A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population

• Published in: Seminars in arthritis and rheumatism Vol. 48; no. 3; pp. 406 - 415
• Main Authors: Kivitz, Alan J., Cohen, Stanley, Keystone, Edward, van Vollenhoven, Ronald F., Haraoui, Boulos, Kaine, Jeffrey, Fan, Haiyun, Connell, Carol A., Bananis, Eustratios, Takiya, Liza, Fleischmann, Roy
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.12.2018
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; and ORAL Standard (NCT00853385); Antirheumatic Agents - adverse effects; Antirheumatic Agents - therapeutic use; Arthritis, Rheumatoid - drug therapy; Combination therapy; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Keywords; Male; Methotrexate - therapeutic use; Middle Aged; Monotherapy; ORAL Scan (NCT00847613); ORAL Solo (NCT00814307); ORAL Start (NCT01039688); ORAL Step (NCT00960440); ORAL Sync (NCT00856544); Piperidines - adverse effects; Piperidines - therapeutic use; Pyrimidines - adverse effects; Pyrimidines - therapeutic use; Pyrroles - adverse effects; Pyrroles - therapeutic use; Rheumatoid arthritis; Safety; Tofacitinib; Treatment Outcome; Young Adult; ORAL Sync (NCT00856544); Keywords; ORAL Step (NCT00960440); PY; Combination therapy; ORAL Scan (NCT00847613); Pts; MTX; HDL; SD; HZ; DAS28-4(ESR); LDL; MACE; and ORAL Standard (NCT00853385); ULN; Hb; Safety; BID; BMI; CI; DMARD; IR; SIE; RA; ORAL Solo (NCT00814307); ORAL Start (NCT01039688); Tofacitinib; Rheumatoid arthritis; SAE; TNFi; Monotherapy

This post-hoc, pooled analysis of Phase 3 studies of tofacitinib examined the safety of tofacitinib 5 and 10 mg twice daily (BID) when used as monotherapy versus combination therapy with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in patients with rheumatoid arthritis (RA...