Background TNF-alfa blockers are highly effective for signs and symptoms in patients with ankylosing spondylitis (AS). Many clinical studies and data from various national registries assign concerns about serious infections, especially tuberculosis (TB). Objectives Our aim was to look on the incidence rate (IR) of TB infection in AS patients during anti-TNF therapy in Slovakia. Methods AS patients on anti-TNF treatment were retrospectively analyzed in Slovak national database of patients with biological therapy. This analysis covered AS patients on infliximab, etanercept, adalimumab and golimumab since March 3rd 2003, when the first patient was initiated on TNF-alfa blocker until December 31st 2012. Duration of anti-TNF treatment was calculated on patient-years (PY). IR for development of TB on 100 PY was calculated. The occurence of TB reactivation was subsequently analysed after initiation of national guidelines for screening of latent TB. Results 314 patients with AS on anti-TNF therapy, 278 men (89%) and 36 women (11%), were analysed. The mean age of patients at the time of initiation of TNF-alfa blockers was 39.27 (19-72) years. The time on biological treatment since the first patient was initiated until December 31st 2012 was calculated on 915 PY. 75 patients (72 men, 3 women) on infliximab were together treated 248 PY, 87 patients (71 men, 16 women) on etanercept 339 PY, 122 patients (112 men, 10 women) on adalimumab 286 PY, and 30 patients (23 men, 7 women) were under the treatment with golimumab 41 PY. The occurrence of pulmonary TB in AS patients treated by TNF-alfa inhibitors was found only in one patient on infliximab, and it was before the initiation of screening of latent TB. There was no case of active TB during etanercept, adalimumab or golimumab therapy. One patient on infliximab developed atypical mycobacterial infection of skin with histological finding of aquarium granuloma. One patient on etanercept had to stop treatment due to his contact with person with active TB, but after prophylactic treatment with isoniaside (INH) he could continue on biologic agent without development of active TB. Calculated incidence of TB infection (typical and atypical) in Slovak AS patients on anti-TNF therapy was 0.21/100 PY. The IR for reactivation of latent TB was calculated on 0.1/100 PY. After applying the national guidelines for screening of latent TB before starting TNF-inhibitors there was no case of TB reactivation in Slovak AS patients. There were 7 patients with positive IGRA test before starting infliximab, 5 patients before etanercept, 11 patients before adalimumab and 3 patients before starting golimumab. All patients with positive IGRA test underwent prophylactic treatment with INH and no reactivation of latent TB was observed. Conclusions The risk of TB infection in AS patients on anti-TNF therapy in Slovakia is 0.21/100 patient-years, with the IR for reactivation of latent TB during the treatment 0.1/100 patient-years. After applying national guidelines for screening latent TB before starting...
BackgroundPsoriasis is one of the most common extra-articular manifestations in patients with ankylosing spondylitis (AS). TNF inhibitors (TNFi) are highly effective for signs and symptoms of AS and psoriasis. However, there is some evidence about exacerbation or new onset of cutaneous psoriasis during anti TNF therapy.ObjectivesTo examine the incidence rate of worsening or new onset of psoriasis in AS patients during anti-TNF therapyMethodsAS patients with TNFi were retrospectively analysed in database of patients with biological therapy in Slovakia. This analysis covered AS patients with infliximab, etanercept, adalimumab and golimumab since March 3rd 2003, when the first patient initiated TNFi until December 31st 2013. Duration of anti-TNF treatment was calculated on patient-years (PYs). Disease activity was evaluated by BASDAI, ESR, CRP and global patient assessment of disease activity. History of psoriasis in each patient was explored and worsening of psoriasis or the first episode cases during anti-TNF therapy were analysed. Incidence rate was calculated on 100 PYs, and differences among TNFi were assessed.Results385 patients with AS on TNFi were analyzed, of them 327 men (85%) and 58 women (15%). Mean age of patients at the time of initiation of TNF blockers was 39.0 (±10.7) years, median was 37 years (IQR 31-47). Total time on anti-TNF therapy was calculated on 1129 patient-years. 81 patients were exposed to infliximab for a total of 274 PYs, 102 patients were exposed to etanercept for 394 PYs, 155 patients were treated with adalimumab 390 PYs, and 47 patients were under the treatment with golimumab 72 PYs. Cutaneous psoriasis was present in 20 patients (5.2%) in history before starting TNFi – 8 patients on infliximab (9.9%), 8 patients on adalimumab (5.2%), 2 patients on etanercept (2.0%) and 2 patients on golimumab (2.0%). During anti-TNF therapy, exacerbation of cutaneous psoriasis was found only in 2 patients, but first episode cases were described in 6 ones. In every case, dermatologist verified the diagnosis of cutaneous psoriasis, and 50% of all cases had palmo-plantar pustular form of psoriasis, reflecting possible paradoxical reaction of the TNFi. Incidence of paradoxical psoriatic reaction was calculated on 0.71/100 PYs. Relatively more paradoxical psoriatic reactions during anti-TNF therapy were observed in patients with infliximab (1.09/100 PYs) and golimumab (1.41/100 PYs) than in patients with adalimumab and etanercept (both 0.51/100 PYs).ConclusionsIncidence of paradoxical psoriatic effects of anti-TNF therapy in AS patients is very low. Our findings demonstrate that palmo-plantar pustular psoriasis is the most common form of paradoxical skin lesions. They were less frequent in patients treated with etanercept than in patients treated with monoclonal antibodies infliximab and golimumab.Disclosure of InterestNone declared
BackgroundTNF-inhibitors (TNFi) have brought new perspectives for AS patients to control disease activity and improve quality of life. However, some concerns still exist about their safety, especially in long term use.ObjectivesTo evaluate persistence of AS patients on anti-TNF therapy, to identify the most common reasons of TNFi discontinuation, and to find out any difference in survival curves among these drugsMethodsAS patients with TNFi in Slovakia were retrospectively analysed since March 3rd 2003 until December 31st 2013. Duration of anti-TNF therapy was calculated on patient-years (PYs). Disease activity was evaluated by BASDAI, ESR, CRP and global patient assessment of disease activity. Adherence to therapy was evaluated using Kaplan-Meier analysis and results were expressed as cumulative survival. Logrank analysis was used to compare survival curves among TNFi. Hazard ratio (HR) for drug discontinuation was calculated for each individual TNFi. Cox proportional-hazard regression analysis was used for evaluation of risk factors of treatment discontinuation. Adverse events leading to drug discontinuation were closely monitored. Statistical analyses were performed using MedCalc Software, version 12.5, Ostend, Belgium.Results385 patients with AS on TNFi were analyzed, of them 327 men (85%) and 58 women (15%). Mean age of patients at the time of initiation of TNFi was 39.0 (±10.7) years. Total time on anti-TNF therapy was calculated on 1129 patient-years. 81 patients were exposed to infliximab for 274 PYs, 102 patients to etanercept for 394 PYs, 155 patients to adalimumab for 390 PYs, and 47 patients to golimumab for 72 PYs. Baseline disease activity was high with mean BASDAI 6.1 (±1.3), ESR 53.7 (±27.6) mm/h, CRP 37.3 (±28.5) mg/L, and significantly dropped during the treatment. 98.1% patients remained on therapy with TNFi in 3rd month, 87.1% in 1st year, 74.5% in 2nd year, 59.9% in 3rd year, and 47.8% in 4th year. Patients with infliximab remained on anti-TNF therapy significantly shorter (median 50.0 months), than patients with etanercept or adalimumab (both equally 78.0 months, p=0.0257). HR for discontinuation of infliximab was 1.65-times higher than for etanercept, and 1.8 times higher than for adalimumab. From baseline parameters only ESR (p=0.0004, 95% CI 1.0049-1.0172) and CRP (p=0.0005, 95% CI 1.0041-1.0146) influenced drug survival in AS patients, other parameters like age, gender, disease duration, HLA-B27+, BASDAI and BASFI had no influence. The most common reason of drug discontinuation was lost of efficacy (43.2%), following adverse events (24.8%), extra-articular manifestations (16%), incompliance (5.6%), death (4.8%), remission (1.6%) and other reasons (4%). Patients with infliximab had to stop their treatment mostly due to adverse events (38.7%), with etanercept due to worsening of extra-articular manifestations (34.2%) and with adalimumab due to loss of efficacy (61.1%).ConclusionsPatients with etanercept, following with adalimumab tend to remain longer on their therapy, compared to inflixima...
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