Efficacy of Tacrolimus in Uveitis, and the Usefulness of Serum Tacrolimus Levels in Predicting Disease Control. Results from a Single Large Center

Figures & data

Table 1. Patient demographics and disease characteristics.

Age		49.06 ± 11.59 years
Gender
	Female	47 (66%)
	Male	24 (34%)
Ethnicity
	Caucasian	59 (83%)
	Asian	8 (11%)
	Black African/Caribbean	3 (4%)
	Chinese	1 (1%)
Laterality
	Bilateral	60 (85%)
	Unilateral	11 (16%)
Anatomical location
	Posterior uveitis	38 (54%)
	Intermediate uveitis	13 (18%)
	Panuveitis	12 (17%)
	Scleritis	7 (10%)
	Anterior uveitis	1 (1%)
Etiology
	Birdshot	30 (42%)
	Idiopathic	20 (28%)
	Behcet’s	4 (6%)
	Multifocal choroiditis	3 (4%)
	Sarcoidosis	3 (4%)
	VKH	3 (4%)
	Punctate inner choroidopathy	2 (3%)
	Tubercular/serpiginous	2 (3%)
	Granulomatosis with polyangiitis	1 (1%)
	Presumed ocular histoplasmosis syndrome	1 (1%)
	Surgically induced	1 (1%)
	Sympathetic ophthalmia	1 (1%)
Total		71

Table 2. Disease control at 1 year follow-up.

					Disease uncontrolled		Disease controlled
Number					22		49
Tacrolimus therapy		Stopped before 1 yr			16 (73%)		4 (8%)
		Continuing at 1 yr			6 (27%)		45 (92%)
					p < .0001
Average trough serum tacrolimus concentration		< 5 ng/mL			15 (79%)		17 (36%)
		≥ 5 ng/mL			4 (21%)		30 (64%)
					p = .002
Local steroid therapy			Not given		19 (86%)		48 (98%)
			Given		3 (14%)		1 (2%)
					p = .085
Final oral steroid therapy dose	<7.5 mg				13 (59%)		20 (41%)
	≥7.5 mg				9 (41%)		20 (41%)
					p = .15
Concurrent immunosuppressive agents during treatment period				Decreased by 1	4 (18%)		7 (14%)
				Unchanged	10 (45%)		39 (80%)
				Increased by 1	8 (36%)		3 (3%)
					p = .003

Table 3. Side effects from oral tacrolimus at 1-year follow-up.

Mood and sleep disturbance	6 (9%)
Pain	4 (6%)
Tremors	2 (3%)
Paraesthesia	2 (3%)
Gastrointestinal symptoms	2 (3%)
Hair loss	1 (1%)
Renal impairment and haematuria	1 (1%)
Total discontinuation due to side effects	12 (17%)

Table 4. Concurrent therapy at the start of tacrolimus therapy and 1-year follow-up.

	Start of tacrolimus		1-year follow-up
	N (%)	Median dose (mg, IQR)	N (%)	Median dose (mg, IQR)
Prednisolone*	63 (89%)	11.25 (10.00–23.75)	56 (79%)	8.75 (5.00–10.00)
Prednisolone ≥ 7.5 mg*	61 (86%)		38 (54%)
Mycophenolate	39 (55%)	2000	35 (49%)	2000
Azathioprine	4 (6%)	100	3 (4%)	100
Methotrexate	3 (4%)	17.5	2 (3%)	17.5
Cyclosporine	0 (0%)	-	1 (1%)	200
Anti-TNF	1 (1%)	-	4 (6%)	-

*p < 0.0001; TNF, Tumor necrosis factor; IQR, interquartile range

Table 5. Multivariate model for disease control.

Factor	Odds ratio	95% CI	P value
Average trough STC	1.67	1.21–2.29	0.002
Change in concurrent immunosuppressive therapy	0.23	0.07–0.84	0.026
		R^2 = 0.388