Adalimumab monotherapy and a combination with azathioprine for Crohn's disease: A prospective, randomized trial

Journal of Crohn's and Colitis

Volumn 10, Issue 11, 2016, Pages 1259-1266

  Matsumoto, Takayuki ^a   Motoya, Satoshi ^b   Watanabe, Kenji ^c   Hisamatsu, Tadakazu ^d,ab   Nakase, Hiroshi ^e   Yoshimura, Naoki ^f   Ishida, Tetsuya ^g   Kato, Shingo ^h,ao   Nakagawa, Tomoo ⁱ   Esaki, Motohiro ^j,v   Nagahori, Masakazu ^k   Matsui, Toshiyuki ^l,ba   Naito, Yuji ^m   Kanai, Takanori ⁿ   Suzuki, Yasuo ^o   Nojima, Masanori ^p   Watanabe, Mamoru ^k   Hibi, Toshifumi ^q   Andoh, Akira ^r   Ashida, Toshifumi ^s   Endo, Katsuya ^t   Endo, Yutaka ^u   Fujita, Hiroshi ^w   Fujiya, Mikihiro ^x   Haruma, Ken ^y   Hiraoka, Sakiko ^z   Hirata, Ichiro ^aa   Honda, Yutaka ^ac   Iijima, Hideki ^ad   Iizuka, Bunei ^ae   Ikeya, Kentaro ^af   Inoue, Takuya ^ag   Inoue, Shuji ^ah   Ishiguro, Yo ^ai   Ishihara, Shunji ^aj   Ito, Hiroaki ^ak   Iwakiri, Ryuichi ^al   Kagaya, Takashi ^am   Kashida, Hiroshi ^an   Kato, Jun ^ap   Katsurada, Takehiko ^aq   Kinjyo, Fukunori ^ar   Kobayashi, Kiyonori ^as   Kodama, Mayumi ^at   Kunisaki, Reiko ^au   Kurahara, Koichi ^av   Kurokami, Takafumi ^aw   Kyouwon, Lee ^ax   Matsuda, Koichiro ^ay   Matsueda, Kazuhiro ^az   Mitsuyama, Keiichi ^bb   Mizokami, Yuji ^bc   Nakamura, Shiro ^bd   Nomura, Masafumi ^be   Ogawa, Atsuhiro ^bf   Okazaki, Kazuichi ^bg   Otsuka, Kazuaki ^bh   Sakuraba, Hirotake ^bi   Saruta, Masayuki ^bj   Sasaki, Makoto ^bk   Shirai, Takayuki ^bl   Suga, Tomoaki ^bm   Sugimura, Kazuhito ^bn   Sugiyama, Toshiro ^bo   Takeshima, Fuminao ^bp   Tamaki, Hiroyuki ^bq   Tanaka, Shinji ^br   Tanida, Satoshi ^bs   Tominaga, Keiichi ^bt   Tomizawa, Taku ^bu   Yamamoto, Shojiro ^bv   Yamashita, Masaki ^bw   Yoshida, Atsushi ^bx   more..

^a IWATE MEDICAL UNIVERSITY   (Japan)

^b Sapporo Kosei General Hospital   (Japan)

^c OSAKA CITY GENERAL HOSPITAL   (Japan)

^d KYORIN UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^e KYOTO UNIVERSITY   (Japan)

^f Tokyo Yamate Medical Center   (Japan)

^g OITA RED CROSS HOSPITAL   (Japan)

^h SAITAMA MEDICAL UNIVERSITY   (Japan)

ⁱ CHIBA UNIVERSITY   (Japan)

^j KYUSHU UNIVERSITY   (Japan)

^k TOKYO MEDICAL AND DENTAL UNIVERSITY   (Japan)

^l Fukuoka University Chikushi Hospital   (Japan)

^m KYOTO PREFECTURAL UNIVERSITY OF MEDICINE   (Japan)

ⁿ KEIO UNIVERSITY   (Japan)

^o TOHO UNIVERSITY   (Japan)

^p UNIVERSITY OF TOKYO   (Japan)

^q KITASATO INSTITUTE HOSPITAL   (Japan)

^r SHIGA UNIVERSITY OF MEDICAL SCIENCE   (Japan)

^s Sapporo Higashi Tokushukai Hospital   (Japan)

^t TOHOKU UNIVERSITY   (Japan)

^u SHOWA UNIVERSITY FUJIGAOKA HOSPITAL   (Japan)

^v KYUSHU UNIVERSITY   (Japan)

^w KAGOSHIMA UNIVERSITY   (Japan)

^x ASAHIKAWA MEDICAL COLLEGE   (Japan)

^y KAWASAKI MEDICAL SCHOOL   (Japan)

^z OKAYAMA UNIVERSITY   (Japan)

^aa FUJITA HEALTH UNIVERSITY HOSPITAL   (Japan)

^ab KYORIN UNIVERSITY   (Japan)

^ac NIIGATA UNIVERSITY   (Japan)

^ad OSAKA UNIVERSITY   (Japan)

^ae TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

^af Hamamatsu South Hospital   (Japan)

^ag OSAKA MEDICAL COLLEGE   (Japan)

^ah National Hospital Organization Kochi National Hospital   (Japan)

^ai HIROSAKI NATIONAL HOSPITAL   (Japan)

^aj SHIMANE UNIVERSITY   (Japan)

^ak Kinshukai Infusion Clinic   (Japan)

^al SAGA UNIVERSITY   (Japan)

^am KANAZAWA UNIVERSITY   (Japan)

^an KINKI UNIVERSITY   (Japan)

^ao SAITAMA MEDICAL UNIVERSITY   (Japan)

^ap WAKAYAMA MEDICAL UNIVERSITY   (Japan)

^aq HOKKAIDO UNIVERSITY   (Japan)

^ar UNIVERSITY OF THE RYUKYUS   (Japan)

^as KITASATO UNIVERSITY   (Japan)

^at Miyazaki Medical Centre Hospital   (Japan)

^au YOKOHAMA CITY UNIVERSITY MEDICAL CENTER   (Japan)

^av MATSUYAMA RED CROSS HOSPITAL   (Japan)

^aw SHIZUOKA GENERAL HOSPITAL   (Japan)

^ax Moriguchi Keijinkai Hospital   (Japan)

^ay TOYAMA PREFECTURAL CENTRAL HOSPITAL   (Japan)

^az KURASHIKI CENTRAL HOSPITAL   (Japan)

^ba FUKUOKA UNIVERSITY   (Japan)

^bb KURUME UNIVERSITY   (Japan)

^bc UNIVERSITY OF TSUKUBA   (Japan)

^bd HYOGO COLLEGE OF MEDICINE   (Japan)

^be TEINE KEIJINKAI HOSPITAL   (Japan)

^bf Bell Land General Hospital   (Japan)

^bg KANSAI MEDICAL UNIVERSITY   (Japan)

^bh SHOWA UNIVERSITY NORTHERN YOKOHAMA HOSPITAL   (Japan)

^bi HIROSAKI UNIVERSITY   (Japan)

^bj JIKEI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^bk AICHI MEDICAL UNIVERSITY   (Japan)

^bl TOKAI UNIVERSITY HACHIOJI HOSPITAL   (Japan)

^bm SHINSHU UNIVERSITY   (Japan)

^bn NIIGATA CITY GENERAL HOSPITAL   (Japan)

^bo UNIVERSITY OF TOYAMA   (Japan)

^bp NAGASAKI UNIVERSITY   (Japan)

^bq TAKAMATSU RED CROSS HOSPITAL   (Japan)

^br HIROSHIMA UNIVERSITY   (Japan)

^bs NAGOYA CITY UNIVERSITY   (Japan)

^bt DOKKYO MEDICAL UNIVERSITY   (Japan)

^bu GUNMA UNIVERSITY   (Japan)

^bv UNIVERSITY OF MIYAZAKI   (Japan)

^bw ST MARIANNA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^bx Ofuna Central Hospital   (Japan)

more..

Author keywords

Anti TNF alpha antibody; Crohn's disease; Immunomodulator

Indexed keywords

ADALIMUMAB; AZATHIOPRINE; ANTIINFLAMMATORY AGENT; IMMUNOSUPPRESSIVE AGENT;

ADOLESCENT; ADULT; AGED; ALOPECIA; AORTITIS; APPENDICITIS; ARTICLE; CONTROLLED STUDY; CROHN DISEASE; CROHN DISEASE ACTIVITY INDEX; DRUG EFFICACY; DRUG SAFETY; EDEMA; FEMALE; FEVER; HUMAN; HYPERAMYLASEMIA; INTENTION TO TREAT ANALYSIS; LEUKOPENIA; LIVER INJURY; LYMPHADENOPATHY; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NAUSEA; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RASH; REMISSION; TREATMENT DURATION; TREATMENT OUTCOME; CLINICAL TRIAL; COMBINATION DRUG THERAPY; MIDDLE AGED; MULTICENTER STUDY; YOUNG ADULT;

ADALIMUMAB; ADOLESCENT; ADULT; AGED; ANTI-INFLAMMATORY AGENTS; AZATHIOPRINE; CROHN DISEASE; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

EID: 85012288687     PISSN: 18739946     EISSN: 18764479     Source Type: Journal    
DOI: 10.1093/ecco-jcc/jjw152     Document Type: Article

References (22)

1. Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med 2010;362: 1383-95.
2. Colombel JF, Sandborn WJ, Rutgeerts P, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease. The CHARM trial. Gastroenterology 2007;132:52-65.
3. Watanabe M, Hibi T, Lomax KG, et al. Adalimumab for the induction and maintenance of clinical remission in Japanese patients with Crohn's disease. J Crohns Colitis 2012;6:160-73.
4. Dulai PS, Siegel CA, Colombel JF, Sandborn WJ, Peyrin-Biroulet L. Systematic review. Monotherapy with anti-tumour necrosis factor a agents versus combination therapy with an immunosuppressive for IBD. Gut 2014;63:1843-53.
5. Reenaers C, Louis E, Belaiche J, Seidel L, Keshav S, Travis S. Does co-treatment with immunosuppressors improve outcome in patients with Crohn's disease treated with adalimumab? Aliment Pharmacol Ther 2012;36:1040-8.
6. Kestens C, van Oijen MG, Mulder CL, et al. Adalimumab and infliximab are equally effective for Crohn's disease in patients not previously treated with anti-tumor necrosis factor-a agents. Clin Gastroenterol Hepatol 2013;11:826-31.
7. Peters CP, Eshuis EJ, Toxopeüs FM, et al. Adalimumab for Crohn's disease: Long-term sustained benefit in a population-based cohort of 438 patients. J Crohns Colitis 2014;8:866-75.
8. Kiss LS, Szamosi T, Molnar T, et al. Early clinical remission and normalisation of CRP are the strongest predictors of efficacy, mucosal healing and dose escalation during the first year of adalimumab therapy in Crohn's disease. Aliment Pharmacol Ther 2011;34:911-22.
9. Ishida K, Inoue T, Fujiwara K, et al. Clinical effects of adalimumab treatment with concomitant azathioprine in Japanese Crohn's disease patients. World J Gastroenterol 2013;19:2676-82.
10. Best WR, Beckrel JM, Singleton JW, Kern F. Development of a Crohn's disease activity index. Gastroenterology 1976;70:439-44.
11. Kochi S, Matsumoto T, Esaki M, Jo Y, Iida M. Prediction of 6-thioguanine nucleotides levels in Japanese patients with inflammatory bowel disease during long-term thiopurine administration. Scand J Gastroenterol 2010;45:608-14.
12. Daperno M, D'Heans G, van Asshche G, et al. Development and validation of a new, simplified endoscopic activity score for Crohn's disease. The SES-CD. Gastrointest Endosc 2004;60:505-12.
13. Ferrante M, Noman M, Vermeire S. Evolution of endoscopic activity scores under placebo therapy in Crohn's disease. Gastroenterology 2010;138:s358.
14. Lennard L, Singleton HJ. High-performance liquid chromatographic assay of the methyl and nucleotide metabolites of 6-mercaptopurine. Quantification of red blood cell 6-thioguanine nucleotide, 6-thionosinic acid and 6-methylmercaptopurine metabolites in a single sample. J Chromatogr 1992;583:83-90.
15. Bartelds GM, Krieckaert CL, Nurmohamed MT, et al. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA 2011;305:1460-8.
16. Bartends GM, Wijbrandts CA, Nurmohamed MT, et al. Clinical response to adalimumab. Relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis 2007;66:921-6.
17. Kopylov U, Al-Taweel T, Yaghoobi M, et al. Adalimumab monotherapy versus combination therapy with immunomodulators in patients with Crohn's disease. A systematic review and meta-analysis. J Crohns Colitis 2014;8:1632-41.
18. Hibi T, Naganuma M, Kitahora T, Kinjo F, Shimoyama T. Low-dose azathioprine is effective and safe for maintenance of remission in patients with ulcerative colitis. J Gastroent.erol 2003;38:740-6.
19. Baert F, Moortgat L, van Assche G, et al. Mucosal healing predicts sustained clinical remission in patients with early-stage Crohn's disease. Gastroenterology 2010;138:463-8.
20. Colombel JF, Reinisch W, Mantzanis GJ, et al. Randomized clinical trial. Deep remission in biologic and immunomodulator naïve patients with Crohn's disease. A SONIC post hoc analysis. Aliment Pharmacol Ther 2015;41:734-46.
21. Nuti F, Civitelli F, Bioise S, et al. Prospective evaluation of the achievement of mucosal healing with anti-TNF-a therapy in a paediatric Crohn's disease cohort. J Crohns Colitis 2016;10:5-12.
22. Colombel JF, Rutgeerts PJ, Sandborn WJ, et al. Adalimumab induces deep remission in patients with Crohn's disease. Clin Gastroenterol Hepatol 2014; 12:414-22.