discontinuation criterion of an increase in creatinine by more than 50% of baseline. The clinical significance of the observed serum creatinine elevations is unknown.
Other Adverse Reactions
Adverse reactions occurring in 2% or more of patients on 5 mg twice daily or 10 mg twice daily XELJANZ and at least 1% greater than that observed in patients on placebo with or without DMARD are summarized in Table 4.
Table 4: Adverse Reactions Occurring in at Least 2% or More of Patients on 5 or 10 mg Twice Daily XELJANZ With or Without DMARD (0–3 months) and at Least 1% Greater Than That Observed in Rheumatoid Arthritis Patients on Placebo
XELJANZ
5 mg Twice Daily XELJANZ
10 mg Twice Daily* Placebo
Preferred Term N = 1336
(%) N = 1349
(%) N = 809
(%)
N reflects randomized and treated patients from the seven clinical trials
* The recommended dose of XELJANZ is 5 mg twice daily.
Diarrhea 4.0 2.9 2.3
Nasopharyngitis 3.8 2.8 2.8
Upper respiratory tract infection 4.5 3.8 3.3
Headache 4.3 3.4 2.1
Hypertension 1.6 2.3 1.1
Other adverse reactions occurring in controlled and open-label extension studies included:
Blood and lymphatic system disorders: Anemia
Infections and infestations: Diverticulitis
Metabolism and nutrition disorders: Dehydration
Psychiatric disorders: Insomnia
Nervous system disorders: Paresthesia
Respiratory, thoracic and mediastinal disorders: Dyspnea, cough, sinus congestion, interstitial lung disease (some fatal)
Gastrointestinal disorders: Abdominal pain, dyspepsia, vomiting, gastritis, nausea
Hepatobiliary disorders: Hepatic steatosis
Skin and subcutaneous tissue disorders: Rash, erythema, pruritus
Musculoskeletal, connective tissue and bone disorders: Musculoskeletal pain, arthralgia, tendonitis, joint swelling
Neoplasms benign, malignant and unspecified (including cysts and polyps): Non-melanoma skin cancers
General disorders and administration site conditions: Pyrexia, fatigue, peripheral edema
Clinical Experience in Methotrexate-Naïve Patients
Study VI was an active-controlled clinical trial in methotrexate-naïve patients [see CLINICAL STUDIES (14)]. The safety experience in these patients was consistent with Studies I–V.
Psoriatic Arthritis
XELJANZ 5 mg twice daily and 10 mg twice daily were studied in 2 double-blind Phase 3 clinical trials in patients with active psoriatic arthritis (PsA).
Study PsA-I (NCT01877668) had a duration of 12 months and enrolled patients who had an inadequate response to a nonbiologic DMARD and who were naïve to treatment with a TNF-inhibitor (TNFi). Study PsA-I included a 3-month placebo-controlled period and also included adalimumab 40 mg subcutaneously once every 2 weeks for 12 months.
Study PsA-II (NCT01882439) had a duration of 6 months and enrolled patients who had an inadequate response to at least one approved TNFi. This clinical trial included a 3-month placebo controlled period.
In these combined Phase 3 clinical trials, 238 patients were randomized and treated with XELJANZ 5 mg twice daily and 236 patients were randomized and treated with XELJANZ 10 mg twice daily. All patients in the clinical trials were required to receive treatment with a stable dose of a nonbiologic DMARD [the majority (79%) received methotrexate]. The study population randomized and |
