Humira 20 mg solution for injection in pre-filled syringe

Section 4.8 – Undesirable effects

• “Weight increased” is now listed in Table 7, under Investigations (Frequency: Not known). 
  
  The following corresponding information has been included in the footnotes:
  
  “The mean weight change from baseline for adalimumab ranged from 0.3 kg to 1.0 kg across adult indications compared to (minus) -0.4 kg to 0.4 kg for placebo over a treatment period of 4-6 months. Weight increase of 5-6 kg has also been observed in long-term extension studies with mean exposures of approximately 1-2 years without control group, particularly in patients with Crohn’s disease and Ulcerative colitis. The mechanism behind this effect is unclear but could be associated with the anti‑inflammatory effect of adalimumab.”

Section 10 – Date of Revision of the Text

• Amended to “04/2021”

Section 5.1

Repositioning of text

Section 5.2

Minor editorial changes

Section 10

Date of revision: 11/2020

Section 4.8 – Undesirable effects

• Addition of Kaposi’s sarcoma (frequency: not known) to Table 6

Section 10 – Date of Revision of the Text

• Amended to 08/2020

• Section 5.1 Pharmacodynamic properties
  Editorial change

Patients remained on stable doses of NSAIDs and or prednisone (£ 0.2 mg/kg/day or 10 mg/day maximum).

amended to: 

Patients remained on stable doses of non-steroidal anti-inflammatory drugs (NSAIDs) and or prednisone (£ 0.2 mg/kg/day or 10 mg/day maximum).
 

• Section 10. Date of Revision of Text
  Amended to 11/2019

Change to HPRA contact details

The following updates have been made to section 5.1 of the SmPC:

• Additional text describing enrolment into long term extension study
   Patients who completed Studies UV I and UV II were eligible to enroll in an uncontrolled long-term extension study with an originally planned duration of 78 weeks. Patients were allowed to continue on study medication beyond Week 78 until they had access to Humira.
   

• Revision of study summary
  • Revision of subject numbers
  • Explanation that the number of enrolled subjects declined but data at later timepoints generally consistent with week 78
  • Updated overall numbers for discontinuations based on full duration of study
    Of the 424 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 60 subjects were regarded ineligible (e.g. due to deviations or due to complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy. Of the 364 remaining patients, 269 evaluable patients (74%) reached 78 weeks of open-label adalimumab treatment. Based on the observed data approach, 216 (80.3%) were in quiescence (no active inflammatory lesions, AC cell grade  ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 178 (66.2%) were in steroid-free quiescence. BCVA was either improved or maintained (< 5 letters deterioration) in 88.6% of the eyes at week 78. Data beyond Week 78 were generally consistent with these results but the number of enrolled subjects declined after this time. Overall, among the patients who discontinued the study, 18% discontinued due to adverse events, and 8% due to insufficient response to adalimumab treatment.
     
     
    Date of Revision of text: updated to 05/2019

• Section 4.2 and section 4.4: “Patient Alert Card” changed to “Patient Reminder Card”.

Section  4.8

• Revised to include “lichenoid skin reaction” as a rare event under Skin and subcutaneous tissue disorders

Section 10

• Date of Revision of Text updated to 26 July 2018

Updat to section 4.6 - Fertility, pregnancy and lactation

New presentation