ABSTRACT
QUESTION: I have a patient planning pregnancy who has resistant rheumatoid arthritis that will require treatment with some of the "new" medications. Which ones are safe to use during pregnancy, and which ones do we know enough about to tell whether they are safe or not? ANSWER: For most new disease-modifying biologic medications, we have few data on safety. More and more reassuring data are accumulating on azathioprine and cyclosporine. When you treat this patient, you can help in gathering such data by contacting the Organization of Teratology Information Specialists' Autoimmune Disease in Pregnancy study through Motherisk at 877 311-8972.
Subject(s)
Abnormalities, Drug-Induced/diagnosis , Antirheumatic Agents/adverse effects , Pregnancy Complications/drug therapy , Pregnancy Outcome , Abnormalities, Drug-Induced/epidemiology , Antimalarials/administration & dosage , Antimalarials/adverse effects , Antirheumatic Agents/administration & dosage , Arthritis, Rheumatoid/diagnosis , Arthritis, Rheumatoid/drug therapy , Azathioprine/administration & dosage , Azathioprine/adverse effects , Female , Humans , Incidence , Information Services , Isoxazoles/administration & dosage , Isoxazoles/adverse effects , Leflunomide , Pregnancy , Pregnancy Trimester, First , Risk Assessment , Sulfasalazine/administration & dosage , Sulfasalazine/adverse effects , TeratogensABSTRACT
OBJECTIVE: Patients with psoriasis and psoriatic arthritis (PsA) commonly have nail involvement. There is no validated psoriatic nail assessment tool. Recently, investigators developed the Nail Psoriasis Severity Index (NAPSI). Beginning with NAPSI, our goal was to validate a psoriatic nail assessment tool for use in clinical trials, and investigate correlations between nail and other PsA features. METHODS: Fingernails of 29 patients with PsA were photographed and scored. Clinical data were collected. Using the original NAPSI, analysis revealed high interrater variability of nail scores. Twenty patients' photographs were regraded using the modified NAPSI (mNAPSI). RESULTS: The mNAPSI scores had excellent interrater reliability (Cronbach's alpha 0.98). Nail scores and physicians' global nail severity visual analog scores showed good inter- and intrarater correlations (Spearman's rho 0.85 and 0.90-0.99, respectively; p < 0.01). Several clinical measures correlated with nail scores. CONCLUSION: The mNAPSI demonstrated excellent interrater reliability and construct validity, and may be a valuable tool.
Subject(s)
Arthritis, Psoriatic/complications , Nail Diseases/etiology , Nail Diseases/pathology , Severity of Illness Index , Adult , Aged , Arthritis, Psoriatic/pathology , Female , Humans , Male , Middle Aged , Observer Variation , Reproducibility of Results , Sensitivity and SpecificityABSTRACT
For female patients with rheumatoid arthritis, the availability of a host of new disease modifying antirheumatic drugs has raised important questions about fetal safety if a woman becomes pregnant while she is being treated. In addition, there is limited safety information regarding many of the older medications commonly used to treat rheumatoid arthritis in women of reproductive age. Current summary pregnancy risk information for selected medications used to treat rheumatoid arthritis is reviewed in the context of the pregnancy label category. In addition, the strengths and weaknesses of post-marketing strategies for developing new pregnancy safety information are described.
