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1.
Curr Med Res Opin ; 37(7): 1099-1102, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-34011212

RESUMO

BACKGROUND: ABP 501 is a biosimilar to the anti-tumor necrosis factor-alfa monoclonal antibody adalimumab and despite its effectiveness and safety in the treatment of psoriasis was demonstrated in randomized clinical trials, no real-life data are available, in particular in patients undergoing non-medical switch from originator to biosimilar. METHODS: We retrospectively searched our clinical records for all patients receiving ABP 501 between March 10, 2019 and September 7, 2019 at our Department. Therefore, we identified 94 patients, 46 patients underwent non-medical switch from adalimumab reference product to ABP 501. RESULTS: In originator-naïve patients, mean PASI significantly improved from baseline to week 24 (p < .0001) in both Pso and PsA cohorts. In these patients, mean DAS-28 ESR improved with no significant differences from baseline. In patients undergoing non-medical switch from adalimumab reference product to ABP 501, no significant difference in PASI or DAS-28 ESR were observed from week 16 before switch to week 24 after switch. CONCLUSIONS: AB- 501 is an effective treatment for plaque-type psoriasis and psoriatic arthritis regardless if patients are originator-naïve or if they were switched from the reference product.


Assuntos
Artrite Psoriásica , Medicamentos Biossimilares , Psoríase , Adalimumab/uso terapêutico , Artrite Psoriásica/tratamento farmacológico , Medicamentos Biossimilares/uso terapêutico , Substituição de Medicamentos , Humanos , Psoríase/tratamento farmacológico , Estudos Retrospectivos , Resultado do Tratamento
2.
Biomed Microdevices ; 21(1): 10, 2019 01 10.
Artigo em Inglês | MEDLINE | ID: mdl-30631976

RESUMO

The number of procedures performed with robotic surgery may exceed one million globally in 2018. The continual lack of haptic feedback, however, forces surgeons to rely on visual cues in order to avoid breaking sutures due to excessive applied force. To mitigate this problem, the authors developed and validated a novel grasper-integrated system with biaxial shear sensing and haptic feedback to warn the operator prior to anticipated suture breakage. Furthermore, the design enables facile suture manipulation without a degradation in efficacy, as determined via measured tightness of resulting suture knots. Biaxial shear sensors were integrated with a da Vinci robotic surgical system. Novice subjects (n = 17) were instructed to tighten 10 knots, five times with the Haptic Feedback System (HFS) enabled, five times with the system disabled. Seven suture failures occurred in trials with HFS enabled while seventeen occurred in trials without feedback. The biaxial shear sensing system reduced the incidence of suture failure by 59% (p = 0.0371). It also resulted in 25% lower average applied force in comparison to trials without feedback (p = 0.00034), which is relevant because average force was observed to play a role in suture breakage (p = 0.03925). An observed 55% decrease in standard deviation of knot quality when using the HFS also indicates an improvement in consistency when using the feedback system. These results suggest this system may improve outcomes related to knot tying tasks in robotic surgery and reduce instances of suture failure while not degrading the quality of knots produced.


Assuntos
Teste de Materiais , Procedimentos Cirúrgicos Robóticos/instrumentação , Suturas , Resistência à Tração , Humanos , Procedimentos Cirúrgicos Robóticos/métodos
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