Background/Purpose: VISUAL clinical trials demonstrated efficacy and safety of adalimumab (ADA) in patients with active and inactive non-infectious, intermediate, posterior, or panuveitis (NIIPPU).^1-3 The purpose of this study (HOPE) was to evaluate disease characteristics and assess real-world effectiveness of ADA, including effects on treatment response (quiescence) and health resource utilization in patients with active NIIPPU.

Methods: HOPE was a post-marketing, prospective, observational study conducted in 15 countries. Included in the study were patients ≥18 years old with active NIIPPU (active, inflammatory, chorioretinal, and/or inflammatory retinal vascular lesion; or anterior chamber [AC] cells grade ≥2+; or vitreous haze [VH] grade ≥2+) despite high-dose corticosteroid therapy. Patient visits included baseline (V0) and follow-up at month 3 (V1), 6 (V2), 9 (V3), and 12 (V4). Patients received ADA per local prescription guidelines and signed informed consent. Excluded were patients with prior ADA treatment, participating in other clinical studies, or unwilling or unable to complete patient-reported questionnaires. Primary endpoint was proportion of patients in quiescence (no new active chorioretinal inflammatory lesions and AC cells and VH grade ≤0.5+ in both eyes) at any of the follow-up visits. Secondary endpoints were proportion of patients in quiescence at each visit; proportion of patients who maintained response (quiescence achieved at prior visit and no flare at current visit); and proportion of patients with flares (new active inflammatory lesions, AC cells grade ≥2+, or VH grade ≥2+ in ≥1 eye) at any visit. Visual function was assessed with National Eye Institute 25-Item Visual Function Questionnaire (VFQ-25). Serious adverse events (SAEs) were recorded at all visits.

Results: Patients in the full analysis set were assessed at V0 (n=149), V1 (n=147), V2 (n=143), V3 (n=133), and V4 (n=127). Of 149 patients, 62% were female, 43% had panuveitis, and 50% had idiopathic etiology; mean age was 42.3 years (Table). Quiescence was achieved by 92% of patients, and response was maintained in 83% of patients at any of the follow-up visits (Figure 1). Most patients achieved quiescence and maintained response at each visit (Figure 2). Flares occurred in 32% of patients at any of the follow-up visits. Proportion of patients with medical visits for uveitis during the preceding 6 months or since last visit decreased from 89% (132/149) at V0 to 39% (55/142) at V2 and 21% (27/126) at V4. Median change in overall VFQ-25 score from V0 to V2 and V4 was 3.3 (interquartile range [IQR], 0.4–13.4) and 5.1 (IQR, 0.4–15.7), respectively. SAEs were reported for 14 patients (9%).

Conclusion: In patients with active NIIPPU treated in routine clinical practice, ADA showed effectiveness in improving ocular inflammation, achieving quiescence, improving quality of life, and decreasing healthcare resource utilization. No new safety signals were identified.

References:

1. Jaffe GJ, et al. N Engl J Med. 2016;375:932-43.
2. Nguyen QD, et al. Lancet. 2016;388:1183-92.
3. Suhler EB, et al. Ophthalmology. 2018;125:1075-87.

Acknowledgment: Medical writing support was provided by N. Zhukovskaya of ICON (North Wales, PA) and was funded by AbbVie.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/impact-of-adalimumab-humira-therapy-on-ocular-inflammation-selected-health-care-resource-utilization-and-patient-reported-outcomes-in-patients-with-active-non-infectious-intermediate-posterior-o/