News

BADBIR News Feed

This page lists all BADBIR study updates with the most recent on top. Some news items are superseded; they are clearly marked to show this. If you have any questions about any of the changes mentioned in a news item, please get in touch.


Recruitment to Amgevita (adalimumab biosimilar) will end 1st October

11/08/2020

Please be aware that BADBIR will not accept any new registrations at baseline for patients starting Amgevita (adalimumab biosimilar) after 30th September. Participants must have started Amgevita and provided consent before 1st October to be accepted.

This affects new registrations only. Patients already within the biologic cohort switching to Amgevita can be followed-up for BADBIR as normal.

Please visit the BADBIR Eligibility Page for details of currently accepted registration drugs.


Update from BADBIR (COVID-19)

23/03/2020

Dear Researchers

We have received a number of enquiries from participating BADBIR centres on our plans during this difficult period. This news item aims to answer the key questions on the Register, however if you have any queries not addressed here please contact the BADBIR team directly.

Recruitment status

Recruitment continues as normal and BADBIR remains fully open.

Remote clinic appointments

We understand many dermatology clinic appointments are being conducted remotely only (i.e. phone or video).

To help BADBIR capture this, we now ask at follow-up for confirmation on whether the appointment took place in person or remotely. Where remote clinic appointments have occurred, BADBIR follow-ups will still be paid for even where no PASI is recorded.

As an observational study, we will collect what information is taken when the patients are assessed regardless of whether this is an in-person clinic visit or one done remotely.

We ask that particular attention is paid to recording accurate information on drug exposure and adverse events.

Contacting the BADBIR team

We recommend using the BADBIR database to communicate directly with any information relating to individual participants. At present the office team are working remotely. To contact the BADBIR over the phone, please use the temporary number of 07557 545199.

COVID-19 adverse events

For suspected cases, please record as much information as possible on the symptoms and duration of illness during Adverse Event data entry. For confirmed cases which result in hospitalisation, we ask a Serious Infection ESI Form be completed. If in any doubt please contact the BADBIR team on via email badbir@manchester.ac.uk and we can provide further advice. We will also update the BADBIR website and database with further information on best practice data collection as required.

With best wishes

BADBIR


Conducting a BADBIR follow-up remotely

23/03/2020

We understand many dermatology clinic appointments are being conducted remotely only (i.e. phone or video).

To help BADBIR capture this, we now ask at follow-up for confirmation on whether the appointment took place in person or remotely. Please choose an option from the drop-down menu, which you will find on the first page of the follow-up.

Where remote clinic appointments have occurred, BADBIR follow-ups will still be paid for even where no PASI is recorded. As an observational study, we will collect what information is taken when the patients are assessed regardless of whether this is an in-person clinic visit or one done remotely.

We ask that particular attention is paid to recording accurate information on drug exposure and adverse events.


Temporary BADBIR Office Contact Details

19/03/2020

The BADBIR team based at the University of Manchester is following the national guidance surrounding the spread of COVID-19. The team is now working remotely until further notice.

BADBIR remains open for all recruitment and follow-up activities. The team will remain on hand to offer support. All database and email contact remains unchanged. Please note telephone advice:

  • 07557 545199 is the only phone number available to contact the BADBIR team directly. This will be manned during office hours Monday to Friday. If you would like to arrange a call back, please email badbir@manchester.ac.uk

Skyrizi (risankizumab) registrations now accepted

19/12/2019

We are pleased to announce that registrations to BADBIR can now be accepted for patients commencing on Skyrizi (risankizumab).

As with all new registrations, BADBIR inclusion criteria apply, meaning patients are eligible to join the Register if they sign consent within six months of commencing Skyrizi (risankizumab) for treatment of psoriasis.

Existing BADBIR participants switching to Skyrizi (risankizumab) can be followed up as usual. Please see our Eligibility Page for full details.

As a reminder, baseline registrations are currently accepted for the following treatments:

Biologic Cohort Small Molecule Cohort Conventional Cohort
Amgevita (Adalimumab biosimilar) Skilarence (dimethyl fumarate) Acitretin
Benepali (Etanercept biosimilar) Ciclosporin
Cimzia (Certolizumab pegol) Fumaric acid esters
Cosentyx (Secukinumab) Hydroxycarbamide
Erelzi (Etanercept biosimilar) Methotrexate
Hyrimoz (Adalimumab biosimilar) Systemic oral PUVA
Hyrimoz (Adalimumab biosimilar)
Ilumetri (Tildrakizumab)
Imraldi (Adalimumab biosimilar)
Kyntheum (Brodalumab)
Skyrizi (Risankizumab)
Taltz (Ixekizumab)
Tremfya (Guselkumab)
Zessly (Infliximab biosimilar)

Dose suggestion system for Stelara and Infliximab Biosimilars

18/09/2019

We have developed a system to suggest and automatically generate doses for the biologic therapies we enter with a frequency of "N/A". This can be found on the biologic therapy edit page.

First, you will be asked whether you know the dates of each individual dose during the follow-up period. If you choose "Yes" here, you can enter the dates, doses and batch numbers as normal. Choosing "No" here will present the next question.

If you choose "No" for the question above, you will be asked if, to the best of your knowledge, the patient deviated from the dose schedule. If the patient did not follow the normal schedule, choose "The patient deviated", and enter details in the text box that appears.

However, if you choose "The patient followed the schedule", you will be presented with the new dose suggestion system. It will scan through all of the existing doses in the drug record, suggest new doses to enter that fit the schedule of the drug, and show you a report on the doses already entered (see the key at the top).

The report will highlight doses that may be too early or too late, which will help you determine whether the patient deviated from the normal schedule. If you are happy with the doses highlighted in green being added for you, click "Add suggested doses". You can delete one or more of them afterwards if necessary.

You can restart these dose questions at any time, by clicking the "Restart the dose questions" button at the top of the section. You may find this system useful to check whether the existing doses match the expected schedule for that drug, even if you don't use it to enter them automatically.


Ilumetri (tildrakizumab) registrations now accepted

01/08/2019

We are pleased to announce that registrations to BADBIR can now be accepted for patients commencing on Ilumetri (tildrakizumab). As with all new registrations, BADBIR inclusion criteria apply; meaning patients are eligible to join the Register if they sign consent within six months of commencing Ilumetri (tildrakizumab) for treatment of psoriasis.

Existing BADBIR participants switching to Ilumetri (tildrakizumab) can be followed up as usual. Please see our eligibility page for full details.

For further information, please contact the BADBIR office.


Important updates to BADBIR with effect from 1st August 2019

01/08/2019

End of recruitment to Humira and Stelara

BADBIR no londer accepts new baseline registrations of patients commencing Humura (adalimumab) or Stelara (ustekinumab). All patients must be consented and have started treatment on 31st July or earlier to be included on the Register.

Pause to Otezla recruitment

There is a pause to recruitment for Otezla (apremilast) with effect from 1st August 2019. We will provide further updates as soon as possible. Please do not enter any registrations onto the database where a patient has commenced Otezla or consented after 31st July 2019.

For further information, please contact the BADBIR office.


Important Updates from BADBIR - June 2019

13/06/2019

Please note two important updates for the BADBIR study. These are also summarised in the Summer 2019 newsletter:

End of Recruitment to Humira and Stelara

With effect from 01/08/2019, BADBIR will no longer be able to accept new baseline registrations of patients commencing Humira (adalimumab) or Stelara (ustekinumab). All patients consented after 31st July will not be able to join the Register.

For patients already registered in the biologic cohort, follow-up can continue to be entered as normal for any changes to Humira or Stelara.

HADS Questionnaire

With effect from 17/06/2019, we will request that all patients complete the HADS questionnaire from baseline to follow-up 6. This questionnaire was approved for use last year in study amendment 11 and we have now received final permission from the licence holder to use HADS.

The data entry pages are open to collect the questionnaire. In the event of the HADS being missed, please remember to record 'No' to the 'Was a HADS Questionnaire completed?' question to avoid data queries.

Scores for both anxiety and depression will be automatically calculated on entry by the BADBIR database system, with high scores highlighted. Please see the link in the HADS section to some exemplar text that may be used/modified at your discretion to inform the patient's GP (or other appropriate health care professional) as per your usual clinical practice.


Adverse events data entry changes

01/06/2019

We have changed the way we collect adverse event descriptions on the BADBIR database. In order to obtain a more accurate picture of the event, we have split the description into three separate boxes:

Symptoms, Diagnosis and Treatment. If some of these details aren't available, please state this in the corresponding text box.

The purpose of this change is to make the data entry more efficient, and reduce the number of pharmocovigilance queries that are raised on adverse events.

The short description box will remain visible for a short period, but disabled for data entry.

An amended follow-up questionnaire is now on the website. If you have any questions regarding this change, please contact the office on 0161 306 1896.


Imraldi (Adalimumab biosimilar) registrations now accepted

20/05/2019

Registrations to BADBIR can now be accepted on patients commencing on Imraldi (Adalimumab biosimilar).

As with all new registrations, BADBIR inclusion criteria apply meaning patients are eligible to join the Register if they sign consent within six months of commencing Imraldi (Adalimumab biosimilar) for treatment of psoriasis.

Existing BADBIR participants switching to Imraldi (Adalimumab biosimilar) can be followed up as usual. Please see our Eligibility Page for a reminder on the full list of treatments the study is accepting registrations for.


BADBIR office move

18/04/2019

The BADBIR team are moving offices in the week of Monday 29th April. Please be aware there may be a short delay in responding to queries and emails during this week.

Details of the new postal address for BADBIR will be updated on the website, but most of the phone numbers will remain the same. Please check the Contact page for more details.


BADBIR will no longer be receiving faxes from May 1st

18/04/2019

With effect from May 1st 2019, BADBIR will no longer accept consent forms or other documentation sent by fax. The recommended method to send a consent form to us for a newly registered patient is to upload it directly to the database while data entry is completed.

For further advice please check the BADBIR website, or contact the office directly.


Members to join the BADBIR Steering Committee

07/03/2019

The British Association of Dermatologists (BAD) is looking for enthusiastic individuals to become members of the BAD Biologics and Immunomodulators Register (BADBIR) Steering Committee.

BADBIR is a UK and Eire observational study seeking to assess the long-term safety of biologic treatments for psoriasis. The Steering committee is responsible for the overall objectives of the study as well communicating to the BAD members and to patient care and representative organisations.

There are three meetings held each year (one in London and two in Manchester) and it is expected all members attend a minimum of two meetings. The term of appointment is for three years.

BADBIR will cover your travel expenses and provide lunch. If you would like to apply or would like to find out more, please contact Sagair Hussain (BAD Biologics Manager) - sagair@bad.org.uk.

The closing date for applications is: 30th April 2019

The next BADBIR Steering Committee meeting will be held on Wednesday 5th June.


Amgevita, Hyrimoz, Tremfya & Zessly registrations now accepted

20/12/2018

Registrations to BADBIR can now be accepted on patients commencing on the following treatments:

  • Amgevita (Adalimumab Biosimilar)
  • Hyrimoz (Adalimumab Biosimilar)
  • Tremfya (Guselkumab)
  • Zessly (Infliximab Biosimilar)

Existing BADBIR participants switching to any of these drugs can be followed up as usual. Please see the Eligibility Page for the full details.

The data entry pages will be updated early in 2019 to accommodate entry of these therapies though new participants can now be consented if starting on these treatments.


Kyntheum (brodalumab) registrations now accepted

05/11/2018

BADBIR is accepting Biologic Cohort registrations for patients commencing on Kyntheum (brodalumab).

As with all new registrations, BADBIR inclusion criteria apply meaning patients are eligible to join the Register if they sign consent within six months of commencing Kyntheum (brodalumab) for treatment of psoriasis.

Existing BADBIR participants switching to Kyntheum (brodalumab) can be followed up as usual.

Please see our Eligibility Page for a reminder on the full list of treatments the study is accepting registrations for.


Cimzia (certolizumab pegol) recruitment is starting

04/10/2018

We can now confirm that BADBIR is accepting registrations for patients commencing on Cimzia (certolizumab pegol).

BADBIR inclusion criteria apply, which means patients are eligible to join the Register if they sign consent within six months of commencing Cimzia (certolizumab pegol) for treatment of psoriasis.

Any current BADBIR patients switching to Cimzia (certolizumab pegol) can be followed up as usual.

Please see our Eligibility Page for full details of all the treatments we currently recruit for.


Skilarence (dimethyl fumarate) recruitment is starting

15/03/2018

We can now confirm that BADBIR is able to accept new registrations of patients commencing on Skilarence (dimethyl fumarate). This treatment is within the new non-biologic small molecule immunomodulator cohort on BADBIR.

Patients in the small molecule cohort should be naive to biologic therapy and sign consent within six months of commencing the registration treatment. Full eligibility criteria are on the BADBIR website.

Final changes are now being made to the database to allow entry of Small Molecule Immunomodulator cohort patients. At present, patients commencing Skilarence (dimethyl fumarate) may be consented now and entered on the database later once the development work is complete. If any currently registered BADBIR patients are commencing on Skilarence (dimethyl fumarate), please contact the BADBIR office for further advice (badbir@manchester.ac.uk / 0161 306 1896)


Supported Browsers for the BADBIR Database

12/01/2017

As part of ongoing development on the BADBIR database, after 31st January 2018 we will be unable to support older web browsers. The database will be inaccessible to older browsers after this date.

The BADBIR database will support the following web browsers:

  • Google Chrome version 48 or later (released in Jan 2015)
  • Microsoft Internet explorer version 11 (released in Oct 2013)
  • Microsoft Edge (any version)
  • Mozilla Firefox version 38 or later (released in Jan 2015)
  • Apple Safari version 8 or later (released in Oct 2014)

If you are unsure on what browser you are using and whether you need to take action, please consult your IT support. A simple way to check if your browser is unsupported will be to visit the database log-in page. If you see a message box advising you to update, this means you have an older browser. If there is no message onscreen, no action is required.

Further reminders will be provider closer to the deadline date. In the meantime please contact the BADBIR office with any queries (badbir@manchester.ac.uk / 0161 306 1896).


Otezla (apremilast) recruitment is starting

04/01/2018

We can now confirm that BADBIR is able to accept new registrations of patients commencing on Otezla (apremilast). This treatment is within the new non-biologic small molecule immunomodulator cohort on BADBIR.

Patients in the small molecule cohort should be naive to biologic therapy and sign consent within six months of commencing the registration treatment. Full eligibility criteria are on the BADBIR website.

Changes to the database are currently being made to allow entry of these patients. At present, patients commencing Otezla (apremilast) may be consented now and entered on the database later once the development work is complete. If any currently registered BADBIR patients are commencing on Otezla (apremilast), please contact the BADBIR office for further advice (badbir@manchester.ac.uk / 0161 306 1896).


Erelzi (etanercept biosimilar) recruitment is starting

04/01/2018

We can now confirm that BADBIR is able to accept new registrations of patients commencing on Erelzi (etanercept biosimilar). BADBIR inclusion criteria apply which means patients are eligible to join the Register if they sign consent within six months of commencing Erelzi (etanercept biosimilar).

Any current BADBIR patients switching to Erelzi (etanercept biosimilar) can be followed up as usual.


BADBIR Electronic Delegation Log is now live

14/06/2017

The Delegation Log for each BADBIR centre has changed. Previously, this was a paper document stored in the local site file. As an improvement measure for study governance, the log is now stored electronically within the BADBIR database.

Please can all users follow the link to the Electronic Delegation Log once logged in to the database, and review all of the entries for accuracy. Please pay particular attention to the following:

  • End dates for any staff no longer working on BADBIR
  • Whether the names of all current researchers at your centre are included
  • Spelling of the names on the delegation log

The process for new users applying for access to BADBIR has also changed. Please see the updated guidance on the database registration page for more information.

Please contact the office on 0161 306 1896 or badbir@manchester.ac.uk if any further information is required.


Taltz (Ixekizumab) recruitment is starting

01/11/2016

We can now confirm that BADBIR is able to accept new registrations of patients commencing on Taltz (Ixekizumab). BADBIR inclusion criteria apply which means patients are eligible to join the Register if they sign consent within six months of commencing Taltz (Ixekizumab).

Any current BADBIR patients switching to Taltz (Ixekizumab) can be followed up as usual.


Enbrel (Etanercept) recruitment has ended

01/08/2016

BADBIR has finished recruitment for patients commencing Enbrel as of 31st July 2016. Any patients who consent and/or start Enbrel after this date will not be eligible for entry onto BADBIR.

All BADBIR patients currently on Enbrel or switching to Enbrel at follow-up will continue to be followed up as per the BADBIR protocol. Recruitment continues to all other cohorts as usual.

Thanks to everyone for contributing to the recruitment of this cohort.


Benepali (Etanercept biosimilar) recruitment is starting

06/06/2016

BADBIR is now accepting all new registrations receiving Benepali and switches to this drug at follow-ups. All other eligibility criteria still apply.


Enbrel (Etanercept) recruitment is coming to an end on 31/07/2016

11/05/2016

Please be aware that recruitment of patients commencing on Enbrel will end after 31/07/2016. All patients who consent and/or start Enbrel after this date will not be eligible for entry on to BADBIR.

All BADBIR patients currently on Enbrel or on another biologic drug and switch to Enbrel will continue to be followed up as per the BADBIR protocol. Recruitment continues to all the other cohorts as usual.

Thanks to everyone for contributing to the recruitment of this cohort.


Addition of biosimilars to biologic list at follow-up

05/04/2016

With the first wave of biosimilars now on the market, BADBIR has added Inflectra (Infliximab) and Remsima (Infliximab) to the biologic drug list at follow-up. These are distinct treatments to the originator drug (Remicade) therefore it is important that BADBIR is made aware of any changes to treatment during follow-up data entry.

For example, if a patient had been switched from Remicade to Inflectra, a stop date would need to be recorded for the first treatment and a new start date input for the biosimilar.

Please contact the BADBIR office if you require any clarification.


Cosentyx (Secukinumab) recruitment started - message from BADBIR Chief Investigator

18/01/2016

Dear BADBIR Investigator,

We can now confirm that BADBIR is able to accept new registrations of patients commencing on Cosentyx. BADBIR inclusion criteria apply which means patients are eligible to join the Register if they sign consent within six months of commencing Cosentyx. Any current BADBIR patients switching to Cosentyx can be followed up as usual.

If you have any questions, please do not hesitate to contact us. Thank you for your continued contribution to BADBIR.

Kind regards,

Chris

Professor Chris Griffiths, BADBIR Chief Investigator


Humira (Adalimumab) recruitment resumed - message from BADBIR Chief Investigator

18/01/2016

Dear BADBIR Investigator,

At the end of last year, recruitment to Humira was paused while we applied for ethical approval to increase the cohort size to 5000 patients (BADBIR Protocol Amendment 9). This has been approved and therefore we are now in a position to accept registrations of participants starting on Humira. The process of circulating Amendment 9 to all the R & D departments is underway.

Please do not hesitate to contact the BADBIR office if you have any questions and thank you for your continued contribution to BADBIR.

Kind regards,

Chris

Professor Chris Griffiths, BADBIR Chief Investigator


SUPERSEDED

Humira (Adalimumab) funding secured - message from BADBIR Chief Investigator

30/11/2015

Dear BADBIR Investigator,

We are delighted to inform you that the BAD has secured funding to support continued recruitment to the Humira cohort. We will therefore apply for ethics committee approval to increase this cohort size to 5000 patients; subject to a positive opinion we will restart recruitment. The outcome of this application will be communicated to you as soon as we get a response from the ethics committee.

In the meantime if you have patients who have consented on or before the 16 November 2015, we will make individual arrangements for these to be entered so please contact us at badbir@manchester.ac.uk to arrange this. All BADBIR patients currently on Humira or on another biologic drug and switched to Humira will continued to be followed up as per the BADBIR protocol. Recruitment continues to all the other cohorts as usual.

Thanks to everyone for contributing to the recruitment of this very large cohort of patients.

Kind regards,

Chris

Professor Chris Griffiths, BADBIR Chief Investigator


SUPERSEDED

Humira (Adalimumab) cohort is full - message from BADBIR Chief Investigator

16/11/2015

Dear BADBIR Investigator,

The BADBIR protocol allocation of 4000 patients to the Humira cohort is now filled which of itself is great news and testimony to all of our BADBIR centres who are doing such a fantastic job with recruitment. While we await the outcome of discussion around funding for an increase in the Humira cohort we wish to pause new registrations for patients starting Humira as from 16/11/15 (patient date of consent). This includes those currently in the conventional cohort who switch to Humira. If you have patients who have already consented, we will make individual arrangements for these to be entered so please contact us at badbir@manchester.ac.uk to arrange this.

All BADBIR patients currently on Adalimumab (Humira) or on another biologic drug and switch to Humira will continued to be followed up as per the BADBIR protocol. Recruitment continues to all the other cohorts as usual.

Thanks to everyone for contributing to the recruitment of this very large cohort of patients.

Kind regards,

Chris

Professor Chris Griffiths, BADBIR Chief Investigator


BADBIR will start using Biologic Drug Trade Names

14/10/2015

Effective from Wednesday 14th October 2015, BADBIR database is using the trade name of biologic drugs instead of their originator names. All existing information has been updated. For example, Adalimumab now shows as Humira in the BADBIR database.

See the table below for the drugs affected by this change:

Originator NameTrade NameManufacturer
1AdalimumabHumiraAbbvie
2EtanerceptEnbrelPfizer
3InfliximabRemicadeMSD
4UstekinumabStelaraJanssen Cilag

If you have any concerns or are worried about how this can change the way you use the BADBIR database, please feel free to contact us.