Background: Adalimumab remains the only biologic approved by the EMA and FDA for the treatment of non-infectious uveitis [1-6]. The reports on efficacy of other anti-TNF drugs such as Certolizumab Pegol (CZP) are scarce.
Objectives: to determine the efficacy and safety of CZP in refractory uveitis secondary to Immune-mediated Inflammatory Diseases (IMIDs).
Methods: national multicenter study of 80 patients with uveitis due to IMID refractory to glucocorticoids and conventional immunosuppressants treated with CZP. Efficacy was assessed with the following ocular parameters: best corrected visual acuity (BCVA), anterior chamber cells, vitritis, macular thickness and presence of retinal vasculitis. The efficacy of CZP was compared between the baseline visit, 1 st week, 1 st and 6 th month, and 1 st year. Statistical analysis was performed with IBM SPSS Statistics v.23.
Results: we studied 80 patients/111 affected eyes (33 men/47 women) with a mean age of 41.6±11.7 years. The IMIDs included were: spondyloarthritis (n=43), Behçet’s disease (10), psoriatic arthritis (8), Crohn’s disease (4), sarcoidosis (2), JIA (1), reactive arthritis (1), rheumatoid arthritis (1), relapsing polychondritis (1), TINU (1), pars planitis (1), Birdshot (1) and idiopathic uveitis (6). Anterior was the most frequent uveitis pattern (n=61).
In 20 patients, besides the presence of refractory uveitis, desire of pregnancy was the reason for CZP initiation.
Prior to CZP, patients had received: methotrexate (n=38), sulfasalazine (28), azathioprine (14), cyclosporine (10), leflunomide (3), mycophenolate mofetil (4), and cyclophosphamide (1). Previous biologic therapy was administered in 52 patients (63%), with a median [IQR] of 2 [1-3] drugs per patient. The most used biologic was adalimumab (n=48), followed by infliximab (32), golimumab (15), tocilizumab (5), etanercept (7), rituximab (1), anakinra (1) and secukinumab (1). CZP was administered as monotherapy in 39 patients.
After 24 [12-36] months of follow-up, all parameters analyzed showed a rapid and maintained improvement (
main ocular parameters analyzed in 80 patients with uveitis due to IMID and treated with CZP.
Baseline | 1st week | 1st month | 3rd month | 6th month | 1st year | |
---|---|---|---|---|---|---|
BCVA (mean±SD) | 0.68±0.27 | 0.73±0.26* | 0.79±0.26* | 0.82±0.25* | 0.85±0.24* | 0.86±0.23* |
Tyndall improvement , n (%) Patients with Tyndall + at baseline (n=57 ) | - | 23 (40.3) | 45 (78.9) | 47 (82.4) | 57 (100) | 57 (100) |
Vitritis improvement , n (%) Patients with Vitritis at baseline (n=14 ) | - | 5 (35.7) | 8 (57.1) | 13 (92.8) | 14 (100) | 14 (100) |
OCT (µm) (mean±SD) | 297.5±48.1 | 297.1±45.5 | 286.5±39.8* | 277.6±43.3* | 271.5±38.6* | 269.0±38.8* |
Choroiditis, affected eyes , n (%) | 3 (2.4) | 3 (2.4) | 2 (1.6) | 2 (1.6) | 1 (0.8) | 1 (0.8) |
Retinal vasculitis, affected eyes , n (%) | 3 (2.4) | 2 (1.6) | 1 (0.8) | 0 (0) | 0 (0) | 0 (0) |
*p<0.01
Conclusion: CZP seems to be effective and safe in the control of uveitis associated to different IMIDs.
REFERENCES:
[1]Jaffe GJ, et al. N Engl J Med 2016;375:932-43. doi: 10.1056/NEJMoa1509852.
[2]Nguyen QD, et al. Lancet 2016;388:1183-92. doi: 10.1016/S0140-6736(16)31339-3.
[3]Martín-Varillas JL, et al. Ophthalmology 2018; 125:1444-1451 doi: 10.1016/j.ophtha.2018.02.020
[4]Martín-Varillas JL, et al. J Rheumatol. 2021;48:741-750. doi: 10.3899/jrheum.200300
[5]Atienza-Mateo B. Arthritis Rheumatol. 2019;71:2081-2089. doi: 10.1002/art.41026.
[6]Vegas-Revenga N et al Am J Ophthalmol. 2019;200:85-94. doi: 10.1016/j.ajo.2018.12.019
Disclosure of Interests: None declared