Intest Res.  2018 Jan;16(1):83-89. 10.5217/ir.2018.16.1.83.

Efficacy and safety of the adalimumab biosimilar Exemptia as induction therapy in moderate-to-severe ulcerative colitis

• Midha V
• Mahajan R
• Mehta V
• Narang V
• Singh A
• Kaur K
• Sood A

• KMID: 2402651
• DOI: http://doi.org/10.5217/ir.2018.16.1.83

Abstract

BACKGROUND/AIMS
Data on the efficacy and safety of the adalimumab biosimilar Exemptia are limited.
METHODS
Patients with moderate-to-severe active steroid-refractory ulcerative colitis (UC) treated at Dayanand Medical College and Hospital, India were offered cyclosporine A, biologicals or biosimilars, or surgery. A retrospective analysis was conducted on patients who were treated with the adalimumab biosimilar, Exemptia. These patients were administered an induction dosing schedule of 160 mg Exemptia at week 0, 80 mg at week 2, and then 40 mg every other week from week 4 to 8. The clinical response and remission were assessed at week 8 using Mayo score.
RESULTS
A total of 29 patients (62.1% male; mean age, 34.9 ± 9.7 years) with moderate-to-severe steroid-refractory active UC (mean disease duration, 6.3±5.1 years; pancolitis in 9 patients [31.1%]; left-sided colitis in 20 patients [68.9%]) were treated with the Exemptia induction dosing schedule. The mean Mayo score at presentation was 8.2±1.4. At week 8, clinical response was observed in 7 patients (24.1%), whereas clinical remission was observed only in 1 patient (3.5%). Among the non-responders (n=21), 4 patients required colectomy, 1 died, 1 was lost to follow-up, 10 were offered fecal microbiota transplant, 3 were administered infliximab, and 2 patients were administered cyclosporine and tacrolimus, respectively. Four patients (13.8%) developed extrapulmonary tuberculosis.
CONCLUSIONS
The adalimumab biosimilar Exemptia has limited efficacy for the attainment of clinical response and remission in moderate-to-severe steroid-refractory UC, with a significant risk of acquisition or reactivation of tuberculosis in developing countries such as India.

Keyword

Adalimumab biosimilar; Exemptia; Steroid-refractory ulcerative colitis

MeSH Terms

Adalimumab*
Appointments and Schedules
Biosimilar Pharmaceuticals
Colectomy
Colitis
Colitis, Ulcerative*
Cyclosporine
Developing Countries
Humans
India
Infliximab
Lost to Follow-Up
Male
Microbiota
Retrospective Studies
Tacrolimus
Tuberculosis
Ulcer*
Adalimumab
Biosimilar Pharmaceuticals
Cyclosporine
Infliximab
Tacrolimus

Figure

• 

  Fig. 1 Efficacy of Exemptia in treating moderate-to-severe active UC (total=29). Among the 29 patients with moderate-to-severe UC who were treated with Exemptia, clinical response at week 8 was observed in 7 patients (24.1%), but only 1 patient (3.5%) achieved clinical remission.

• 

  Fig. 2 Response/remission in patients with moderate-to-severe active UC treated with Exemptia. Patients with moderate-to-severe active UC who showed clinical response at week 8 (n=8, 27.6%) were maintained on azathioprine after the initial induction therapy with Exemptia. Only 1 of 7 patients achieved clinical remission at week 8. Of the 21 patients who did not respond, 4 required colectomies, 1 died, and 1 was lost to follow-up. Salvage measures in the other patients included fecal microbiota transplantation (n=10), infliximab (n=3), cyclosporine (n=1), and tacrolimus (n=1) administration.

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