Efficacy And Safety Of Adalimumab Biosimilar (Exemptia) In Moderate-To-Severe Steroid-Refractory Ulcerative Colitis Patients: Real-Life Outcomes In Resource-Constrained Setting At 24-Weeks Follow-Up

Figures & data

Table 1 Mayo Scoring System

Variable	0 Points	1 Points	2 Points	3 Points
Bowel Movement (BM) Frequency	Normal	1–2 BM >normal	3–4 BM >normal	5 or more BM> normal
Rectal Bleeding	None	Streaks on stool < 50% BMs	Obvious fresh blood with most BM’s	BM’s with fresh blood
Mayo Endoscopy Sub-score (MESS)	Normal	Mild erythema, decreased vascularity, mild friability	Marked erythema, loss of vascular pattern, friability, erosions	Spontaneous bleeding, ulceration
Physician Global Assessment (PGA)	Normal	Mild	Moderate	Severe

Table 2 Baseline And Demographic Patient Characteristics

Characteristic	Value
Number of patients	25
Age	35.64 ± 12.58
Sex Male: Female	11:14
Male	11 (44%)
Female	14 (66%)
Disease extent
Proctitis (E 1)	2 (8%)
Distal colitis (E2)	11 (44%)
Pancolitis (E3)	12 (48%)
Disease duration
Hemoglobin (g/dL)	10.1 ± 1.99
Albumin (g/dL)	3.21 ± 0.39
ESR	31 ± 12.0
Weight	55.84± 5.92
Mayo score, mean	10.16 ± 0.90
Prior exposure
5-Aminosalicylates	25 (100%)
Azathioprine	24 (96%)
Corticosteroids	25 (100%)
Infliximab	2 (8%)

Figure 1 Study design in ulcerative colitis patients on ADA biosimilar and reasons for discontinuation.

Figure 2 Clinical remission/response at 12-weeks follow-up.

Figure 3 Clinical remission/response at 24-weeks follow-up.

Figure 4 Total Mayo Score (TMS) at Baseline, 12weeks and 24 weeks (N=25 at 12 weeks and N=23 at 24 weeks).

Figure 5 Mayo endoscopic sub-score (MESS) at Baseline, 12weeks and 24 weeks (N=25 at 12 weeks and N=23 at 24 weeks).

Table 3 Total Mayo Score (TMS) And Mayo Endoscopic Sub-Score (MESS) At Baseline, 12 Weeks And 24 Weeks (N= 25 At 12 Weeks And N=23 At 24 weeks)

	Total Mayo Score Significant (P < 0.05)	Mayo Endoscopic Sub-Score Significant (P < 0.05)
Baseline vs 12 Weeks	Yes	Yes
Baseline vs 24 Weeks	Yes	Yes
12 Weeks vs 24 Weeks	No	No

Table 4 Total Mayo Score (TMS) And Mayo Endoscopic Sub-Score (MESS) Of 14 Patients Whose Dose Has Been Accelerated At 12 Weeks From Once In 4 Weeks To Once In 2 Weeks

	Baseline	12 Weeks	24 Weeks
Total Mayo Score (Mean)	10.29 ± 0.61	7.86 ± 1.29	7.46 ± 2.44
Mayo Endoscopic Sub-Score (Mean)	2.93 ± 0.27	2.14 ± 0.36	2.08 ± 0.64
Clinical Response		5	6
Non-Responders		9	7
Adverse Events (TB)		0	1

Table 5 Various Reported Real-Time Studies On Adalimumab In UC

S.No	Study	Country	N	Clinical Remission (12 Weeks)	Clinical Response (12 Weeks)	Clinical Remission (24 Weeks)	Clinical Response (24 Weeks)	Colectomy
1	Current study	India	25	16%	48%	16%	44%	0
2	Taxonera et al, 2011^Citation15	Spain	30	26.7%	60%	–	–	20%
3	Balint et al, 2016^Citation28	Hungary	73	26%	49.3%	–	–	5.4%
4	Afif et al, 2009^Citation11	USA	20	5% (8 weeks)	25% (8 weeks)	20%	50%	0
5	Armuzzi et al, 2013^Citation16	Italy	88	23.4%		36.4%		25%
6	Szepes et al, 2014^Citation27	Hungary	56	23.2 %	52%	54.5% (30 weeks)	27.5% (30 weeks)	–

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