Adverse Drug Reactions in Rheumatoid Arthritis Patients Taking Combination DMARDs

Title: Adverse Drug Reactions in Rheumatoid Arthritis Patients Taking Combination DMARDs

Authors: Paramjeet Singh, Suyash Bharat, Mehar Bano, Sanjay Gaur, Bhavana Srivastava

DOI: http://dx.doi.org/10.18535/jmscr/v4i8.73

Abstract

References

Corresponding Author

Abstract

Aim - To ascertain the adverse drug reactions among RA patients taking combination DMARDs

Methods- It’s a prospective single centre controlled study. Patients of Reumatoid arthritis were divided into 2 study groups, Group-1 patients were given Methotrexate (MTX) oral weekly with Hydroxychloroquine oral daily. Group-2 patients were given Methotrexate (MTX) oral weekly with Salfasalazine oral daily in divided doses. Apart from the study medications, all patients were also given concomitant medications. The data was obtained from suspected ADRs reporting forms, between January 2014 to January 2015 from the Rheumatology OPD, Medicine department to the ADRs monitoring centre attached to department of Pharmacology under the Pharmacovigilance programme of India (PvPi). The reported ADRs were assessed for causality using WHO causality assessment scale. The severity was assessed using Hartwig and Siegel scale.

Observations: 131 patients who entered the study, 68 were study assigned to receive Methotrexate and Hydroxychloroquine (Group I) and 63 to receive Methotrexate and Sulfasalazine. In the study, in total 99 ADRs were reported from 53 ADR Forms. Most common occurring ADRs were nausea and vomiting in both the treatment groups. Different adverse drug reactions like nausea, blurring of vision, hyperpigmentation of skin, anaemia, epigastric pain, breathlessness were observed amongst patients in group-1.Whereas in group-2 patients the nausea, diarrhoea, headache, hepatotoxicity and leucopenia were seen.

Conclusions: DMARD’s combination cause more but tolerable adverse effects. Combination DMARD regimens are safe for use in Rheumatoid arthritis to control disease activity with tolerable, transient and reversible adverse effects.

Keywords - Rheumatoid arthritis, DMARDs, Adverse drug reactions (ADR).

References

1. Soderlin MK, Kautiainen H, Skogh T, Leirisalo-Repo M. Quality of life and economic burden of illness in very early arthritis. A population based study in southern Sweden. J Rheumatol 2004;31:1717–22.

2. Gheita TA. Transferring evidence from recent clinical rheumatology studies to those on the front lines. Int J ClinPract 2011;65(9):1016.

3. Raza K, Buckley C, Salmon M, Buckley C. Treating very early rheumatoid arthritis. Best Practice & Research Clinical Rheumatology. 2006;20(5):849-863.

4. Malaviya AN, Kapoor SK, Singh RR, Kumar A, Pande I. Prevalence of rheumatoid arthritis in the adult Indian population.Rheumatol Int. 1993; 13(4):131-4.

5. Doran M, Pond G, Crowson C, O'Fallon W, Gabriel S. Trends in incidence and mortality in rheumatoid arthritis in Rochester, Minnesota, over a forty-year period. Arthritis & Rheumatism. 2002; 46(3):625-631.

6. Kaipiainen O, Seppänen O, KautiainenH . Declining trend in the incidence of rheumatoid factor-positive rheumatoid arthritis in Finland 1980-2000. J Rheumatol 2006 33: 2132-8.

7. Gabriel S, Michaud K. Epidemiological studies in incidence, prevalence, mortality, and comorbidity of the rheumatic diseases. Arthritis Res Ther. 2009; 11(3):229.

8. Visser K, Katchamart W, Loza E, Martinez-Lopez J, Salliot C, Trudeau J et al. Multinational evidence-based reco-mmendations for the use of methotrexate in rheumatic disorders with a focus on rheumatoid arthritis: integrating systematic literature research and expert opinion of a broad international panel of rheumatologists in the 3E Initiative. Annals of the Rheumatic Diseases. 2008;68(7):1086-1093.

9. Visser K, van der Heijde D. Optimal dosage and route of administration of methotrexate in rheumatoid arthritis: a systematic review of the literature. Annals of the Rheumatic Diseases. 2008; 68(7):1094-1099.

10. Katzung B, Masters S, Trevor A. Basic & Clinical Pharmacology. 12th ed. United States of America: McGraw-Hill Companies, Inc; 2015.

11. McKenzie AH, Scherbel AL. Chloroquine and hydroxychloroquine in rheumatologi-cal therapy. Clin Rheum Dis 1980; 6:545–566.

12. Fransen J, van Riel P. The Disease Activity Score and the EULAR Response Criteria. Rheumatic Disease Clinics of North America. 2009;35(4):745-757

13. The use of the WHO–UMC system for standardised case causality assessment. Accessed from:http://www.WHO-UMC.org/graphics/4409.pdf

14. Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992;49:2229‑32

15. E. H. S. Choy, C. Smith, C. J. Dore´ and D. L. Scott, A meta-analysis of the efficacy and toxicity of combining disease-modifying anti-rheumatic drugs in rheumatoid arthritis based on patient withdrawal. Rheumatology 2005;44:1414–1421 doi:10.1093/rheumatology/kei031Advance Access publication 19 July 2005

16. Finbloom DS, Silver K, Newsom DA, Gunkel R .Comparison of Hydroxychloroquine and chloroquine use and development of retinal toxicity. J Rheumatol, 1985 ; 12:692–694.

17. O'Dell J, Leff R, Paulsen G, Haire C, Mallek J, Eckhoff P et al. Treatment of rheumatoid arthritis with methotrexate and hydroxychloroquine, methotrexate and sulfasalazine, or a combination of the three medications: Results of a two-year, randomized, double-blind, placebo-controlled trial. Arthritis & Rheumatism. 2002; 46(5):1164-1170.

18. Jallouli M. Hydroxychloroquine-Induced Pigmentation in Patients With Systemic Lupus Erythematosus. JAMA Dermatol. 2013; 149(8):935.

19. Granstein R, Sober A. Drug- and heavy metal-induced hyperpigmentation. Journal of the American Academy of Dermatology. 1981;5(1):1-18.

20. Munster T, Gibbs J, Shen D, Baethge B, Botstein G, Caldwell J et al. Hydroxychloroquine concentration-response relationships in patients with rheumatoid arthritis. Arthritis & Rheumatism. 2002; 46(6):1460-1469.

21. Dougados M, Combe B, Cantagrel A, Goupille P, Olive P, Schattenkirchner M et al. Combination therapy in early rheumatoid arthritis: a randomised, controlled, double blind 52Â week clinical trial of sulphasalazine and methotrexate compared with the single components. Annals of the Rheumatic Diseases. 1999;58(4):220-225.

22. Da Silva JA, Jacobs JW, Kirwan JR, Boers M, Saag KG, Ines LB, et al. Safety of low dose glucocorticoid treatment in rheumatoid arthritis: published evidence and prospective trial data. Ann Rheum Dis: 2006. 65: 285-93.

23. Bruce N. Cronstein. Low-Dose Methotrexate: A Mainstay in the Treatment of Rheumatoid Arthritis. Pharmacol Rev 57:163–172, 2005.

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