Gestational Desire and Certolizumab Pegol in Patients with Chronic Inflammatory Rheumatic Disease. Preliminary Results of the GESTAMAD Cohort

Background: The use of biological therapies during pregnancy has been contraindicated since the beginning of the use of these drugs. In recent years several studies have demonstrated the minimal-to-no transfer of certolizumab pegol (CZP) to the placenta and breast milk, which has allowed its approval for use in pregnancy and breastfeeding if clinically necessary. However, there are no studies evaluating the use of CZP during this period in real life or the characteristics of this subgroup of patients. Objectives: To describe the profile of women of childbearing age diagnosed with chronic inflammatory rheumatic disease (CIRD): Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and axial Spondyloarthritis (axSpA), who initiate CZP by gestational desire using the GESTAMAD registry (multicenter study of women with chronic inflammatory rheumatic disease of childbearing age who are initiated on CPZ by gestational desire from the Madrid community). Methods: Prospective multicenter study that aims to know the characteristics of women of childbearing age diagnosed with CIRD and gestational desire to which CZP is initiated for this reason. The comorbidities of the patients such as hypertension, diabetes and cardiovascular disease were collected. Disease activity was measured by DAS28 using CRP in RA and PsA and BASDAI in axSpA. The present study presents preliminary data from the initial cohort and will be followed prospectively for 24 months to assess the efficacy and safety of the drug during pre-conception, pregnancy and lactation. Results: A total of 45 patients have been recruited in 6 Madrid hospitals from June to December 2019. Patients had a mean age of 35.9, (36.6 in RA, 35.2 in PA and 35.1 in SPA). Fifty-one percent had RA, 20.0 percent had PA and 28.8 percent had SPA. The mean disease duration for RA, PA and SPA was 9.5, 7.3 and 6.9 years, respectively. 48.9% of women were nulliparous. The abortion rate of patients diagnosed with spondyloarthropathy was upper of 25%. 33.3% of the patients had been treated with previous biologicals, with gestational desire/pregnancy being the reason for the change. 75.5% of the patients had been treated with synthetic disease modifying antirheumatic drugs (DMARD) previously. With regard to disease activity, the mean DAS 28 at the start of treatment was 4.5 in RA and 3.8 in PA and BASDAI 7.0 in axSPA. In RA the highest values of CRP and ESR were found prior to initiation with CZP, but this difference was not statistically significant (p=0.644 and 0.605, respectively). 22.2% of patients had previous comorbidities. Conclusion: The mean age of patients with gestational desire in CIRD is high. Women diagnosed with PsA and axSpA have a high rate of previous abortions, upper than 25%. The duration of the disease is equally long at the time of manifesting gestational desire. The use of treatments such as CZP, compatible with pregnancy and lactation would allow a better control of inflammatory joint disease in this period of life, encouraging patients not to postpone their gestational desire. Disclosure of Interests: None declared