ABSTRACT
BackgroundRheumatologic patients treated with Rituximab (RTX) are at higher risk of severe COVID-19 and death. The B-cell depletive treatment significantly affects B cell functions involved in anti-SARS-CoV-2 response, leading to relevant impacts on the clinical and serological course of infection, long-term immunity, and vaccine responses. In light of these observations, pre-exposure prophylaxis (PrEP) of COVID-19 with Tixagevimab and Cilgavimab (TGM/CGM) was recently approved in Italy for all patients treated with RTX in the previous year, independently of their serological status against SARS-CoV-2.ObjectivesWe aimed to evaluate the efficacy and safety of TGM/CGM in a single-centre cohort of rheumatologic patients treated with RTX.MethodsFrom October 2022, all patients who had been treated with RTX in the previous 12 months and who underwent clinical assessment at our rheumatologic tertiary centre were screened for eligibility to PrEP of COVID-19 with TGM/CGM. According to the indications of the Italian Medicines Agency (AIFA), we excluded subjects with major cardiovascular risk factors and/or coagulation abnormalities;those who reported a previous allergic reaction to any anti-COVID19 vaccine were referred to an allergologist for an evaluation before TGM/CGM administration. Patients who agreed to be treated with TGM/CGM signed an informed consent. Clinical and demographic features were collected at baseline, and follow-up phone assessment was performed the day after and 1 month after TGM/CGM administration, to assess treatment tolerability and new COVID-19- related events. A descriptive analysis was performed.ResultsFrom 1 October 2022 to 31 December 2022, 90 subjects were screened for eligibility to TGM/CGM. Among them, 11 were excluded for contraindications due to comorbidities and 55 refused TGM/CGM administration. Among patients who agreed to receive PrEP of COVID-19, 21 received TGM/CGM before 31 December 2022 and 3 were scheduled for January2023. Patients treated with TGM/CGM had a mean age of 54 years (standard deviation: 17) and 19 (90.5%) were female;9 were affected by rheumatoid arthritis and 12 by other rheumatologic diseases (3 systemic lupus erythematosus, 2 systemic sclerosis, 1 Sjögren syndrome, 1 juvenile idiopathic arthritis, 3 anti-synthetase syndrome, 2 vasculitides). Most of them had completed the vaccination schedule against COVID-19 (19, 90.5%) and 9 (42.8%) reported an infectious event by SARS-CoV-2 in the previous year. One month after TGM/CGM administration, no patient reported adverse events related to TGM/CGM nor COVID-19 related symptoms.ConclusionPrEP of COVID-19 with TGM/CGM was well tolerated in our population of rheumatologic patients treated with RTX in the previous year and no COVID-19 related symptoms were observed in the month of follow-up after TGM/CGM administration. Future observations may provide further data on long-term efficacy of TGM/CGM in preventing COVID-19.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsMaria Manara Speakers bureau: Novartis, Angelini, Consultant of: Lilly, MSD, Manuel Sette: None declared, Laura Giudice: None declared, Martina Biggioggero: None declared, Nicoletta Del Papa Speakers bureau: Janssen, Boehringer-Ingelheim, Actelion, Ennio Giulio Favalli Speakers bureau: AbbVie, BMS, Celltrion, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, UCB, Consultant of: AbbVie, BMS, Celltrion, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, UCB, Maria Gerosa: None declared, Francesca Ingegnoli: None declared, Roberto Caporali Speakers bureau: AbbVie, Amgen, BMS, Celltrion, Fresenius, Galapagos, Janssen, Lilly, Novartis, Pfizer, UCB, Consultant of: AbbVie, Fresenius, Galapagos, Lilly, Novartis, Pfizer, UCB.
ABSTRACT
Background: Complex regional pain syndrome type-1 (CRPS-1) is a severely disabling pain syndrome characterized by sensory and vasomotor disturbance, swelling, and functional impairment. Persistence of signs and symptoms has been observed in up to 64% of cases until 5.8 yrs after the onset of manifestations. Long-term disability, such as irreversible functional limitation, has been reported in up to 28% of cases with severe consequences on workability. No scores are validated to evaluate residual disability. Bisphosphonates have the best efficacy profile, compared with other therapeutic approaches, but data on long-term effectiveness are lacking. Objectives: To retrospectively evaluate long-term residual disability in patients with CRPS-1 of hand or foot after treatment with IV Neridronate (IVNer). To identify predictors of residual disability. To quantify disease outcomes, such as patient's subjective perception and residual pain. To assess long-term safety profile. Methods: We retrospectively collected data of patients affected by CRPS-1, treated with IVNer, referred to a tertiary Rheumatology Centre between Feb 2013 and Dec 2020. Visual analogue scale (VAS) and McGill Questionnaire (McGQ) were used for pain assessment. Disabilities of the Arm, Shoulder and Hand (DASH) and American Orthopaedic Foot and Ankle Society's (AOFAS) ankle-hindfoot scale for hand and foot involvement, respectively, were administered to explore disability through a phone survey. This kind of investigation was preferred for Covid pandemic. Results: 106 patients with definite diagnosis of CRPS-1 were included, mean age±standard deviation 55.6±13 yrs, 67% females, mean follow up duration 56.3 months (range 14-94), 46.2% with hand involvement. The mean VAS score before treatment onset was 55.8±23.4mm, while the McGQ was 12.9±6.7 in the sensory domain, 4.9±3.3 in the affective domain and 17.8±9.2 on the total score. Based on the patient's subjective perception and the proposed semi-quantitative scale, 77.4% described themselves as fully recovered (FR), 15% partially recovered (PR), and 7.6% with persistent disease (PD). Comparison between baseline and follow-up VAS shows a significant reduction (55.8±23.4 vs 15.1±26.4, p<0.00001). Pain assessment by McGQ showed a significant improvement in global score (baseline vs follow-up 17.8±9.2 vs 3.9±7.8, p<0.00001), sensory (12.9±6.7 vs 2.7±5.7, p<0.00001) and affective (4.9±3.3 vs 1.2±2.3, p<0.00001) domains. According to DASH score, 79.2% of the patients were FR, 3.8% had some difficulties, but with overall preserved use of the upper limb, and 17.0% had permanent functional disability. According to AOFAS ankle-hindfoot scale 76.4% of patients were FR, 16.0% had partial recovery, and 7.6% had severe functional impairment. Percentages of DASH and AOFAS scores showed a complete accordance with patients' subjective perception (Figure 1a and b). The only predictor of long-term functional impairment for CRPS-1 in the hand was a delayed treatment compared to symptoms onset (p=0.02). No predictors were found for foot localization. No patients reported the occurrence of osteonecrosis of the jaw or atraumatic fractures/atypical fracture features. Conclusion: IVNer maintained a good long-term effectiveness and safety profile in the treatment of CRPS-1. The effectiveness of IVNer is maintained on both pain symptoms and function, in terms of reductions in the VAS, McGQ and in hand and foot disability scores.
ABSTRACT
Introduction: Anaemia in pregnancy is common with a prevalence of 25.11% in Malta in 2016 according to WHO statistics. According to British Society of Haematology (2019) anaemia is defined as a Haemoglobin (Hb) of less than 11.0g/dL in the first trimester of pregnancy and less than 10.5g/dL during second and third trimesters. The objective of this study was to establish the prevalence of anaemia in pregnant patients at Mater Dei Hospital. It aimed to determine whether screening for anaemia at 28 weeks’ gestation was performed, as recommended by NICE. Furthermore, the study assessed whether the COVID-19 pandemic had any impact on screening for anaemia in pregnancy. Methodology: All mothers who delivered at Mater Dei Hospital during the months of July to September 2019 and July to August 2020 were reviewed. Data was obtained by accessing manual birth registers and the online clinical manager system. Information collected included date of delivery, maternal demographics, Haemoglobin results and, gestational age at the time of blood testing. Results: A total of 1758 patients were included. 4.66% of patients were anaemic at booking (anaemia defined as a Hb <10.5g/dL) while 35.6% of patients were anaemic at delivery. 9.3% of patients in the 2019 cohort had a re-screening Hb taken between 27 to 29 weeks of pregnancy. While 10% of patients in the 2020 group had re-screening performed. Conclusion: We have determined that screening of anaemia at 28 weeks’ gestation is not a common practice at Mater Dei Hospital. There was no statistically significant difference between re-screening performed before the COVID-19 pandemic and during, therefore proving that the lack of re-screening in 2020 was not related to a pandemic issue but rather a lack of re-screening culture at Mater Dei Hospital. Implementation of a local protocol based on these guidelines is required and in turn a re-evaluation to assess for improved outcomes.