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Aqueous penetration of topical tacrolimus.

ABSTRACT: Purpose:To evaluate the penetration of topical tacrolimus 0.05% into the aqueous humor. Observations:A total of four patients scheduled for routine cataract surgery were included prospectively. We excluded patients with corneal pathology or ocular surface diseases. Topical tacrolimus 0.05% was compounded at our facility. It was dosed every 1 min for 5 min an hour before the aqueous was sampled. Aqueous samples were collected at the time of cataract surgery and were subjected to detection of presence and level of tacrolimus. There were 2 male and 2 female patients. The age range was 58-73 years with a mean age of 66 years. Tacrolimus was detected in the aqueous humor in all patients. The concentration of tacrolimus in the aqueous ranged from 2.6 to 5.6 ng/ml (mean 4.15 ± 1.18 ng/ml). In all patients, the aqueous tacrolimus concentration was greater than the minimal therapeutic level. The study was registered at clinicaltrials.gov (registration number is NCT02794610). Conclusions and Importance:Tacrolimus was detected in the aqueous humor following topical application. Topical tacrolimus may be a promising steroid-sparing modality for the treatment of anterior uveitis.

SUBMITTER: Shoughy SS

PROVIDER: S-EPMC6997506 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Aqueous penetration of topical tacrolimus.

Shoughy Samir S SS Aljassar Faisal M FM Tabbara Khalid F KF

American journal of ophthalmology case reports 20200117

<h4>Purpose</h4>To evaluate the penetration of topical tacrolimus 0.05% into the aqueous humor.<h4>Observations</h4>A total of four patients scheduled for routine cataract surgery were included prospectively. We excluded patients with corneal pathology or ocular surface diseases. Topical tacrolimus 0.05% was compounded at our facility. It was dosed every 1 min for 5 min an hour before the aqueous was sampled. Aqueous samples were collected at the time of cataract surgery and were subjected to de ...[more]

PMID: 32025589

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Project description:OBJECTIVE: To determine the efficacy and tolerability of topical pimecrolimus and tacrolimus compared with other treatments for atopic dermatitis. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Electronic searches of the Cochrane Library, Medline, and Embase. STUDY SELECTION: Randomised controlled trials of topical pimecrolimus or tacrolimus reporting efficacy outcomes or tolerability. DATA EXTRACTION: EFFICACY: investigators' global assessment of response; patients' global assessment of response; proportions of patients with flares of atopic dermatitis; and improvements in quality of life. Tolerability: overall rates of withdrawal; withdrawal due to adverse events; and proportions of patients with burning of the skin and skin infections. DATA SYNTHESIS: 4186 of 6897 participants in 25 randomised controlled trials received pimecrolimus or tacrolimus. Both drugs were significantly more effective than a vehicle control. Tacrolimus 0.1% was as effective as potent topical corticosteroids at three weeks and more effective than combined treatment with hydrocortisone butyrate 0.1% (potent used on trunk) plus hydrocortisone acetate 1% (weak used on face) at 12 weeks (number needed to treat (NNT) = 6). Tacrolimus 0.1% was also more effective than hydrocortisone acetate 1% (NNT = 4). In comparison, tacrolimus 0.03% was more effective than hydrocortisone acetate 1% (NNT = 5) but less effective than hydrocortisone butyrate 0.1% (NNT = -8). Direct comparisons of tacrolimus 0.03% and tacrolimus 0.1% consistently favoured the higher strength formulation, but efficacy differed significantly between the two strengths only after 12 weeks' treatment (rate ratio 0.80, 95% confidence interval 0.65 to 0.99). Pimecrolimus was far less effective than betamethasone valerate 0.1% (NNT = -3 at three weeks). Pimecrolimus and tacrolimus caused significantly more skin burning than topical corticosteroids. Rates of skin infections in any of the comparisons did not differ. CONCLUSIONS: Both topical pimecrolimus and topical tacrolimus are more effective than placebo treatments for atopic dermatitis, but in the absence of studies that show long term safety gains, any advantage over topical corticosteroids is unclear. Topical tacrolimus is similar to potent topical corticosteroids and may have a place for long term use in patients with resistant atopic dermatitis on sites where side effects from topical corticosteroids might develop quickly. In the absence of key comparisons with mild corticosteroids, the clinical need for topical pimecrolimus is unclear. The usefulness of either treatment in patients who have failed to respond adequately to topical corticosteroids is also unclear.

Project description:PurposeBreast cancer-related lymphedema (BCRL) is a chronic, progressive side effect of breast cancer treatment, occurring in one-third of patients treated with axillary lymph node dissection and nodal radiotherapy. Cluster of differentiation 4-positive (CD4+) cells plays a key role in BCRL by facilitating inflammation and inhibiting lymphangiogenesis. Tacrolimus is an anti-inflammatory and immunosuppressive macrolide that targets CD4+ cells. Treatment of lymphedema with topical tacrolimus has revealed promising results in preclinical trials. This clinical trial was aimed at evaluating the feasibility, safety, and effect of tacrolimus in women with stage I or II BCRL, according to the International Society of Lymphology.MethodsWe conducted this open-label, single-arm, phase II pilot trial from September 2020 to April 2021. Eighteen women with BCRL stage I or II BCRL were treated with topical tacrolimus for 6 months and followed up at 3 and 6 months. The primary outcome was arm volume, and secondary outcomes were the lymphedema index (L-Dex), health-related quality of life (HRQoL), lymph flow and function, and safety and feasibility of the trial design.ResultsThe mean lymphedema arm volume and L-Dex reduced significantly by 130.44 ± 210.13 mL (p < 0.05; relative reduction: 3.6%) and 3.54 ± 4.98 (p < 0.05), respectively, and health-related quality of life scores was improved significantly (p < 0.05). According to the MD Anderson scale, in terms of lymph flow and function, three patients (16.7%) showed improvement, while none showed worsening. Lymph flow or function showed no change according to the Arm Dermal Backflow scale.ConclusionIn this trial, treatment with tacrolimus was safe and feasible in women with stage I or II BCRL. Tacrolimus alleviated BCRL in terms of improved arm volume, L-Dex, and HRQoL. Assessments of lymph flow and function were positive, although inconclusive. Larger randomized controlled trials are required to verify these findings.Trial registrationClinicalTrials.gov Identifier: NCT04541290.

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Aqueous penetration of topical tacrolimus.

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Aqueous penetration of topical tacrolimus.

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