AB0350 DRUG SAFETY AND PREGNANCY OUTCOME IN INDIAN PATIENTS WITH RHEUMATOID ARTHRITIS (RA)

Background

Due to ethical issues conducting controlled trials to assess safety, teratogenicity of medicines to treat Rheumatoid Arthritis (RA) is not feasible and pregnant women are excluded from drug trials. Hence data concerning safety of arthritis medicines in RA is limited. To our knowledge no study is available from India regarding pregnancy outcome and drug safety in RA patients.

Objectives

Analyze safety of arthritis medicines and pregnancy outcome in Indian women suffering from RA.

Methods

Retrospective analysis of RA women with pregnancy treated at Punjab Rheumatology Immunology Centre, Ludhiana and DMC, Ludhiana between 2012 to 2022. Patients were classified as RA based on ACR/EULAR 2010 criteria. Compliance to treatment and additional medication usage was self-reported by the patients. Delivery of healthy baby was counted as successful while spontaneous abortion, MTP due to fetal abnormality were counted as adverse pregnancy outcome.

Results

77 patients (Mean age 31.3 years) and 82 pregnancies were evaluated. 68 were successful. 10 patients had 11 spontaneous abortions out of whom 4 subsequently had successful pregnancy. Anticardiolipin antibodies were negative in 7, not available in 3. Patient with 2 spontaneous abortions had a successful pregnancy following low molecular weight heparin treatment throughout pregnancy despite negative anticardiolipin antibodies. 3 patients underwent MTP due to antenatal fetal defects (Table 1). Most commonly used medicines during pregnancy were Sulfasalazine(SSZ), Hydroxychloroquine(HCQ), Low dose Prednisolone, Azathioprine(AZA) (Table 1). No specific teratogenicity pattern was identified. 3 patients without Methotrexate(MTX) and 1 patient without MTX+Leflunomide washout had successful pregnancy.

Conclusion

To our knowledge this is the first study evaluating drug safety and pregnancy outcome in Indian RA patients. Most RA patients can have successful pregnancy. SSZ, HCQ, Azathioprine and low dose prednisolone are safe during pregnancy. Limited data indicates patients can have successful pregnancy without observing MTX washout but more data is required.

REFERENCES:

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Acknowledgements:

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Disclosure of Interests

Parshant Aggarwal Speakers bureau: Novartis, not related to abstract submitted, Bharti Aggarwal: None declared, Vikas Gupta Speakers bureau: Janssen; not related to submitted abstract, Palak Gupta: None declared.