-2206101 Fax: +39-71-2206103
Received: May 28, 2017
Peer-review started: April 1, 2017
First decision: June 5, 2017
Revised: July 6, 2017
Accepted: August 15, 2017
Article in press: August 15, 2017
Published online: October 21, 2017
Processing time: 206 Days and 11.9 Hours
Abstract
AIM

To report adalimumab (Ada) efficacy on articular-gastrointestinal disease and health-related quality of life (HRQoL) in patients with enteropathic spondyloarthritis (ES).

METHODS

A cohort of 52 patients with ES was evaluated in the departments of gastroenterology and internal medicine. At baseline, all patients underwent assessment by an integrated gastro-rheumatologic evaluation of articular and gastrointestinal activity, as well patient reported outcomes (PROs) of the HRQoL questionnaires. After this integrated evaluation and following a specific working flowchart, the Ada anti-tumor necrosis factor (TNF)-inhibitor was assigned to a cohort of 30 patients and its clinical efficacy was evaluated at baseline and after 6-mo and 12-mo treatment by the following tests: (1) Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP); Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI) and Bath Ankylosing Spondylitis Metrology Index (BASMI) for articular activity; (2) Inflammatory Bowel Disease Questionnaire (IBDQ), Crohn’s Disease Activity Index (CDAI) and partial Mayo (pMayo) score for gastrointestinal symptoms and activity; and (3) Health Assessment Questionnaire (HAQ), Patient Global Assessment (PGA) and Short Form-36 health survey (SF-36) questionnaires for PROs of the HRQoL.

RESULTS

Integrated evaluation and management of the patients affected by ES, carried out simultaneously by a gastroenterologist and a rheumatologist, allowed clinicians to choose the optimal therapeutic strategy. In a cohort of 30 ES patients affected by active articular and gastrointestinal disease, or axial active articular inflammation, Ada led to fast and sustained improvement of both articular and gastrointestinal disease activities. In fact, all the clinimetric evaluation tests exploring articular or gastrointestinal activity, as well as all the HRQoL scores, showed a significant improvement having been achieved at the earliest (6-mo) assessment. This important clinical improvement was maintained at the 12-mo follow-up. Importantly, global and gastrointestinal quality of life significantly correlated with articular disease activity, providing evidence to support that the integrated evaluation is the best option to manage patients with ES.

CONCLUSION

Ada treatment, upon multidisciplinary (gastro-rheumatologic) evaluation, significantly improves both articular and gastrointestinal inflammation, thereby improving the HRQoL in patients affected by ES.

Keywords: Clinimetric assessment; Patient reported outcomes; Inflammatory bowel diseases; Enteropathic spondyloarthritis; Tumor necrosis factor-inhibitors; Multidisciplinary evaluation

Core tip: Enteropathic spondyloarthritis (ES) is characterized by articular inflammation in patients with inflammatory bowel diseases, such as Crohn’s disease or ulcerative colitis. Correct management, especially covering both of the two clinical manifestations (gastro-rheumatologic), remains a challenge. In this study, we demonstrated that the integrated gastroenterological and rheumatologic evaluation of ES patients achieved the best therapeutic approach. In particular, we demonstrated that in a real-life cohort of ES patients, the tumor necrosis factor-inhibitor, adalimumab, led to fast and sustained improvement of articular and gastrointestinal inflammation, with a consequent improvement in the global and gastrointestinal quality of life.