Background: Spain has the second highest number of Chagas disease-infected patients among non-endemic countries. However, there is limited knowledge about pharmacist involvement in managing patients with Chagas disease. Method: A retrospective observational study was performed in two periods (before and after intervention) to describe the characteristics of patients with Chagas disease. Pharmacist intervention, based on two pharmacist-visit programs and development of information for patients, was applied to patients under pharmacological treatment in a non-endemic country. Depending on the initial results in 2010e2011, specific pharmacist attention program for patients with Chagas disease was implemented in 2012. The results of 2010e2011 (before intervention) and 2013 (after intervention) were compared. Results: A high number of adverse drug reactions were reported in both periods, 50.0% (2010e2011) vs. 90.9% (2013). With regard to treatment completion, in 2010e2011, 60% achieved the treatment completion criteria (>95% days of treatment) vs. 68.2% in 2013 (p Z 0.580). There was, however, a significant increase in the detection of ADRs in the second period (50.0% vs. 90.9%; p Z 0.003) and an increase in the severity (75% [6/8] of uncompleted treatments were due to ADRs vs. 100% [7/7] in the first and second period, respectively).

BackgroundAdalimumab 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.Objectivesto determine the efficacy and safety of CZP in refractory uveitis secondary to Immune-mediated Inflammatory Diseases (IMIDs).Methodsnational 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, 1st week, 1st and 6th month, and 1st year. Statistical analysis was performed with IBM SPSS Statistics v.23.Resultswe 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 (Table 1). A decrease in the mean number of uveitis flares was observed before and after CZP, (2.6±2.3 vs. 0.6±0.4, p<0.001). CZP was discontinued in 16 patients due to: ocular remission (n=3), insufficient ocular response (4) and incomplete response of extraocular manifestations (9). No serious adverse effects were found.Table 1.main ocular parameters analyzed in 80 patients with uveitis due to IMID and treated with CZP.Baseline1st week1st month3rd month6th month1st yearBCVA (mean±SD)0.68±0.270.73±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±48.1297.1±45.5286.5±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<0.01ConclusionCZP 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.2018.12.019Disclosure of InterestsNone declared

BackgroundCystoid Macular Edema (CME) is the leading cause of blindness in non-infectious uveitis. Behçet’s disease (BD) is one of the diseases most frequently associated with CME [1-4].Objectivesto compare the efficacy and safety of Certolizumab (CZP) and Adalimumab (ADA) in CME due to BD refractory to conventional therapy.Methodsmulticenter study of patients with CME secondary to BD refractory to glucocorticoids (GC) and at least 1 conventional immunosuppressant. All patients had CME (OCT>300µ) at baseline. Efficacy was assessed with the following ocular parameters: macular thickness (µm), visual acuity (BCVA) and GC-sparing effect. The efficacy of CZP vs. ADA was compared between the baseline visit, 1st and 6th month, and 1st and 2nd year. Statistical analysis was performed with IBM SPSS Statistics v.23.ResultsWe studied 21 patients/38 affected eyes were studied. 10 patients were treated with CZP (200 mg c/2 weeks) and 11 with ADA (loading dose of 80 mg and subsequently 40 mg c/2 weeks).No statistically significant baseline differences were observed in both groups (CZP vs. ADA) in sex (♂/♀; 3/7 vs 5/6; p=0.65) and mean age (36.1±8.0 vs 42.2±8.6; p=0.10). However, CZP group was more severe with a longer time between EB diagnosis and biologic initiation (91.6±71.4 vs 34.4±21.3 months, p=0.02), and a greater median [IQR] number of previous biologic drugs (2 [0.75-3] vs 0 [0-0]). In CZP group, 8 patients were previously treated with ADA.Combined therapy with conventional DMARDs was used with ADA in 81.8% vs. 18.2% of CZP patients.Regarding the efficacy outcomes analyzed, a rapid and maintained improvement in macular thickness, measured by OCT, was observed after 2 years of follow-up in both groups with no statistically significant differences between them (Table 1). Improvement in visual acuity and a GC-sparing effect was also observed (Table 1).Table 1.main ocular parameters compared in the CZP-treated group and in the ADA-treated group.CZP(n=10)ADA(n=11)PBaseline  OCT (µm, mean±SD)380.7±96.4416.9±171.10.56 BCVA (mean±SD)0.72±0.300.57±0.200.21 Prednisone (mg/dl, mean±SD)13.1±11.434.1±18.90.071st month  OCT (µm, mean±SD)333.7±60.4302±44.20.19 BCVA (mean±SD)0.80±0.270.72±0.180.45 Prednisone (mg/dl, mean±SD)8.1±5.5112.1±6.40.316th month  OCT (µm, mean±SD)284.4±45.5272.8±38.90.53 BCVA (mean±SD)0.82±0.230.86±0.160.65 Prednisone (mg/dl, mean±SD)6.8±6.66.1±2.80.921st year  OCT (µm, mean±SD)269.0±46.8260.9±39.50.67 BCVA (mean±SD)0.82±0.230.89±0.170.48 Prednisone (mg/dl, mean±SD)6.2±3.05.8±2.10.872nd year  OCT (µm, mean±SD)289.4±49.3248.0±42.00.16 BCVA (mean±SD)0.87±0.200.87±0.171.0 Prednisone (mg/dl, mean±SD)3.7±1.23.1±2.30.90No serious adverse events were observed in either group.ConclusionOur study suggests that both CZP and ADA are effective in the treatment of CME due to BD refractory to conventional treatment. CZP was equally effective despite most patients were refractory to ADA.References[1]Schaap-Fogler M, et al. Graefes Arch Clin Exp Ophthalmol. 2014 Apr;252(4):633-40. doi: 10.1007/s00417-013-2552-8.[2]Martín-Varillas JL, et al. Ophthalmology 2018; 125:1444-1451 doi: 10.1016/j.ophtha.2018.02.020[3]Martín-Varillas JL, et al. J Rheumatol. 2021;48:741-750. doi: 10.3899/jrheum.200300[4]Vegas-Revenga N et al Am J Ophthalmol. 2019;200:85-94. doi: 10.1016/j.ajo.2018.12.019Disclosure of InterestsNone declared

Backgroundthe main cause of blindness in non-infectious uveitis is cystoid macular edema (CME). Behçet’s disease (BD) is one of the most common diseases associated with CME [1-3].Objectivesto compare efficacy and safety of Adalimumab (ADA), Infliximab (IFX) and Certolizumab (CZP) in refractory CME due to BD.Methodsmulticenter study of patients with CME secondary to BD refractory to glucocorticoids (GC) and at least 1 conventional immunosuppressant. All patients had CME (OCT>300µ) at baseline. From baseline up to 2 years, efficacy of ADA, IFX and CZP was assessed with the following ocular parameters: macular thickness (µm), visual acuity (BCVA), anterior chamber (AC) cells, vitritis and GC-sparing effect. Statistical analysis was performed with IBM SPSS Statistics v.23.Resultsa total of 50 patients (78 eyes) were considered. Twenty-five patients were treated with ADA, 15 patients with IFX and 10 patients were treated with CZP. No significant differences in demographic parameters were observed in the three groups. However, patients in the CZP group had a significantly longer time from diagnosis to drug initiation (75 [36-120] vs 30 [12-82] vs 15 [8-60] months; p=0.04) and received a greater median number of biological treatments (2 [0.75-3] vs 0 [0-0] vs 0 [0-0]) than the ADA and IFX groups. In CZP group, ADA and IFX were used previously in 7 patients. Combined therapy was used with ADA in 64%, with IFX in 66.7% and with CZP in 70% of CZP patients (p=0.94) (TABLE 1).Regarding efficacy outcomes, a rapid and maintained improvement in macular thickness was observed after 2 years of follow-up in three groups with no statistically significant differences between them (FIGURE 1). Improvement in BCVA, AC cells, vitritis and a GC-sparing effect was also noted. No serious adverse events were observed in IFX and CZP group. One case of pyelonephritis was reported in the ADA group.ConclusionADA, IFX and CZP seem to be effective and safe in refractory CME due to BD. CZP appears effective even in patients with inadequate response to ADA and/or IFX.References[1]Martín-Varillas JL, et al. J Rheumatol. 2021;48:741-750.[2]Martín-Varillas JL, et al. Ophthalmology 2018; 125:1444-1451.[3]Martín-Varillas JL, et al. RMD Open 2022;8:e002693.Table 1.Main characteristics of CME-BD patients receiving adalimumab (ADA), infliximab (IFX) or Certolizumab (CZP).ADAgroup(n=25)IFXgroup(n=15)CZPgroup(n=10)PAge, mean (SD) years41 (11)38 (9)36 (8)0.34Sex, men/women, n/n12/137/83/70.61HLA-B51 positive, n(%)19 (76)10 (67)4 (40)0.13Duration of uveitis before treatment, median30 [12-82]15 [8-60]75 [36-120]0.04Unilateral, n(%)10 (40)9 (60)3 (30)0.28Pattern of uveitis, n(%)Anterior0 (0)0 (0)2 (20)–Intermediate0 (0)0 (0)1 (10)0.13Posterior5 (20)5 (33.3)3 (30)0.62Panuveitis20 (80)10 (66.7)4 (40)0.07Ocular outcomes at the time of anti-TNF beginningAC cells (Tyndall), median [IQR]2 [1-3]1 [0-1]1 [0-2]0.15Vitritis, median [IQR]3 [1-3]1 [0-2]1 [0-2]0.03BCVA, mean (SD)0.41±0.240.33±0.220.48±0.180.17Macular thickness, mean (SD)431.9±117.6483.4±126.1380.7±96.50.08Previous conventional treatment, n (%)IV pulses of MTP13 (52)9 (60)5 (50)0.85Cyclosporine A22 (88)11 (73.3)6 (60)0.17Azathioprine14 (56)8 (53.3)4 (40)0.69Methotrexate13 (52)8 (53.3)2 (20)0.18CFM1 (4)2 (13.3)0 (0)0.33Previous biological treatment (BT), n (%)0 (0)0 (0)8 (80)-Number of previous BT per patient, median [IQR]002 [1-3]-Combined treatment, n (%)16 (64)10 (66.7)7 (70)0.94Cyclosporine A10 (40)5 (33.3)1 (10)0.23Azathioprine4 (16)3 (20)2 (20)0.34Methotrexate2 (8)2 (13.3)4 (40)0.86Prednisone dose (baseline)45 [30-60]30 [20-60]8 [6-25]0.04Follow-up, median [IQR],24 [18-45]24 [3-36]30 [24-60]0.12Remission, n (%)19 (76)9 (60)7 (70)0.58per 100 patient-year28.83019.40.20Drug withdrawal, n (%)8 (32)8 (53.4)2 (20)-per 100 patient-year12.126.75.6Side-effects/toxicity, n (%)1 (4)0 (0)0 (0)per 100 patient-year300Figure 1.Evolution of OCT and BCVA after adalimumab (ADA), infliximab (IFX) or Certolizumab (CZP) initiation.Acknowledgements:NIL.Disclosure of InterestsNone Declared.