AimIn this study, efficacy, tolerability and safety of biosimilar adalimumab (Exemptia; Zydus Cadila) was compared with reference adalimumab (Humira; AbbVie) in patients with moderate to severe rheumatoid arthritis (RA).MethodIn this multicentre, prospective, randomized, double‐blind, active controlled parallel arm study, 120 patients with moderate to severe RA were given 40 mg of either test adalimumab (Exemptia) or reference adalimumab (Humira) by subcutaneous route every other week for 12 weeks. The primary endpoint was proportion of responders in two tretament groups by American College of Rheumatology 20 (ACR20) at week 12. The secondary endpoints were change in Disease Activity Score of 28 joints – C‐reactive protein (DAS28‐CRP) and proportion of patients with an ACR50 and ACR70 response in two treatment groups at week 12. Safety outcomes were also assessed.ResultsAfter 12 weeks, patients treated every other week with test adalimumab (Zydus Cadila) had statistically similar response rates as compared to reference adalimumab (AbbVie): ACR20 (82% vs. 79.2%; P > 0.7); ACR50 (46%, vs. 43.4%; P > 0.7); ACR70 (14% vs. 15.1%; P > 0.8). The change in DAS28‐CRP score was −2.1 ± 1.09 and −2.1 ± 1.21, in test and reference products, respectively. It was statistically significant compared to baseline, but not significantly different between the two products. Three serious adverse events and no death was reported during the study. Both adalimumab preparations were safe and well tolerated in this study.ConclusionThe results demonstrated biosimilarity with respect to efficacy, tolerability and safety of test adalimumab (Exemptia) and reference adalimumab (Humira) in patients with moderate to severe RA.

Introduction: Thyroid function disorders are among the most common endocrine diseases. Females are affected more than males, especially during the reproductive age. Hypothyroidism is the most prevalent type with a reported frequency of 2–5% worldwide. Thyroid hormones are essential for virtually all body tissues. So deficiency may affect hematopoiesis in bone marrow and eventually hematopoietic cells. Hematological abnormalities have frequently been reported in thyroid disorders. Anemia is frequently observed in patients with primary hypothyroidism. Objectives: To study the hematological changes and pattern of anemia in primary hypothyroid patients. Materials & Methods: This is a cross sectional study conducted on newly diagnosed 100 patients with primary hypothyroidism, between 18 –60 years. They were categorized as 35 patients of subclinical and 65 patients of overt hypothyroidism based on TSH level. Patients’ who fulfills the inclusion exclusion criteria were evaluated for thyroid function tests (T3, T4 and TSH) and hematological parameters (CBC and PBF). Results: Our analysis revealed an overall prevalence rate of anemia was 56% in patients with hypothyroidism which is higher than the WHO reported data of prevalence of anemia throughout the world. Our results showed that prevalence of normocytic normochromic anemia was significantly higher, microcytic anemia had the second rank, while macrocytic anemia had the lowest prevalence rate. On subgroup analysis, there was no statistical difference between subclinical hypothyroid and overt hypothyroid, in term of hematological parameters and type of anemia. Conclusion: Without proper diagnosis and effective treatment of the underlying thyroid disease, it is often difficult to achieve a complete correction of the anemia. The high prevalence of anemia in patients with hypothyroidism suggests screening for hypothyroidism during the differential diagnosis of cases presenting with anemia. Keywords: Hypothyroidism, subclinical, overt, anemia, hematological, thyroid, blood.

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