Long-term efficacy and tolerability of TNFα inhibitors in the treatment of non-infectious ocular inflammation: an 8-year prospective surveillance study

Abstract

Background/aim: To report the efficacy and tolerability of antitumour necrosis factor-alpha therapy (TNF inhibitors [TNFi]) in the management of non-infectious ocular inflammation, including uveitis and scleritis, in adult patients over an 8-year period.

Materials and methods: This is a prospective cohort study of infliximab and adalimumab in the treatment of non-infectious ocular inflammatory disease. 43 of 85 adult patients on TNFi (34 infliximab, 9 adalimumab) for ≥1 year with non-infectious uveitis or scleritis were followed from 2006 to 2014. Clinical assessments, medication, adverse events and history of steroid rescues were collected at 6 monthly intervals. General quality of life (Short Form Health Survey (SF-36)) and visual quality of life (Vision-related quality of life Core Measure (VCM1)) were assessed annually. Outcome measures included rate of sustained remission, rate of relapse, systemic corticosteroid reduction, adverse events, and VCM1 and SF-36 scores.

Results: The median time on infliximab was 3.2 years (IQR 4.3) and on adalimumab was 2.4 years (IQR 1.8). Sustained remission was induced in 39 patients (91%) (0.5 per patient year) after a median of 1.2 years on a TNFi. 22 (51%) experienced one relapse, and 5 (12%) had two relapses. 23 (54%) had at least one adverse event; serious adverse events necessitating hospitalisation or cessation of medication occurred in four (9%) patients. 10 patients (23%) switched from the initiation of TNFi, at 1.7 years after starting, to another TNFi or another class of biologic therapy.

Conclusion: TNFi treatment is associated with long-term drug-induced remission of ocular inflammation, visual stability and corticosteroid reduction. Adverse events were common and no new safety signals occurred. Relapse of inflammation occurs in half of the treated population.

Keywords: drugs; immunology; inflammation.

Figure 1

Study Diagram.

Figure 2

Sustained remission and relapse during follow up. Kaplan Meier estimator curve of the probability ofpatients (y-axis) experiencing (A) sustained remission and (B) relapse following remission on eitheradalimumab or infliximab. The x-axis shows the time to either outcome.

Figure 3

General quality of life and visual quality of life Mean change in General QoL (SF36)* and Visual QoL* (VCM1) scores from the baseline visit to each year of treatment on either adalimumab or infliximab. (A) SF36 mental component, (B) SF36 physical component and (C) VCM1 Visual QoL. (N indicates the number of participants for each year of treatment. Error bars represent the standard error. For SF36, a positive change indicates improvement of QoL. For VCM, a negative change indicates improvement of visual QoL. *The SF36 summarises 8 dimensions of general health into a Physical Component Score (PCS) and a Mental Component score (MCS), ranging from 0 to 100 (best score). The VCM1 is a 10 point visual QoL which captures patient–reported measures of visual health on emotional, physical, social and psychological aspects of visual quality of life.