RESUMO
OBJECTIVES: Determine domain-based-outcomes and steroid-sparing efficacy of generic tofacitinib in IIM. METHODS: This is a multicenter retrospective study wherein clinical phenotype, autoantibody profile, prior immunosuppressives, and outcomes at 3, 6, and 12 months were retrieved for IIM patients prescribed tofacitinib. Overall clinical response was assessed as complete or partial remission as per physician judgment. Changes in cutaneous and calcinosis domain were recorded as per physician global assessment (PGA), lung domain as per medical research council (MRC) dyspnea scale, and muscle strength by Manual Muscle Testing-8 (MMT-8). RESULTS: Forty-two patients of IIM with mean age 38.7 ± 16 years; (76.2% (N = 32) women), median duration of illness 48 (19;88) months were included. Commonest indication for initiating tofacitinib was either for refractory or as steroid sparing for cutaneous domain (N = 25/42, 59.5%) followed by calcinosis (N = 16/42, 38%). Overall complete and/or partial remission was achieved in 23/37 (64.8%), 30/35 (85.7%), and 29/30 (96.6%) patients at 3, 6, and 12 months, respectively. At 12-month follow-up, there was a reduction in prednisolone dose, with absolute decrease from a daily dose of 17.5 mg (IQR 5;50) to 2.5 mg (IQR 0;5) (p < 0.001). Individual domain assessments revealed improvement in cutaneous domain [16/25 (64%)] and calcinosis [6/15 (40%)]. Adverse effects included herpes zoster (N = 2/42, 4.8%) and dyslipidemia (N = 4/42, 9.5%). CONCLUSIONS: Treatment with generic tofacitinib significantly reduces the daily dose of corticosteroids and is effective in cutaneous domain including calcinosis in IIM. KEY POINTS: ⢠This multicenter retrospective study is the first real-world data from India, elucidating steroid sparing efficacy of generic tofacitinib in patients with inflammatory myositis. ⢠Domain-based outcome assessment suggests good clinical improvement especially in cutaneous domain, even those with refractory disease. ⢠Modest benefits were evident in calcinosis, but its effect on the muscle and pulmonary domain appears limited.
Assuntos
Miosite , Piperidinas , Pirimidinas , Sistema de Registros , Humanos , Feminino , Masculino , Pirimidinas/uso terapêutico , Estudos Retrospectivos , Adulto , Piperidinas/uso terapêutico , Pessoa de Meia-Idade , Miosite/tratamento farmacológico , Resultado do Tratamento , Índia , Indução de Remissão , Adulto Jovem , Inibidores de Proteínas Quinases/uso terapêutico , Pirróis/uso terapêuticoRESUMO
Metabolic parameters like uric acid, lipids and homocysteine are influenced by immunopathological mechanisms underlying the autoimmune disease processes. The current study examined the differences in these parameters and the correlation between inflammatory and metabolic variables in rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) patients. The cross-sectional prospective study included 24 treatment-naïve patients with moderate to severe diseases-15 subjects had RA and 9 had SLE. Atherogenic index of plasma (AIP) was used to assess the cardiovascular risk of the patients. Spearman's correlation was performed to verify the relationship between inflammatory and metabolic parameters. A two-tailed P < 0.05 was considered statistically significant for all the analysis. SLE patients had higher uric acid levels, very low density lipoprotein-cholesterol, total cholesterol/high density lipoprotein-cholesterol ratio (TC/HDL-C) and logarithmic ratio of triglycerides to HDL-cholesterol (log[TG/HDL-C]) than RA. Whereas, reduced total lymphocyte count, lipoprotein(a), and low density lipoprotein cholesterol were noted in the former than latter group. Majority of the SLE patients had increased risk of cardiovascular diseases (> 0.24 AIP score) and RA patients in comparison had lower risk. Correlation among serum uric acid, lipid profile constituents and AIP was noted. The immunological process of SLE has greater impact on the metabolic parameters. Higher uric acid levels are suggestive of dysfunctional lipid profile. Understanding the implications of risk factors and its inflammatory role in autoimmune processes may assist in disease management.